Page last updated: 2024-11-04

clomiphene

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Cross-References

ID SourceID
PubMed CID2800
CHEMBL ID2355051
CHEBI ID3752
SCHEMBL ID34893
MeSH IDM0004586

Synonyms (57)

Synonym
unii-1hrs458qu2
1hrs458qu2 ,
mer 41
DIVK1C_000462
KBIO1_000462
SPECTRUM_000101
CHEBI:3752 ,
clomifenum
2-[4-(2-chloro-1,2-diphenyl-vinyl)phenoxy]-n,n-diethyl-ethanamine
ethanamine, 2-[4-(2-chloro-1,2-diphenylethenyl)phenoxy]-n,n-diethyl-
DB00882
2-(p-(2-chloro-1,2-diphenylvinyl)phenoxy)triethylamine
2-(p-(beta-chloro-alpha-phenylstyryl)phenoxy)triethylamine
clomiphene b
ethanamine, 2-(4-(2-chloro-1,2-diphenylethenyl)phenoxy)-n,n-diethyl-
clomifeno [inn-spanish]
1-(p-(beta-diethylaminoethoxy)-phenyl)-1,2-diphenylchloroethylene
clomifene [inn:ban]
hsdb 3039
einecs 213-008-6
2-(p-(beta-chloro-alpha-phenylstyryl)phenoxy)-triethylamine
clomifenum [inn-latin]
KBIO2_003109
KBIO2_005677
KBIO2_000541
KBIOSS_000541
KBIO3_001273
KBIOGR_000848
SPBIO_002534
NINDS_000462
SPBIO_001037
PRESTWICK0_000397
SPECTRUM3_000357
SPECTRUM4_000294
PRESTWICK1_000397
SPECTRUM2_001139
NCGC00249615-01
dtxsid1022843 ,
NCGC00164385-04
gtpl4159
HMS3373N06
SCHEMBL34893
1-[p-(beta-diethylaminoethoxy)phenyl]-1,2-diphenylchloroethylene
GKIRPKYJQBWNGO-UHFFFAOYSA-N
CHEMBL2355051
FT-0696812
1-[4-(2-diethylaminoethoxy)phenyl]-1,2-diphenyl-2-chloroethylene
Q28208734
Q418730
SB17213
clomiphene free base
911-45-5 (free base)
2-(4-(2-chloro-1,2-diphenylethenyl)-phenoxy)-n,n-diethylethanamine
clomifeno (inn-spanish)
1-(p-(beta-diethylaminoethoxy)phenyl)-1,2-diphenylchloroethylene
clomifenum (inn-latin)
g03gb02

Research Excerpts

Bioavailability

ExcerptReferenceRelevance
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
estrogen antagonistA compound which inhibits or antagonises the biosynthesis or actions of estrogens.
estrogen receptor modulatorA substance that possess antiestrogenic actions but can also produce estrogenic effects as well. It acts as complete or partial agonist or as antagonist. It can be either steroidal or nonsteroidal in structure.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
tertiary amineA compound formally derived from ammonia by replacing three hydrogen atoms by hydrocarbyl groups.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (7)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
EWS/FLI fusion proteinHomo sapiens (human)Potency24.63010.001310.157742.8575AID1259252; AID1259253; AID1259255; AID1259256
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)71.50000.11007.190310.0000AID1449628; AID1473738
Androgen receptorRattus norvegicus (Norway rat)IC50 (µMol)13.48960.00101.979414.1600AID255211
5-hydroxytryptamine receptor 6Homo sapiens (human)Ki1.95600.00020.522910.0000AID691260
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (47)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
cerebral cortex cell migration5-hydroxytryptamine receptor 6Homo sapiens (human)
positive regulation of TOR signaling5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 6Homo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 6Homo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 6Homo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (27)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
histamine receptor activity5-hydroxytryptamine receptor 6Homo sapiens (human)
protein binding5-hydroxytryptamine receptor 6Homo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 6Homo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 6Homo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (20)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 6Homo sapiens (human)
cilium5-hydroxytryptamine receptor 6Homo sapiens (human)
synapse5-hydroxytryptamine receptor 6Homo sapiens (human)
dendrite5-hydroxytryptamine receptor 6Homo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 6Homo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (114)

Assay IDTitleYearJournalArticle
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID561223Antifungal activity against Saccharomyces cerevisiae BY4741 after 24 hrs by CLSI method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Antifungal activity of tamoxifen: in vitro and in vivo activities and mechanistic characterization.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1283245Inhibition of DR24 in Dhcr7-deficient mouse Neuro2a cells assessed as decrease in 7-DHC levels at 20 nM after 24 hrs by LC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID561225Antifungal activity against Candida albicans SC5314 after 24 hrs by CLSI method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Antifungal activity of tamoxifen: in vitro and in vivo activities and mechanistic characterization.
AID681359TP_TRANSPORTER: ATP hydrolysis in MDR1-expressing Sf9 cells1994Biochemical pharmacology, Jul-19, Volume: 48, Issue:2
Antiestrogens and steroid hormones: substrates of the human P-glycoprotein.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID103753Inhibition of MCF-7 cell proliferation at 5 uM1989Journal of medicinal chemistry, Jan, Volume: 32, Issue:1
Phenolic metabolites of clomiphene: [(E,Z)-2-[4-(1,2-diphenyl-2-chlorovinyl)phenoxy]ethyl]diethylamine. Preparation, electrophilicity, and effects in MCF 7 breast cancer cells.
AID1283269Inhibition of DR24 in Dhcr7-deficient mouse Neuro2a cells assessed as decrease in 7-DHC levels at 1 uM by LC-MS/GC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID1283244Inhibition of DR24 in Dhcr7-deficient mouse Neuro2a cells assessed as decrease in 7-DHC levels at 200 nM after 24 hrs by LC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID685500HARVARD: Cytotoxicity in HepG2 cell line2012Proceedings of the National Academy of Sciences of the United States of America, May-29, Volume: 109, Issue:22
Liver-stage malaria parasites vulnerable to diverse chemical scaffolds.
AID311932Inhibition of ASM in human H4 cells assessed as residual activity at 10 uM2008Journal of medicinal chemistry, Jan-24, Volume: 51, Issue:2
Identification of new functional inhibitors of acid sphingomyelinase using a structure-property-activity relation model.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1283249Inhibition of delta 8-7 isomerase in Dhcr7-deficient mouse Neuro2a cells assessed as increase in zymosterol levels at 1 uM by LC-MS/GC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID1283273Decrease in cholesterol levels in human SLOS fibroblasts at 10 nM after 5 days by LC-MS/GC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1283277Inhibition of delta 8-7 isomerase in Dhcr7-deficient mouse Neuro2a cells assessed as decrease in 7-DHC levels at 200 nM after 24 hrs by LC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID561228Antifungal activity against Candida glabrata MR084-G12 after 24 hrs by CLSI method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Antifungal activity of tamoxifen: in vitro and in vivo activities and mechanistic characterization.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1283262Inhibition of DR24 in human SLOS fibroblasts assessed as decrease in 7-DHC levels at 10 nM after 5 days by LC-MS/GC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID561230Antifungal activity against Cryptococcus neoformans NYS3-81 after 24 hrs by CLSI method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Antifungal activity of tamoxifen: in vitro and in vivo activities and mechanistic characterization.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID561231Antifungal activity against Cryptococcus neoformans KN99alpha after 24 hrs by CLSI method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Antifungal activity of tamoxifen: in vitro and in vivo activities and mechanistic characterization.
AID977599Inhibition of sodium fluorescein uptake in OATP1B1-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID561224Antifungal activity against Candida albicans ATCC 90028 after 24 hrs by CLSI method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Antifungal activity of tamoxifen: in vitro and in vivo activities and mechanistic characterization.
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID561227Antifungal activity against Candida dubliniensis CD1 after 24 hrs by CLSI method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Antifungal activity of tamoxifen: in vitro and in vivo activities and mechanistic characterization.
AID1283275Inhibition of DR24 in mouse Neuro2a cells assessed as decrease in 7-DHC levels at 1 uM by LC-MS/GC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID685501HARVARD: Inhibition of liver stage Plasmodium berghei infection in HepG2 cells2012Proceedings of the National Academy of Sciences of the United States of America, May-29, Volume: 109, Issue:22
Liver-stage malaria parasites vulnerable to diverse chemical scaffolds.
AID561226Antifungal activity against Candida parapsilosis R058-G12 after 24 hrs by CLSI method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Antifungal activity of tamoxifen: in vitro and in vivo activities and mechanistic characterization.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1283268Inhibition of delta 8-7 isomerase in Dhcr7-deficient mouse Neuro2a cells assessed as decrease in 7-DHC levels at 1 uM by LC-MS/GC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID1283267Cytotoxicity against human SLOS fibroblasts at 5 uM after 5 days by Cell Titer assay2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID497830Protection against fragile X syndrome phenotypes in laboratory prepared food feeded Fmr1 null mutant Drosophila Fmr1'3/TM6C assessed as homozygous Fmr1-/- embryo viability at 5 uM at 25 degC by flow cytometry relative to untreated homozygous embryos fed w2008Nature chemical biology, Apr, Volume: 4, Issue:4
Identification of small molecules rescuing fragile X syndrome phenotypes in Drosophila.
AID1283250Inhibition of delta 8-7 isomerase in Dhcr7-deficient mouse Neuro2a cells assessed as decrease in cholesterol levels at 1 uM by LC-MS/GC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID561229Antifungal activity against Candida tropicalis MR064-H after 24 hrs by CLSI method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Antifungal activity of tamoxifen: in vitro and in vivo activities and mechanistic characterization.
AID497827Protection against fragile X syndrome phenotypes in Fmr1 null mutant Drosophila Fmr1'3/TM6C assessed as embryo viability at 40 uM at 25 degC by flow cytometry relative to untreated homozygous embryos2008Nature chemical biology, Apr, Volume: 4, Issue:4
Identification of small molecules rescuing fragile X syndrome phenotypes in Drosophila.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID977602Inhibition of sodium fluorescein uptake in OATP1B3-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID691260Displacement of [3H]LSD from human 5HT6 receptor expressed in HEK293 cells after 1.5 hrs by liquid scintillation counting2012Journal of medicinal chemistry, Jun-28, Volume: 55, Issue:12
Chemocentric informatics approach to drug discovery: identification and experimental validation of selective estrogen receptor modulators as ligands of 5-hydroxytryptamine-6 receptors and as potential cognition enhancers.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1210014Inhibition of recombinant CYP2J2 (unknown origin)-mediated astemizole O-demethylation assessed as remaining activity at 30 uM after 5 mins by LC-MS/MS analysis relative to control2012Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 40, Issue:5
Identifying a selective substrate and inhibitor pair for the evaluation of CYP2J2 activity.
AID1210013Inhibition of recombinant CYP2J2 (unknown origin)-mediated terfenadine hydroxylation assessed as remaining activity at 30 uM after 5 mins by LC-MS analysis relative to control2012Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 40, Issue:5
Identifying a selective substrate and inhibitor pair for the evaluation of CYP2J2 activity.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID1283248Inhibition of delta 8-7 isomerase in Dhcr7-deficient mouse Neuro2a cells assessed as increase in zymostenol levels at 1 uM by LC-MS/GC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1449628Inhibition of human BSEP expressed in baculovirus transfected fall armyworm Sf21 cell membranes vesicles assessed as reduction in ATP-dependent [3H]-taurocholate transport into vesicles incubated for 5 mins by Topcount based rapid filtration method2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification.
AID561040Antifungal activity against Cryptococcus neoformans NYS2 assessed as disruption of cell wall integrity-associated adenylate kinase release at 64 ug/ml by hemocytometry2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Antifungal activity of tamoxifen: in vitro and in vivo activities and mechanistic characterization.
AID1283264Inhibition of delta 8-7 isomerase in human SLOS fibroblasts assessed as decrease in 7-DHC levels at 10 nM after 5 days by LC-MS/GC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID1283247Inhibition of delta 8-7 isomerase in mouse Neuro2a cells assessed as decrease in 7-DHC levels at 1 uM by LC-MS/GC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID255211Inhibitory concentration against recombinant rat androgen receptor expressed in Escherichia coli using [3H]methyltrienolone (R 1881)2005Journal of medicinal chemistry, Sep-08, Volume: 48, Issue:18
Impact of induced fit on ligand binding to the androgen receptor: a multidimensional QSAR study to predict endocrine-disrupting effects of environmental chemicals.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625295Drug Induced Liver Injury Prediction System (DILIps) validation dataset; compound DILI positive/negative as observed in Pfizer data2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1283278Inhibition of delta 8-7 isomerase in Dhcr7-deficient mouse Neuro2a cells assessed as decrease in 7-DHC levels at 20 nM after 24 hrs by LC-MS analysis2016Journal of medicinal chemistry, Feb-11, Volume: 59, Issue:3
The Effect of Small Molecules on Sterol Homeostasis: Measuring 7-Dehydrocholesterol in Dhcr7-Deficient Neuro2a Cells and Human Fibroblasts.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID561039Antifungal activity against Candida albicans SC5314 assessed as disruption of cell wall integrity-associated adenylate kinase release at 32 ug/ml by hemocytometry2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Antifungal activity of tamoxifen: in vitro and in vivo activities and mechanistic characterization.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (25)

TimeframeStudies, This Drug (%)All Drugs %
pre-19901 (4.00)18.7374
1990's1 (4.00)18.2507
2000's4 (16.00)29.6817
2010's14 (56.00)24.3611
2020's5 (20.00)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 99.46

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index99.46 (24.57)
Research Supply Index3.30 (2.92)
Research Growth Index5.32 (4.65)
Search Engine Demand Index198.41 (26.88)
Search Engine Supply Index2.28 (0.95)

This Compound (99.46)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials0 (0.00%)5.53%
Reviews1 (3.85%)6.00%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Other25 (96.15%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (151)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Oral Sildenafil Citrate: a Potential Approach for Improvement of Endometrial Thickness and Treatment of Unexplained Infertility in Women [NCT05846906]Phase 2/Phase 3130 participants (Actual)Interventional2021-10-01Completed
Minimal Stimulation or Clomiphene Citrate as First Line Therapy in Women With Polycystic Ovary Syndrome [NCT01157312]113 participants (Actual)Interventional2008-08-31Completed
Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene [NCT01289756]Phase 120 participants (Actual)Interventional2009-12-31Completed
Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy on Improvement of Endometrial Thickness and Treatment of Unexplained Infertility [NCT05753098]Phase 4148 participants (Actual)Interventional2021-01-15Completed
Evaluate the Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination [NCT01219101]Phase 495 participants (Actual)Interventional2011-03-31Completed
Is the Co-administration of Metformine and CC as Compared to Placebo and CC Superior to Induce Ovulation in PCOS Patients With a Confirmed insulin-resistant-a Double Blind Randomized Clinical Trial [NCT02523898]Phase 2388 participants (Anticipated)Interventional2015-11-30Enrolling by invitation
"Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility:A Clinical Research of Same Treatment for Different Diseases" [NCT03709849]Phase 2528 participants (Anticipated)Interventional2019-02-01Not yet recruiting
Adding Prednisolone During Ovulation Induction With Clomiphene Citrate in Lean Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome [NCT02344888]Phase 4300 participants (Anticipated)Interventional2015-02-28Recruiting
[NCT01569945]371 participants (Actual)Interventional2004-09-30Completed
A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects [NCT02117830]Phase 154 participants (Anticipated)Interventional2014-04-30Completed
FSH and LH Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women [NCT01340521]Phase 1/Phase 225 participants (Actual)Interventional1991-03-31Completed
PHASE 2b RANDOMIZED, PARALLEL, DOUBLE-BLIND, PLACEBO-CONTROLLED EXPLORATORY STUDY TO EVALUATE THE EFFICACY OF ANDROXAL IN IDIOPATHIC MALE INFERTILITY (PROTOCOL #01-14-40-08) [NCT02160704]Phase 2/Phase 30 participants (Actual)Interventional2014-09-22Withdrawn(stopped due to Difficult eligibility and lack of funding)
Intrauterine Infusion of Autologous Platelet-rich Plasma to Prevent a Thin Endometrium in Infertile Women Undergoing Clomiphene Citrate Therapy: a Pilot Prospective Self-controlled Trial [NCT03770026]Phase 2/Phase 330 participants (Actual)Interventional2018-01-01Completed
Clomiphene Citrate Versus Tamoxifen for Induction of Ovulation in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial [NCT02479256]Phase 4600 participants (Actual)Interventional2015-06-30Completed
Trigger or Not to Trigger? : An Answer for an Old Question [NCT02264847]Phase 3200 participants (Anticipated)Interventional2014-10-31Recruiting
Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole [NCT03241472]Phase 3100 participants (Actual)Interventional2016-02-29Completed
Metformin Use and Clinical Pregnancy Rate in Women With Unexplained Infertility [NCT03681197]Early Phase 1170 participants (Anticipated)Interventional2018-06-15Recruiting
Mild Stimulation Protocol Using Clomiphene Citrate / Gonadotropins Versus Conventional Stimulation Protocol for Women With PCOS Undergoing in Vitro Fertilization (IVF): a Prospective Non-randomized Controlled Trial [NCT04157725]Phase 4154 participants (Anticipated)Interventional2023-06-01Active, not recruiting
Evaluation of the Clinical Outcome of Vitamin E as Adjuvant Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome [NCT03674385]Phase 260 participants (Actual)Interventional2018-07-19Completed
Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome [NCT03630341]Phase 4150 participants (Actual)Interventional2016-02-01Completed
Effects of Vitamin D Supplementation on Reproductive, Hormonal and Metabolic Profiles, and on IVF Outcomes, in PCOS Infertile Saudi Women : a Randomized-controlled Clinical Trial [NCT05106712]700 participants (Anticipated)Interventional2021-11-01Not yet recruiting
Effect of Adding Vitamin D Supplement to Clomiphene Citrate for Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome [NCT03396380]Phase 3186 participants (Anticipated)Interventional2017-07-01Recruiting
Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility: Randomized Controlled Trial [NCT03549741]Phase 2/Phase 3120 participants (Anticipated)Interventional2018-07-31Not yet recruiting
Phase 3 Study Investigating the Effect of Endobarrier Treatment on Fertility in Women With Polycystic Ovary Syndrome [NCT02255578]Phase 350 participants (Anticipated)Interventional2014-09-30Not yet recruiting
Concomitant Clomiphene Citrate and Estradiol Versus Clomiphene Citrate Alone in Ovulation Induction: a Randomized Controlled Trial [NCT02186782]Phase 4600 participants (Anticipated)Interventional2014-06-30Recruiting
Clomiphene Citrate Plus Gonadotropins and GnRH Antagonist Versus Flexible GnRH Antagonist Protocol Versus Microdose GnRH Agonist Protocol in Poor Responders Undergoing IVF: a Randomized Study [NCT02201914]Phase 4250 participants (Anticipated)Interventional2014-01-31Recruiting
The Use of Mild Stimulation Protocol in Poor Responders : a Randomized Trial [NCT01213147]Phase 4159 participants (Actual)Interventional2009-04-30Completed
L-Carnitine and Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome [NCT03476356]106 participants (Actual)Interventional2017-11-01Completed
Hormone Replacement Therapy Versus Minimal Ovarian Stimulation for Endometrial Preparation Prior to Frozen-thawed Embryo Transfer in Non Polycystic Ovarian Syndrome Patients [NCT02330757]Phase 4150 participants (Anticipated)Interventional2016-10-10Recruiting
Extended Letrozole Regimen Versus Clomiphene Citrate for Superovulation in Patients With Unexplained Infertility Undergoing Intrauterine Insemination [NCT01232075]Phase 2214 participants (Actual)Interventional2008-09-30Completed
Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer [NCT03309436]Phase 4360 participants (Anticipated)Interventional2017-08-07Recruiting
Combined Coenzyme Q10 and Clomiphene Citrate for Ovulation Induction in Clomiphene-citrate-resistant Polycystic Ovary Syndrome [NCT04302532]Phase 4149 participants (Actual)Interventional2020-07-01Completed
Effect of Sildenafil Citrate on Pregnancy Rate in Women Undergoing Induction of Ovulation [NCT02890238]Phase 4100 participants (Anticipated)Interventional2016-08-31Recruiting
Cost-effective Treatment of Unexplained Infertility: A Prospective Multicenter, Double-blinded, Randomised Controlled Study [NCT06178523]Phase 4900 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Comparison of Tamoxifen and Clomiphene Citrate in Mild Stimulation IVF: a Prospective Cohort Study [NCT02690870]Phase 4210 participants (Anticipated)Interventional2017-01-31Not yet recruiting
Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism: Metabolic and Cardiovascular Effects. [NCT02380755]Phase 278 participants (Actual)Interventional2015-04-30Completed
Prospective Randomized Trial on the Effect of Clomiphene Citrate Administration in Women With Poor Ovarian Reserve Undergoing Controlled Ovarian Stimulation for IVF. Impact on Stimulation Characteristics and Pregnancy Outcome. [NCT02237755]Phase 2/Phase 350 participants (Anticipated)Interventional2014-10-31Not yet recruiting
Combined Letrozole and Clomid in Polycystic Ovary Syndrome: a Randomized Control Trial of Combination of Letrozole and Clomiphene Citrate or Letrozole Alone for the Treatment of Infertility in Women With Polycystic Ovary Syndrome [NCT02802865]Phase 470 participants (Actual)Interventional2016-08-31Completed
Luteal Phase Versus Follicular Phase Administration of Clomiphene Citrate in PCOS, A Randomized Controlled Trial [NCT02024984]Phase 190 participants (Anticipated)Interventional2013-11-30Recruiting
Combined Pioglitazone and Clomophene Citrate Versus Combined Metformin and Clomiphene Citrate as First Treatment in Infertile Women With Polycystic Ovary Syndrome [NCT03566225]Early Phase 1400 participants (Actual)Interventional2018-01-30Completed
Effect of Ubiquinol Supplementation on Ovulation Induction in Clomiphene Citrate Resistance [NCT04870502]Phase 2/Phase 3161 participants (Actual)Interventional2019-04-01Completed
A Randomized, Double-blind, Placebo-controlled Trial of Clomiphene Citrate of Clomiphene Citrate in Hypoandrogenism and Azoospermia [NCT02137265]0 participants (Actual)Interventional2015-09-30Withdrawn(stopped due to No funding obtained)
Use of Low Dose of Human Chorionic Gonadotropin During Ovulation Induction With Clomiphene Citrate in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome [NCT02436226]Phase 4300 participants (Actual)Interventional2016-03-31Completed
Therapeutic Effect of Vitamin D3 Supplementation to Clomiphene Citrate Resistant Polycystic Ovary Syndrome Women [NCT04010942]Phase 4120 participants (Actual)Interventional2018-04-01Completed
Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome [NCT02551367]Phase 2110 participants (Anticipated)Interventional2015-10-31Not yet recruiting
Pharmacokinetics and Hepatic Safety of EGCG [NCT04177693]Phase 139 participants (Actual)Interventional2020-11-24Completed
Myo-inositol Versus Clomiphene Citrate as First Line Treatment for Ovulation Induction in PCOS [NCT04306692]Phase 412 participants (Actual)Interventional2020-07-02Terminated(stopped due to clomiphene citrate is no longer being considered as standard treatment for polycystic ovary syndrome)
N-acetyl-cysteine in Clomiphene Citrate Resistant Polycystic Ovary Syndrome After Laparoscopic Ovarian Drilling: A Randomized Controlled Trial [NCT02775734]Phase 2/Phase 3144 participants (Actual)Interventional2016-05-31Completed
Clomiphene Citrate Plus Cabergoline Versus Clomiphene Citrate Alone in Treatment of Polycystic Ovary Syndrome Associated Infertility [NCT02644304]Phase 288 participants (Anticipated)Interventional2015-05-31Recruiting
A Comparison of Hormonal Profile and the Follicular Development Between Letrozole and Clomifene Citrate in Anovulatory Women With Polycystic Ovary Syndrome and Ovulatory Women [NCT02647424]40 participants (Anticipated)Interventional2015-12-31Recruiting
Among Non-IVF Patients Undergoing Ovulation Induction With Clomiphene Citrate (Clomid® 50 mg), Does Administration of an Increased Dose of Clomiphene Citrate (Clomid® 100 mg) Compared With Gonadotropins, Achieve Similar Rates of Folliculogenesis? [NCT00835744]Phase 440 participants (Actual)Interventional2008-08-31Completed
Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism [NCT00697814]Phase 215 participants (Actual)Interventional2004-06-30Completed
Correction of Vitamin D Deficiency and Its Effect on Ovulation Induction in Women With PCOS (VIDEO): A Feasibility RCT [NCT02656121]Phase 2300 participants (Actual)Interventional2016-02-29Completed
Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome [NCT00795808]Phase 4171 participants (Actual)Interventional2003-08-31Completed
The Effect of Incremental Clomiphene Citrate(CC) Doses in Successive Induction Cycles on the Endogenous Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Steroid Hormone Responses to Treatment [NCT04210765]Phase 450 participants (Actual)Interventional2019-08-02Completed
Protocol to Minimize Injections and Blood Draws for Women Undergoing Controlled Ovarian Hyperstimulation for in Vitro Fertilization [NCT02865681]4 participants (Actual)Interventional2016-07-01Completed
[NCT02638285]Phase 486 participants (Actual)Interventional2009-01-31Completed
An Open, Randomized, Parallel-Group, Multicentric, Comparative Study of Letrozole With Clomiphene Citrate for Induction of Ovulation in Anovulatory Infertility. [NCT00610077]Phase 355 participants (Actual)Interventional2004-12-31Completed
A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203 [NCT01386567]Phase 248 participants (Actual)Interventional2011-07-31Completed
Hypogonadotropic Hypogonadism in Obese Young Males [NCT03245827]Phase 29 participants (Actual)Interventional2019-04-01Terminated(stopped due to not enough recruitment)
Evaluation of the Effect of Pentoxifylline and α-Lipoic Acid as Adjunctive Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome [NCT05231980]Phase 2120 participants (Actual)Interventional2022-06-05Completed
Effect of Amlodipine and Clomid on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients [NCT02544776]60 participants (Actual)Interventional2015-01-31Completed
Different Variables Predicting Ovulatory Response Among Clomiphene Citrate Resistance and Clomiphene Citrate Sensitive Patients With Polycystic Ovarian Syndrome. [NCT04887402]100 participants (Anticipated)Observational [Patient Registry]2021-01-01Recruiting
Does Short-term Structured Exercise Training Program Plus Diet Intervention Improve Ovarian Sensitivity to Clomiphene Citrate in Polycystic Ovary Syndrome Patients (PCOS)? A Prospective Randomized Controlled Study [NCT01004068]Phase 496 participants (Actual)Interventional2008-02-29Completed
An Open-Label, Multiple Center Study to Evaluate the Safety and Efficacy of Androxalâ„¢ Treatment in Men With Secondary Hypogonadism Who Completed ZA-003 [NCT01067365]Phase 3104 participants (Actual)Interventional2006-03-31Completed
Clomiphene Citrate Plus HPuFSH Versus Letrozole Plus HPuFSH in Clomid Resistant Infertile PCOS Women [NCT01793038]160 participants (Anticipated)Interventional2013-03-31Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxalâ„¢ Treatment in Men With Secondary Hypogonadism [NCT00962637]Phase 3194 participants (Actual)Interventional2006-03-31Completed
[NCT00844350]Phase 2177 participants (Actual)Interventional2006-10-31Completed
Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome [NCT00427700]Phase 382 participants (Actual)Interventional2008-08-31Completed
Pulsatile Gonadotropin-releasing Hormone for Infertility in Non-obese Patients With Polycystic Ovary Syndrome [NCT03989024]Phase 478 participants (Anticipated)Interventional2019-07-01Not yet recruiting
A Comparison of Clomiphene Citrate Responses in Men With Hypothalamic Hypogonadism naïve to, and Previously Treated With, Testosterone [NCT01904734]Phase 242 participants (Actual)Interventional2012-10-31Completed
Combined Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in CC-resistant Patients With Polycystic Ovary Syndrome [NCT01910766]110 participants (Actual)Interventional2010-01-31Completed
The Comparison of Effect of Four Different Treatment Protocols: Antagonist/Letrozole Protocol, Microdose Flare-up Protocol, Antagonist/Clomiphene Protocol, Antagonist on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization; a Prospective Rand [NCT01948804]Phase 4100 participants (Anticipated)Interventional2014-01-31Not yet recruiting
Study of Stair-step Clomiphene Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome (PCOS) Compared to Traditional Protocol. [NCT01953796]140 participants (Actual)Interventional2010-05-31Completed
Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate [NCT05096169]Phase 240 participants (Anticipated)Interventional2022-05-01Recruiting
AN OPEN-LABEL, MULTIPLE DOSE STUDY TO ASSESS THE DRUG-DRUG INTERACTIONS OF ANDROXAL WITH CYTOCHROME P450 ISOENZYMES IN HEALTHY MALE SUBJECTS [NCT01991327]Phase 130 participants (Actual)Interventional2014-05-31Completed
Induction of Ovulation by Clomiphene Citrate Following Laparoscopic Surgery for Endometriosis Stage 1 and Stage 11 With and Without Suppression by Dienogest [NCT02575248]Phase 4310 participants (Anticipated)Interventional2014-10-31Recruiting
Comparisin CC/Gonadotropin/GnRH Antagonist and Gonadotropin/GnRH Agonist in IVF Outcome. [NCT00830492]Phase 4200 participants (Anticipated)Interventional2008-01-31Completed
The Added Value of n Acetyle Cysteine and Chromium to Clomiphene Citrate in PCO [NCT04170439]108 participants (Actual)Interventional2019-11-20Completed
The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene: A Randomized Controlled Trial. [NCT02663830]Phase 2210 participants (Actual)Interventional2016-01-10Completed
Letrozole and Sequential Clomiphene to Improve the Outcome of Embryo Transfer in Polycystic Ovary Syndrome (PCOS) Patients [NCT02775877]100 participants (Anticipated)Interventional2016-05-31Recruiting
Patients With Reduced Ovarian Reserve and In Vitro Fertilization (IVF) Cycles. A Randomized Multicentric Comparison of a Protocol With High Doses of Gonadotropins and a Protocol With Clomiphene Citrate Only. Evaluation of Clinical Effectiveness and Econom [NCT01389713]289 participants (Actual)Interventional2008-09-30Completed
Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome [NCT00471523]Phase 480 participants (Actual)Interventional2006-05-31Completed
Comparison of Recombinant Follicle Stimulating Hormone and the Combination of Recombinant Follicle Stimulating Hormone With Clomiphene Citrate in Stimulated Intrauterine Insemination Cycles: A Prospective Randomized Controlled Multicentric Study [NCT05670795]254 participants (Anticipated)Interventional2023-01-01Recruiting
Optimizing Fertility Treatment in Women With Polycystic Ovary Syndrome (PCOS) - A Randomized Controlled Trial: The Role of Progestin-induced Endometrial Shedding in PCOS (PIES in PCOS) [NCT01718444]27 participants (Actual)Interventional2015-03-31Terminated(stopped due to The primary investigator moved from academic practice to join a private group, and could not get any one to take over as PI for the study.)
Prospective Randomized Study of Ovulation Induction Using Either Tamoxifen or Clomiphene Citrate for Women Who Had Thin Endometrium During Previous Treatment With Clomiphene Citrate [NCT00449514]100 participants (Anticipated)Interventional2007-05-31Recruiting
How Long Should First-line Treatment be Continued in Infertile PCOS Patients Who Ovulate Under Clomiphene Citrate? A Randomized Controlled Clinical Study. [NCT00501839]Phase 40 participants (Actual)Interventional2008-08-31Withdrawn
What is the Following Step to Improve Fertility in Infertile PCOS Patients Ovulating Under Clomiphene Citrate or Metformin? A Randomized Controlled Clinical Study. [NCT00502229]Phase 40 participants (Actual)Interventional2010-01-31Withdrawn
Laparoscopic Ovarian Diathermy or Metformin Plus Clomiphene Citrate Administration as Second-Line Treatment for Infertile Anovulatory Patients With Polycystic Ovary Syndrome: a Randomized Controlled Trial [NCT00558077]Phase 450 participants (Actual)Interventional2003-02-28Completed
[NCT01784380]1,159 participants (Actual)Observational2006-10-31Completed
Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome: Randomised Control Trial [NCT05702957]Phase 2/Phase 3220 participants (Actual)Interventional2016-09-30Completed
A Randomized Double Blinded Placebo Controlled Trial Between Anastrozole and Clomiphene to Evaluate Improvement in Hypogonadal Symptoms and Erectile Function Using ADAM, IIEF and EHS Validated Scales [NCT03933618]Phase 224 participants (Actual)Interventional2015-04-02Completed
Double Ovarian Stimulation as Accumulation Strategy for Older Infertile Patients With Suboptimal Ovarian Response in Assisted Reproductive Treatment [NCT03400722]Phase 4120 participants (Anticipated)Interventional2017-12-01Recruiting
Pregnancy in Polycystic Ovary Syndrome: A 30 Week Double-Blind Randomized Trial of Clomiphene Citrate, Metformin XR, and Combined Clomiphene Citrate/Metformin XR For the Treatment of Infertility in Women With Polycystic Ovary Syndrome [NCT00068861]Phase 3678 participants Interventional2002-11-30Completed
Hormone Replacement Therapy Versus Minimal Ovarian Stimulation for Endometrial Preparation Prior to Frozen-thawed Embryo Transfer in Polycystic Ovarian Syndrome Patients [NCT02273791]126 participants (Actual)Observational2013-12-31Completed
Double Blind Cross-over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome [NCT00478504]Phase 4159 participants (Actual)Interventional2007-05-31Completed
Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation: A Double-blind, Placebo-controlled, Crossover Study [NCT01291056]20 participants (Actual)Interventional2010-01-31Completed
Comparison of Three Different Strategies for Treating Infertility in Anovulatory Women With Polycystic Ovary Syndrome: a Multicentre Randomized Controlled Clinical Trial [NCT00461643]Phase 4552 participants (Anticipated)Interventional2007-01-31Recruiting
Use of Clomiphene Citrate as an Inhibitor of Ovulation in an Oocyte Cryopreservation Cycle [NCT05866068]10 participants (Anticipated)Observational2023-07-01Not yet recruiting
Metformin for the Treatment of Unexplained Oligozspermia and Azoospermia [NCT01529177]Phase 4600 participants (Anticipated)Interventional2012-02-29Recruiting
A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety Profile of Androxal in Male Subjects With Impaired Renal Function [NCT01923857]Phase 126 participants (Actual)Interventional2013-08-31Completed
Interest of Clomiphene Citrate (CC) Associated With a Second Testicular Sperm Extraction (TESE) in Patients With Non-obstructive Azoospermia (NOA) After Failure of a First TESE, on the Quantity of Sperm Cells Available for Intracytoplasmic Sperm Injection [NCT03615547]Phase 3128 participants (Anticipated)Interventional2023-01-31Not yet recruiting
A 12 Month, Single Blind, Placebo Controlled, Phase III Study to Assess the Effects of Enclomiphene Citrate Treatment On Bone Mineral Density in Men With Secondary Hypogonadism [NCT01619683]Phase 3300 participants (Actual)Interventional2012-09-30Completed
Circulating Anti-mullerian Hormone as Predictor of Ovarian Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome [NCT03316469]40 participants (Anticipated)Interventional2018-07-31Not yet recruiting
Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation [NCT05206448]Phase 4189 participants (Actual)Interventional2020-10-26Active, not recruiting
Effect of Local Endometrial Injury on Pregnancy Outcomes During Ovulation Induction Cycles [NCT02345837]160 participants (Anticipated)Interventional2014-02-28Recruiting
The Effect of Metformin Added to Clomiphene Citrate on Pregnancy Rates in Hyperandrogenic, Chronic Oligoovulatory or Anovulatory Women: A Randomized Trial [NCT00413179]Phase 356 participants Interventional1997-12-31Completed
Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in Agonist Triggered GnRH Antagonist in Vitro Fertilization Cycles. Phase IV, Single-centre, Open-label, Controlled Clinical Trial. [NCT01791751]Phase 410 participants (Actual)Interventional2012-06-30Completed
A Randomized, Double Blind, Placebo and Active Controlled, Parallel, Multi-Center Phase IIb Study to Evaluate Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism [NCT01270841]Phase 283 participants (Actual)Interventional2011-01-31Completed
A Double-Blind Crossover Study In Healthy Volunteers to Compare Two Formulations of Androxal [NCT01984398]Phase 116 participants (Actual)Interventional2013-12-31Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Administered Intravenously or Subcutaneously (Via Portable Infusion Pump) Compared to Oral Treatment With Clomi [NCT00296465]Phase 2/Phase 3132 participants (Actual)Interventional2005-02-28Completed
Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome (PCOS) and a Resistance to Insulin. Randomised Controlled Study [NCT01638988]Phase 30 participants (Actual)Interventional2013-09-30Withdrawn(stopped due to Previous studies have been done regarding same condition)
An Open Label, 6 Month Phase III Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism [NCT01739582]Phase 3300 participants (Anticipated)Interventional2012-11-30Completed
A Randomized, Double Blind, Placebo Controlled Multi-Center Phase III Study to Evaluate Normalization of Morning Testosterone Levels in Overweight Men With Acquired Hypogonadotropic Hypogonadism and Normal Sperm Concentration [NCT01532414]Phase 3151 participants (Actual)Interventional2012-08-31Completed
Sex Hormone Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial [NCT04944836]Phase 258 participants (Anticipated)Interventional2023-03-09Recruiting
A Study to Evaluate the Efficacy of Androxal® in Improving Glycemic Control in Men With Secondary Hypogonadism or Adult-onset Idiopathic Hypogonadotropic Hypogonadism (AIHH) and Type 2 Diabetes Mellitus With Sub-Optimum Treatment [NCT01191320]Phase 2102 participants (Actual)Interventional2010-10-31Completed
[NCT02377479]0 participants (Actual)Interventional2015-03-31Withdrawn(stopped due to Study never started)
A Randomized, Single Blind, Multi-Center Phase II Study to Evaluate the Effect of Three Different Doses of Androxal and AndroGel on 24-Hour Luteinizing Hormone and Testosterone in Normal Healthy Men [NCT01386606]Phase 260 participants (Actual)Interventional2011-06-30Completed
Traditional Clomiphene Citrate Administration Versus a Stair-Step Approach: A Randomized Controlled Trial [NCT01008319]Phase 3120 participants (Actual)Interventional2009-10-31Completed
Phytoestrogens as an Alternative to Estradiol in Reversing the Antiestrogenic Effect of Clomid on Endometrium in Ovulation Induction in Cases of Polycystic Ovarian Syndrome [NCT02352597]Phase 4150 participants (Actual)Interventional2013-01-31Completed
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch (Lutrepatch) Compared to Oral Treatment With Clomiphene Citr [NCT00796289]Phase 2350 participants (Actual)Interventional2009-02-28Completed
Effect of Raloxifene on Ovulation in Women With Polycystic Ovarian Syndrome. [NCT01607320]3 participants (Actual)Interventional2012-06-30Terminated(stopped due to Over budget, slow recruitment, and personnel change)
[NCT00005104]99 participants Interventional2000-01-31Completed
Clomiphene Citrate Stair-step Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome: A Randomized Clinical Trial [NCT03178500]60 participants (Anticipated)Interventional2017-02-01Recruiting
Randomized Prospective Controlled Non-inferiority Trial of Low-dose Clomiphene Based Antagonist Protocol vs. High Dose Gonadotropin/Antagonist Protocol for IVF Poor Responders [NCT01577199]Phase 40 participants (Actual)Interventional2012-04-30Withdrawn(stopped due to no subjects recruited)
Letrozole Versus Clomiphene Citrate Plus Metformin in the First Treatment of Infertility in Patients With Polycystic Ovarian Syndrome [NCT01679574]200 participants (Actual)Interventional2009-01-31Completed
An Open Label Study to Evaluate the Pharmacokinetics and Safety Profile of Androxal in Male Subjects With Impaired Hepatic Function [NCT01923870]Phase 119 participants (Actual)Interventional2013-08-31Completed
Effect of High BMI on Ovulation Induction Using Letrozole Versus Clomid [NCT04331197]Phase 4160 participants (Anticipated)Interventional2020-05-01Not yet recruiting
[NCT00005654]88 participants Interventional2000-01-31Completed
Randomized Controlled Trial Evaluating the Timing of Intrauterine Insemination in Relation to the LH Surge [NCT02294773]13 participants (Actual)Interventional2013-10-31Completed
Combined Letrozole-metformin-pioglitazone Versus Combined Clomiphene Citrate-metformin-pioglitazone in Clomiphene Citrate-resistant Women With Polycystic Ovary Syndrome [NCT01909141]Early Phase 1100 participants (Actual)Interventional2013-08-31Completed
A Dose Escalating Study To Determine the Tolerability and Pharmacokinetics of a Single Dose of Androxal in Healthy Volunteers [NCT01959685]Phase 19 participants (Actual)Interventional2013-10-31Completed
Effect of Sildenafil Vaginal Gel Co-treatment With Clomiphene Citrate on Endometrial Thickness in Infertile Women With Prior Clomiphene Citrate Failure Due to Thin Endometrium: a Prospective Self-controlled Clinical Trial [NCT02710981]42 participants (Actual)Interventional2015-06-30Completed
Effect of Hypogonadotropic Hypogonadism and Replacement With Clomiphene Citrate and Testosterone on Insulin Sensitivity, Body Composition, Inflammation, Sexual Function and Spermatogenesis in Young Type 2 Diabetic Men [NCT01155518]Phase 25 participants (Actual)Interventional2010-06-30Terminated(stopped due to lack of funding)
Extended Clomiphene Citrate Regimen Versus Laparoscopic Ovarian Drilling for Ovulation Induction in Clomiphene Citrate-resistant Women With Polycystic Ovary Syndrome [NCT02381184]Phase 2/Phase 3160 participants (Actual)Interventional2014-06-30Completed
An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism [NCT01534208]Phase 3499 participants (Actual)Interventional2012-05-31Completed
A Randomized, Open-Label, Fixed Dose, Active-Control, Multi-Center Phase IIB Study to Evaluate Fertility in Men With Secondary Hypogonadism, Comparing Androxal® to a Topical Testosterone in Men Previously Treated With Topical Testosterone. [NCT00706719]Phase 217 participants (Actual)Interventional2008-06-30Completed
Growth Hormone Pretreatment in Poseidon Type IV Undergoing ICSI Using Minimal Induction Protocol: A Randomized Controlled Trial [NCT05089344]132 participants (Anticipated)Interventional2021-10-09Recruiting
Administration of Clomiphene: Short and Long Term Metabolism in an Anti-Doping Setting [NCT03028532]Phase 112 participants (Actual)Interventional2017-03-13Completed
A Randomized, Double Blind, Placebo Controlled Multi-Center Phase III Study to Evaluate Normalization of Morning Testosterone Levels in Overweight Men With Acquired Hypogonadotropic Hypogonadism and Normal Sperm Concentration [NCT01739595]Phase 3181 participants (Actual)Interventional2012-11-30Completed
A Phase II, Prospective, Randomized, Double-Blind, Multicenter, Dose Finding, Comparative Study for the Evaluation of the Aromatase Inhibitor Anastrozole (Multiple-Dose) Versus Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile [NCT00213148]Phase 2271 participants (Actual)Interventional2005-03-10Completed
Clomiphene Citrate for Treatment of Acromegaly Not Controlled by Conventional Therapies [NCT02274311]Phase 216 participants (Actual)Interventional2011-01-31Completed
Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation [NCT01044862]Phase 3900 participants (Actual)Interventional2010-06-30Completed
A 20 Week Double-Blind Randomized Trial of Clomiphene Citrate and Letrozole for the Treatment of Infertility in Women With Polycystic Ovary Syndrome [NCT00719186]Phase 3750 participants (Actual)Interventional2009-02-28Completed
The Effect Of Vitamin D Replacement Therapy On Serum Leptin And Follicular Growth Pattern In Women With Resistant Polycystic Ovarian Syndrome [NCT03806036]Phase 4100 participants (Anticipated)Interventional2018-01-02Recruiting
Maximal Stimulation and Delayed Fertilization for Diminished Ovarian Reserve: a Randomized Pilot Study [NCT01921166]Phase 423 participants (Actual)Interventional2011-01-31Completed
Comparative Study of Pregnancy Rate After Endometrial Injury in Couples With Unexplained Infertility [NCT03398993]100 participants (Anticipated)Interventional2018-01-31Not yet recruiting
Determining the Fertility Benefit of Immediate SO+IUI After Operative Laparoscopy in Patients With Advanced Stage Endometriosis [NCT02520505]0 participants (Actual)Interventional2015-04-30Withdrawn(stopped due to no participants enrolled)
Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate [NCT03059173]Phase 3276 participants (Anticipated)Interventional2022-03-31Not yet recruiting
A Randomized, Double Blind, Placebo-Controlled, Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 m [NCT02651688]Phase 250 participants (Actual)Interventional2016-01-11Completed
Clomiphene Citrate for the Treatment of Opioid-Induced Androgen Deficiency: Randomized Controlled Clinical Trial [NCT01880086]Phase 213 participants (Actual)Interventional2013-08-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00213148 (2) [back to overview]Ovulation Rate in Cycle 1
NCT00213148 (2) [back to overview]Number of Subjects With Clinical Pregnancy in Cycle 1
NCT00427700 (2) [back to overview]Serum Levels of Progesterone
NCT00427700 (2) [back to overview]Percentage of Participants With Ovulation Detected by Ultrasound
NCT00706719 (5) [back to overview]Motile Total Sperm Count
NCT00706719 (5) [back to overview]Semen Volume
NCT00706719 (5) [back to overview]Follicle Stimulating Hormone (FSH) Levels
NCT00706719 (5) [back to overview]Luteinizing Hormone (LH) Levels
NCT00706719 (5) [back to overview]Sperm Concentration
NCT00719186 (5) [back to overview]Number of Serious Adverse Events
NCT00719186 (5) [back to overview]Live Birth
NCT00719186 (5) [back to overview]Number of Ovulations
NCT00719186 (5) [back to overview]Neonatal Complication Rate
NCT00719186 (5) [back to overview]Number of Pregnancy
NCT01008319 (2) [back to overview]Time to Ovulation With Each Protocol
NCT01008319 (2) [back to overview]Delivery Outcomes
NCT01044862 (4) [back to overview]Time to Pregnancy
NCT01044862 (4) [back to overview]Rate of Pregnancy Obtained
NCT01044862 (4) [back to overview]Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH.
NCT01044862 (4) [back to overview]Live Birth Rate
NCT01191320 (1) [back to overview]Change in HbA1C
NCT01270841 (4) [back to overview]Change in FSH After 3 Months of Treatment
NCT01270841 (4) [back to overview]Change in Luteinizing Hormone Levels
NCT01270841 (4) [back to overview]Change in Total Morning Testosterone
NCT01270841 (4) [back to overview]Reproductive Safety
NCT01291056 (4) [back to overview]Luteal Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment
NCT01291056 (4) [back to overview]Luteal Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment
NCT01291056 (4) [back to overview]Follicular Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment
NCT01291056 (4) [back to overview]Follicular Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment
NCT01386606 (7) [back to overview]Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.
NCT01386606 (7) [back to overview]Change in Leuteinizing Hormone (LH)
NCT01386606 (7) [back to overview]Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.
NCT01386606 (7) [back to overview]Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.
NCT01386606 (7) [back to overview]Morning Testosterone Correlated With Serial Testosterone.
NCT01386606 (7) [back to overview]24 Hour Average and Maximum Testosterone Concentration
NCT01386606 (7) [back to overview]Change in Follicle Stimulating Hormone (FSH)
NCT01532414 (2) [back to overview]Subjects With 50% or Greater Decrease in Sperm Concentration Comparison of Proportion of Subjects With 50% or Greater Decrease in Sperm
NCT01532414 (2) [back to overview]Proportion (Percentage) of Androxal Treated Subjects With Testosterone in the Normal Range
NCT01534208 (6) [back to overview]Change From Baseline in LH
NCT01534208 (6) [back to overview]Absolute Values of Morning Testosterone
NCT01534208 (6) [back to overview]Change From Baseline in BMI
NCT01534208 (6) [back to overview]Change From Baseline in FSH
NCT01534208 (6) [back to overview]Mean Change From Baseline FPG
NCT01534208 (6) [back to overview]Change From Baseline in Total Morning Testosterone at 26 Weeks
NCT01739595 (2) [back to overview]Change in Sperm Concentration
NCT01739595 (2) [back to overview]Subjects With Testosterone in Normal Range After Treatment
NCT01880086 (7) [back to overview]Sexual Health Inventory for Men (SHIM) Questionnaire
NCT01880086 (7) [back to overview]Androgen Deficiency in the Aging Male (ADAM) Questionnaire
NCT01880086 (7) [back to overview]Estradiol
NCT01880086 (7) [back to overview]Hematocrit (%)
NCT01880086 (7) [back to overview]Men's Sexual Health Questionnaire (MSHQ) Questionnaire
NCT01880086 (7) [back to overview]Other Hormonal Profile (Change From Baseline)
NCT01880086 (7) [back to overview]Serum Total Testosterone (Change From Baseline)
NCT01909141 (5) [back to overview]Safety of Pioglitazone as Regards Serum Creatinine
NCT01909141 (5) [back to overview]Endometrial Thickness
NCT01909141 (5) [back to overview]Number of Follicles>18mm.
NCT01909141 (5) [back to overview]Ovulation Rate
NCT01909141 (5) [back to overview]Pregnancy Rate
NCT01921166 (2) [back to overview]Number of Oocytes Vitrified
NCT01921166 (2) [back to overview]Oocytes
NCT01959685 (2) [back to overview]Cmax of a Single Dose of 250 mg Androxal
NCT01959685 (2) [back to overview]Pharmacokinetics
NCT01984398 (2) [back to overview]Androxal Cmax Formulation B
NCT01984398 (2) [back to overview]Androxal Cmax Formulation A
NCT02274311 (3) [back to overview]IGF-1 Levels
NCT02274311 (3) [back to overview]PSA Levels
NCT02274311 (3) [back to overview]Testosterone Levels
NCT02294773 (5) [back to overview]Number of Pregnancies Achieved Per Menstrual Cycle.
NCT02294773 (5) [back to overview]Pregnancy Rate Per Semen Morphology Score
NCT02294773 (5) [back to overview]Pregnancy Rate Per Female Partner Age
NCT02294773 (5) [back to overview]Pregnancy Rate Per Body Mass Index Category
NCT02294773 (5) [back to overview]Per Cycle Pregnancy Rate Based on Infertility Diagnosis
NCT02651688 (20) [back to overview]Change From Baseline in Blood Testosterone (T) Level at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Homeostatic Model of Assessment - Insulin Resistance (HOMA-IR) at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Lean Body Mass (LBM) at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Ratio of Dihydrotestosterone: Testosterone (DHT:T) at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Ratio of Testosterone: Estradiol (T:E2) at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Waist Circumference at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Weight at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Blood Dihydrotestosterone (DHT) Level at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Blood Estradiol (E2) Level at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Blood Glucose Level at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Blood Interleukin-6 (IL-6) Level at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Blood Leptin Level at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Blood Luteinizing Hormone (LH) Level at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Blood Quantose-Insulin Resistance (IR) Score at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Blood C-reactive Protein (CRP) Level at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Blood Tumor Necrosis Factor Alpha (TNF-α) Level at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Body Mass Index (BMI) at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Body Strength (Chest Press Weight) at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Body Strength (Leg Press Weight) at Week 48
NCT02651688 (20) [back to overview]Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 48
NCT02710981 (3) [back to overview]Clinical Pregnancy Rate
NCT02710981 (3) [back to overview]Uterine Blood Flow
NCT02710981 (3) [back to overview]Endometrial Thickness
NCT02802865 (9) [back to overview]Number of Developing Follicles
NCT02802865 (9) [back to overview]Multiple Gestation
NCT02802865 (9) [back to overview]Live Birth
NCT02802865 (9) [back to overview]Endometrial Thickness
NCT02802865 (9) [back to overview]Conception
NCT02802865 (9) [back to overview]Size of Largest Developing Follicle
NCT02802865 (9) [back to overview]Pregnancy Loss
NCT02802865 (9) [back to overview]Number of Participants Achieving Ovulation Measured by Mid-luteal Progesterone Level
NCT02802865 (9) [back to overview]Clinical Pregnancy
NCT03245827 (1) [back to overview]Serum Free Testosterone
NCT03933618 (95) [back to overview]ADAM (Androgen Deficiency in the Aging Male) Score - Week 24
NCT03933618 (95) [back to overview]SEP #1-3 Cumulative - Week 8
NCT03933618 (95) [back to overview]SEP #1-3 Cumulative - Week 8
NCT03933618 (95) [back to overview]SEP #1-3 Cumulative - Week 8
NCT03933618 (95) [back to overview]SHBG - Screen
NCT03933618 (95) [back to overview]SHBG - Screen
NCT03933618 (95) [back to overview]SHBG - Week 16
NCT03933618 (95) [back to overview]SHBG - Week 16
NCT03933618 (95) [back to overview]SHBG - Week 24
NCT03933618 (95) [back to overview]SHBG - Week 24
NCT03933618 (95) [back to overview]SHBG - Week 24
NCT03933618 (95) [back to overview]SHBG - Week 8
NCT03933618 (95) [back to overview]SHBG - Week 8
NCT03933618 (95) [back to overview]ADAM (Androgen Deficiency in the Aging Male) Score - Screen
NCT03933618 (95) [back to overview]ADAM (Androgen Deficiency in the Aging Male) Score - Week 16
NCT03933618 (95) [back to overview]SEP #1-3 Cumulative - Week 8
NCT03933618 (95) [back to overview]ADAM (Androgen Deficiency in the Aging Male) Score - Week 16
NCT03933618 (95) [back to overview]ADAM (Androgen Deficiency in the Aging Male) Score - Week 24
NCT03933618 (95) [back to overview]ADAM (Androgen Deficiency in the Aging Male) Score - Week 24
NCT03933618 (95) [back to overview]ADAM (Androgen Deficiency in the Aging Male) Score - Week 8
NCT03933618 (95) [back to overview]ADAM (Androgen Deficiency in the Aging Male) Score - Week 8
NCT03933618 (95) [back to overview]EHS (Erectile Hardness Score) - Screen
NCT03933618 (95) [back to overview]EHS (Erectile Hardness Score) - Week 16
NCT03933618 (95) [back to overview]EHS (Erectile Hardness Score) - Week 16
NCT03933618 (95) [back to overview]EHS (Erectile Hardness Score) - Week 24
NCT03933618 (95) [back to overview]EHS (Erectile Hardness Score) - Week 24
NCT03933618 (95) [back to overview]EHS (Erectile Hardness Score) - Week 24
NCT03933618 (95) [back to overview]EHS (Erectile Hardness Score) - Week 8
NCT03933618 (95) [back to overview]Estradiol - Screen
NCT03933618 (95) [back to overview]Estradiol - Screen
NCT03933618 (95) [back to overview]Estradiol - Week 16
NCT03933618 (95) [back to overview]Estradiol - Week 16
NCT03933618 (95) [back to overview]Estradiol - Week 16
NCT03933618 (95) [back to overview]Estradiol - Week 24
NCT03933618 (95) [back to overview]Estradiol - Week 24
NCT03933618 (95) [back to overview]Estradiol - Week 24
NCT03933618 (95) [back to overview]Estradiol - Week 8
NCT03933618 (95) [back to overview]Estradiol - Week 8
NCT03933618 (95) [back to overview]Estradiol - Week 8
NCT03933618 (95) [back to overview]Free Testosterone - Screen
NCT03933618 (95) [back to overview]Free Testosterone - Screen
NCT03933618 (95) [back to overview]Free Testosterone - Screen
NCT03933618 (95) [back to overview]Free Testosterone - Week 16
NCT03933618 (95) [back to overview]Free Testosterone - Week 16
NCT03933618 (95) [back to overview]Free Testosterone - Week 16
NCT03933618 (95) [back to overview]Free Testosterone - Week 24
NCT03933618 (95) [back to overview]Free Testosterone - Week 24
NCT03933618 (95) [back to overview]Free Testosterone - Week 24
NCT03933618 (95) [back to overview]Free Testosterone - Week 24
NCT03933618 (95) [back to overview]Free Testosterone - Week 24
NCT03933618 (95) [back to overview]Free Testosterone - Week 8
NCT03933618 (95) [back to overview]Free Testosterone - Week 8
NCT03933618 (95) [back to overview]Free Testosterone - Week 8
NCT03933618 (95) [back to overview]Free Testosterone - Week 8
NCT03933618 (95) [back to overview]FSH - Screen
NCT03933618 (95) [back to overview]FSH - Screen
NCT03933618 (95) [back to overview]FSH - Week 16
NCT03933618 (95) [back to overview]FSH - Week 16
NCT03933618 (95) [back to overview]FSH - Week 24
NCT03933618 (95) [back to overview]FSH - Week 24
NCT03933618 (95) [back to overview]FSH - Week 24
NCT03933618 (95) [back to overview]FSH - Week 8
NCT03933618 (95) [back to overview]FSH - Week 8
NCT03933618 (95) [back to overview]IIEF (International Index of Erectile Function) Score - Screen
NCT03933618 (95) [back to overview]IIEF (International Index of Erectile Function) Score - Week 16
NCT03933618 (95) [back to overview]IIEF (International Index of Erectile Function) Score - Week 16
NCT03933618 (95) [back to overview]IIEF (International Index of Erectile Function) Score - Week 24
NCT03933618 (95) [back to overview]IIEF (International Index of Erectile Function) Score - Week 24
NCT03933618 (95) [back to overview]IIEF (International Index of Erectile Function) Score - Week 8
NCT03933618 (95) [back to overview]IIEF (International Index of Erectile Function) Score - Week 24
NCT03933618 (95) [back to overview]LH - Screen
NCT03933618 (95) [back to overview]LH - Screen
NCT03933618 (95) [back to overview]LH - Week 16
NCT03933618 (95) [back to overview]LH - Week 16
NCT03933618 (95) [back to overview]LH - Week 24
NCT03933618 (95) [back to overview]LH - Week 24
NCT03933618 (95) [back to overview]LH - Week 24
NCT03933618 (95) [back to overview]LH - Week 8
NCT03933618 (95) [back to overview]LH - Week 8
NCT03933618 (95) [back to overview]Normalized Testosterone - Screen
NCT03933618 (95) [back to overview]Normalized Testosterone - Screen
NCT03933618 (95) [back to overview]Normalized Testosterone - Week 16
NCT03933618 (95) [back to overview]Normalized Testosterone - Week 16
NCT03933618 (95) [back to overview]Normalized Testosterone - Week 24
NCT03933618 (95) [back to overview]Normalized Testosterone - Week 24
NCT03933618 (95) [back to overview]Normalized Testosterone - Week 24
NCT03933618 (95) [back to overview]Normalized Testosterone - Week 8
NCT03933618 (95) [back to overview]Normalized Testosterone - Week 8
NCT03933618 (95) [back to overview]SEP #1-3 Cumulative - Week 16
NCT03933618 (95) [back to overview]SEP #1-3 Cumulative - Week 16
NCT03933618 (95) [back to overview]SEP #1-3 Cumulative - Week 16
NCT03933618 (95) [back to overview]SEP #1-3 Cumulative - Week 24
NCT03933618 (95) [back to overview]SEP #1-3 Cumulative - Week 24
NCT03933618 (95) [back to overview]SEP #1-3 Cumulative - Week 24
NCT03933618 (95) [back to overview]SEP #1-3 Cumulative - Week 24
NCT04177693 (11) [back to overview]Changes in Endometrial Thickness
NCT04177693 (11) [back to overview]Changes in ALT/SGPT
NCT04177693 (11) [back to overview]Changes in Alkaline Phosphatase
NCT04177693 (11) [back to overview]Change in Serum Folate Level Between MTHFR677-Wild Type (WT) Group and MTHFR677-Hetero Group
NCT04177693 (11) [back to overview]Change in Serum Folate Level Between MTHFR1298-Wild Type (WT) Group and MTHFR1298-Hetero Group
NCT04177693 (11) [back to overview]Change in Serum Folate Level Between DHFR-Wild Type (WT) Group and DHFR-Hetero or Homo Group.
NCT04177693 (11) [back to overview]Changes in Total Bilirubin
NCT04177693 (11) [back to overview]Changes in Estrogen (E2)
NCT04177693 (11) [back to overview]Changes in Epigallocatechin Gallate (EGCG)
NCT04177693 (11) [back to overview]Changes in Epigallocatechin (EGC)
NCT04177693 (11) [back to overview]Changes in Epicatechin Gallate(ECG)

Ovulation Rate in Cycle 1

Ovulation rate was defined as the percentage of subjects who ovulated (mid-luteal Progesteron [P4] level greater than or equal to [>=] 10 nanogram per milliliter [ng/mL] and/or pregnancy). (NCT00213148)
Timeframe: Up to 1 month

Interventionpercentage of subjects (Number)
Clomiphene Citrate 50 mg64.9
Anastrozole 1 mg30.4
Anastrozole 5 mg36.8
Anastrozole 10 mg35.9

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Number of Subjects With Clinical Pregnancy in Cycle 1

Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity. (NCT00213148)
Timeframe: Up to 1 month

Interventionsubjects (Number)
Clomiphene Citrate 50 mg10
Anastrozole 1 mg4
Anastrozole 5 mg7
Anastrozole 10 mg0

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Serum Levels of Progesterone

The level of serum progesterone that indicated ovulation was considered to be 3 ng/mL or greater, on days 8 to 10 after ovulation. (NCT00427700)
Timeframe: 8-10 days after ovulation

Interventionng/mL (Mean)
Clomiphene26.1
Raloxiphene40

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Percentage of Participants With Ovulation Detected by Ultrasound

Ovulation detected by ultrasound was defined as the percentage of a participants with ovulation detected by ultrasound, defined as the dominant follicle and its subsequent collapse. If a dominant follicle was not observed by day 21 after menses, the ovulation induction was considered to be a failure. (NCT00427700)
Timeframe: cycle day 14-20

Interventionpercentage of participants (Number)
Clomiphene52.5
Raloxifene40.4

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Motile Total Sperm Count

Motile total sperm count was measured. (NCT00706719)
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)

,
Interventionmillions sperm (Mean)
BaselineMonth 3Month 6Follow-Up (Month 7)
Group A Testim0.32.4240.438
Group B Androxal no Wash Out99.0214.7146.9100.3

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Semen Volume

Semen volume was measured. (NCT00706719)
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)

,
InterventionmL (Mean)
BaselineMonth 3Month 6Follow-Up (Month 7)
Group A Testim2.342.881.903.34
Group B Androxal no Wash Out2.232.452.482.40

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Follicle Stimulating Hormone (FSH) Levels

FSH levels were measured. (NCT00706719)
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)

,
InterventionmIU/mL (Mean)
BaselineMonth 3Month 6Follow-Up (Month 7)
Group A Testim3.381.060.93.6
Group B Androxal no Wash Out1.584.535.482.38

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Luteinizing Hormone (LH) Levels

LH levels were measured. (NCT00706719)
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)

,
InterventionmIU/mL (Mean)
BaselineMonth 3Month 6Follow-Up (Month 7)
Group A Testim3.400.880.602.68
Group B Androxal no Wash Out2.925.706.122.47

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Sperm Concentration

Total sperm concentration was measured. (NCT00706719)
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)

,
Interventionmillions sperm/mL (Mean)
BaselineMonth 3Month 6Follow-Up (Month 7)
Group A Testim0.543.0023.1421.03
Group B Androxal no Wash Out72.8182.6168.5164.0

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Number of Serious Adverse Events

(NCT00719186)
Timeframe: as few as 5 months, up to 16 months

Interventionevents (Number)
Arm A: Clomiphene Citrate13
Arm B: Letrozole22

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Live Birth

The primary outcome measure is the occurrence of a live birth during the study period. Safety measures will be the number and type of reported adverse events in subjects and offspring. (NCT00719186)
Timeframe: as few as 5 months, up to 16 months

InterventionParticipants (Count of Participants)
Arm A: Clomiphene Citrate72
Arm B: Letrozole103

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Number of Ovulations

(NCT00719186)
Timeframe: as few as 5 months, up to 16 months

Interventionovulations (Number)
Arm A: Clomiphene Citrate331
Arm B: Letrozole388

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Neonatal Complication Rate

(NCT00719186)
Timeframe: September 2008 - December 2011

,
Interventionparticipants (Number)
Neonatal jaundiceNeonatal respiratory distress syndromeNeonatal hospitalization >3 daysIntrauterine growth restrictionNeonatal infectinMinor birth defectOther complicationCongenital anomalyNeonatal death
Arm A: Clomiphene Citrate1724120412
Arm B: Letrozole2774521541

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Number of Pregnancy

(NCT00719186)
Timeframe: as few as 5 months, up to 16 months

InterventionParticipants (Count of Participants)
Arm A: Clomiphene Citrate103
Arm B: Letrozole154

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Time to Ovulation With Each Protocol

We hypothesized that time to ovulation would be shorter with stair-step protocol vs. traditional. (NCT01008319)
Timeframe: 5 years

Interventiondays (Mean)
Traditional Administration31.1
Stair-Step Administration21.5

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Delivery Outcomes

Proportion of participants that delivered a baby based on which protocol they were randomized to. (NCT01008319)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Traditional Protocol21
Stair-Step Protocol21

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Time to Pregnancy

(NCT01044862)
Timeframe: Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks

Interventiondays (Mean)
Aromatase Inhibitors (AI)67.2
Clomiphene Citrate (CC)67.4
Follicle Stimulating Hormone (FSH)62.3

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Rate of Pregnancy Obtained

(NCT01044862)
Timeframe: Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks

Interventionparticipants (Number)
Aromatase Inhibitors (AI)85
Clomiphene Citrate (CC)106
Follicle Stimulating Hormone (FSH)140

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Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH.

(NCT01044862)
Timeframe: Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks

Interventionnumber of multiples (Number)
Aromatase Inhibitors (AI)9
Clomiphene Citrate (CC)8
Follicle Stimulating Hormone (FSH)34

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Live Birth Rate

(NCT01044862)
Timeframe: Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks

Interventionparticipants (Number)
Aromatase Inhibitors (AI)56
Clomiphene Citrate (CC)70
Follicle Stimulating Hormone (FSH)97

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Change in HbA1C

The change in HbA1c from Baseline to 3 Months for each treatment arm (NCT01191320)
Timeframe: 3 months

InterventionRatio (Mean)
Placebo0
Androxal 12.5 mg0
Androxal 25 mg0

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Change in FSH After 3 Months of Treatment

(NCT01270841)
Timeframe: 3 months

InterventionmIU/mL (Mean)
Placebo-0.2
Testim (Topical Testosterone)-4.4
Androxal 12.5 mg5.1
Androxal 25 mg7.4

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Change in Luteinizing Hormone Levels

Changes in values from baseline in LH at month 3 (NCT01270841)
Timeframe: 3 months

InterventionmIU/mL (Mean)
Placebo-0.1
Testim (Topical Testosterone)-2.4
Androxal 12.5 mg4.8
Androxal 25 mg6.9

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Change in Total Morning Testosterone

Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim (NCT01270841)
Timeframe: 3 months

Interventionng/dL (Mean)
Placebo-16.9
Testim (Topical Testosterone)253.7
Androxal 12.5 mg258.5
Androxal 25 mg197.3

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Reproductive Safety

Change from baseline in sperm concentration (NCT01270841)
Timeframe: 3 months

Interventionmillions/mL (Mean)
Placebo-19.1
Testim (Topical Testosterone)-29.5
Androxal 12.5 mg8.2
Androxal 25 mg-2.8

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Luteal Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment

To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting. (NCT01291056)
Timeframe: 1 year

Interventionunits on a scale (Median)
Clomiphene Citrate5
Placebo2

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Luteal Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment

To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting. (NCT01291056)
Timeframe: 1 year

Interventionunits on a scale (Median)
Clomiphene Citrate9
Placebo9

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Follicular Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment

To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting. (NCT01291056)
Timeframe: 1 Year

Interventionunits on a scale (Median)
Clomiphene Citrate10
Placebo8

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Follicular Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment

To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting. (NCT01291056)
Timeframe: 1 year

Interventionunits on a scale (Median)
Clomiphene Citrate3
Placebo5

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Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.

The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24). (NCT01386606)
Timeframe: Week 6

Interventionng*h/mL (Mean)
Androxal 6.25 mg21.200
Androxal 12.5 mg34.012
Androxal 25 mg150.51

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Change in Leuteinizing Hormone (LH)

Changes in morning LH after continuous dosing (NCT01386606)
Timeframe: Baseline, Week 2, Week 4, Week 6

,,,
InterventionmIU/mL (Mean)
Morning LH at BaselineMorning LH at Week 2Morning LH Change from Baseline at Week 2Morning LH at Week 4Morning LH Change from Baseline at Week 4Morning LH at Week 6Morning LH Change from Baseline at Week 6
AndroGel3.572.00-1.571.88-1.692.2-1.41
Androxal 12.5 mg4.828.603.787.202.388.23.39
Androxal 25 mg4.989.644.6611.786.7914.59.51
Androxal 6.25 mg3.635.491.996.923.436.12.60

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Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.

The Cmax for plasma concentration. (NCT01386606)
Timeframe: Week 6

Interventionng/mL (Mean)
Androxal 6.25 mg1.8154
Androxal 12.5 mg3.3899
Androxal 25 mg16.2993

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Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.

The Tmax for plasma concentration. (NCT01386606)
Timeframe: Week 6

Interventionh (Mean)
Androxal 6.25 mg2.33
Androxal 12.5 mg2.42
Androxal 25 mg2.41

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Morning Testosterone Correlated With Serial Testosterone.

"9 AM morning testosterone correlated with Week 6 serial testosterone Cavg, Cmin, and Cmax.~If a subject did not have a Week 6 serial testosterone Cavg, Cmin, or Cmax then they were not included for that particular correlation calculation." (NCT01386606)
Timeframe: Week 6

InterventionNumber of Subjects (Number)
Androxal Pooled Dose Levels35

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24 Hour Average and Maximum Testosterone Concentration

"The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment.~Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24." (NCT01386606)
Timeframe: Baseline and Week 6

,,,
Interventionng/dL (Mean)
TTavg at BaselineTTavg at Week 6TTmax at BaselineTTmax at Week 6
AndroGel322.4543.9562.3930.1
Androxal 12.5 mg373.6460.8513.7607.5
Androxal 25 mg298.3586.7425.9764.3
Androxal 6.25 mg262.3392.4358.5524.5

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Change in Follicle Stimulating Hormone (FSH)

Changes in morning FSH after continuous dosing (NCT01386606)
Timeframe: Baseline, Week 2, Week 4, Week 6

,,,
InterventionmIU/mL (Mean)
Morning FSH at BaselineMorning FSH at Week 2Morning FSH Change from Baseline at Week 2Morning FSH at Week 4Morning FSH Change from Baseline at Week 4Morning FSH at Week 6Morning FSH Change from Baseline at Week 6
AndroGel6.383.80-2.583.72-2.663.35-3.03
Androxal 12.5 mg5.637.772.147.121.488.192.56
Androxal 25 mg6.3111.415.0912.346.0313.457.14
Androxal 6.25 mg4.616.181.606.451.665.691.42

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Subjects With 50% or Greater Decrease in Sperm Concentration Comparison of Proportion of Subjects With 50% or Greater Decrease in Sperm

"Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo.~The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations." (NCT01532414)
Timeframe: 3 months

Interventionpercentage of participants (Number)
Androxal Subjects Pooled14.2
Placebo2.6

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Proportion (Percentage) of Androxal Treated Subjects With Testosterone in the Normal Range

"Proportion of pooled Androxal subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment. Cavg will be calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing.~If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the co-primary endpoint based on the Cavg for testosterone has been achieved.~FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment was not calculated." (NCT01532414)
Timeframe: 3 months

InterventionPercentage of Subjects (Number)
Androxal Treated Subjects Pooled78.8

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Change From Baseline in LH

Mean change from baseline in LH at end of treatment (26 weeks) (NCT01534208)
Timeframe: 6 months

InterventionmIu/mL (Mean)
Androxal 12.5 mg4.81
Androxal 25 mg4.27

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Absolute Values of Morning Testosterone

Absolute values of morning testosterone at end of treatment (26 weeks) (NCT01534208)
Timeframe: 6 months

Interventionng/dL (Mean)
Androxal 12.5 mg511.6
Androxal 25 mg416.7

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Change From Baseline in BMI

Mean change from baseline in BMI at end of treatment (26 weeks) (NCT01534208)
Timeframe: 6 months

Interventionkg/m2 (Mean)
Androxal 12.5 mg0.2
Androxal 25 mg0.3

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Change From Baseline in FSH

Change from baseline in FSH at end of treatment (26 weeks) (NCT01534208)
Timeframe: 6 months

InterventionU/L (Mean)
Androxal 12.5 mg5.20
Androxal 25 mg5.42

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Mean Change From Baseline FPG

Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks) (NCT01534208)
Timeframe: 6 months

Interventionmg/dL (Mean)
Androxal 12.5 mg-5.4
Androxal 25 mg-5.0

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Change From Baseline in Total Morning Testosterone at 26 Weeks

Changes in values from baseline of total morning testosterone levels at Week 26 (NCT01534208)
Timeframe: 6 months

Interventionng/dL (Mean)
Androxal 12.5 mg280.9
Androxal 25 mg214.7

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Change in Sperm Concentration

"Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo.~The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations." (NCT01739595)
Timeframe: 3 months

Interventionpercentage of subjects (Number)
Androxal Subjects Pooled14.2
Placebo4.3

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Subjects With Testosterone in Normal Range After Treatment

"Proportion (percent) of subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment. Cavg was calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing.~If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the coprimary endpoint based on the Cavg for testosterone would have been achieved.~FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment was not calculated." (NCT01739595)
Timeframe: 3 months

InterventionPercentage of Subjects (Number)
Androxal Subjects Pooled81.3

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Sexual Health Inventory for Men (SHIM) Questionnaire

Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 1, maximum score is 25. The minimum value is most symptomatic and maximum value is least symptomatic. (NCT01880086)
Timeframe: 3 months post initial visit

Interventionscores on a scale (Mean)
Clomiphene Citrate12.2
Placebo18.5

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Androgen Deficiency in the Aging Male (ADAM) Questionnaire

Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 0 and maximum score is 10. 0 is most symptomatic, and 10 is least symptomatic. (NCT01880086)
Timeframe: 3 months post initial visit

Interventionscores on a scale (Mean)
Clomiphene Citrate8.0
Placebo8.0

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Estradiol

(NCT01880086)
Timeframe: 3 months post initial visit

Interventionpg/mL (Mean)
Clomiphene Citrate23
Placebo25.2

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Hematocrit (%)

Measure hematocrit from baseline. (NCT01880086)
Timeframe: 3 months post initial visit

Interventionpercentage (Mean)
Clomiphene Citrate35.2
Placebo42.3

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Men's Sexual Health Questionnaire (MSHQ) Questionnaire

Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 1, maximum score is 20. Minimum score is considered most symptomatic, maximum score is considered least symptomatic. (NCT01880086)
Timeframe: 3 months post initial visit

Interventionscores on a scale (Mean)
Clomiphene Citrate7.0
Placebo8.8

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Other Hormonal Profile (Change From Baseline)

Luteinizing hormone (LH) (NCT01880086)
Timeframe: 3 months post initial visit

InterventionIU/mL (Mean)
Clomiphene Citrate3.3
Placebo2.2

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Serum Total Testosterone (Change From Baseline)

Morning venipuncture of serum total testosterone. (NCT01880086)
Timeframe: 3 months post initial visit

Interventionng/mL (Mean)
Clomiphene Citrate322.5
Placebo179.8

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Safety of Pioglitazone as Regards Serum Creatinine

serum creatinine was measured at the end of the study period (after 3 months) in both groups. (NCT01909141)
Timeframe: 3 months

Interventionmg/dL (Mean)
Arm 1:Letrozole-pioglitazone -Metformin Group0.62
Arm 2: Clomiphene Citrate-pioglitazone-metformin0.57

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Endometrial Thickness

(NCT01909141)
Timeframe: 3 months

Interventionmm (Mean)
Arm 1:Letrozole-pioglitazone -Metformin Group10.56
Arm 2: Clomiphene Citrate-pioglitazone-metformin9.68

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Number of Follicles>18mm.

(NCT01909141)
Timeframe: 3 months

Interventionfollicles (Mean)
Arm 1:Letrozole-pioglitazone -Metformin Group1.44
Arm 2: Clomiphene Citrate-pioglitazone-metformin1.5

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Ovulation Rate

(NCT01909141)
Timeframe: 3 months

Interventionpercentage of all cycles (Number)
Arm 1:Letrozole-pioglitazone -Metformin Group93
Arm 2: Clomiphene Citrate-pioglitazone-metformin108

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Pregnancy Rate

(NCT01909141)
Timeframe: 3 months

Interventionparticipants (Number)
Arm 1:Letrozole-pioglitazone -Metformin Group28
Arm 2: Clomiphene Citrate-pioglitazone-metformin24

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Number of Oocytes Vitrified

(NCT01921166)
Timeframe: up to 24 months

Interventionoocytes (Number)
Clomiphene Plus Gonadotropins19
Leuprolide Flare47

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Oocytes

Number of oocytes retrieved (NCT01921166)
Timeframe: up to 24 months

Interventionoocytes (Number)
Clomiphene Plus Gonadotropins19
Leuprolide Flare47

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Cmax of a Single Dose of 250 mg Androxal

(NCT01959685)
Timeframe: 24 hours

Interventionng/dL (Mean)
Up to 250 mg Androxal24.9

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Pharmacokinetics

Cmax of a single dose 125 mg of Androxal (NCT01959685)
Timeframe: 24 hrs

Interventionng/dL (Mean)
Up to 250 mg Androxal11.0

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Androxal Cmax Formulation B

To determine and compare the PK parameter Cmax between two formulations of Androxal (NCT01984398)
Timeframe: 24 hours

Interventionng/mL (Mean)
12.5 mg Androxal Formulation B1.08
25 mg Androxal Formulation B1.74

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Androxal Cmax Formulation A

To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal (NCT01984398)
Timeframe: 24 hours

Interventionng/mL (Mean)
12.5 mg Androxal Formulation A0.999
25 mg Androxal Formulation A1.67

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IGF-1 Levels

The objective is to compare the change of IGF-1 value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90). (NCT02274311)
Timeframe: Day 90

Interventionng/mL (Mean)
Clomiphene Citrate424

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PSA Levels

The objective is to compare the change of PSA value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90). (NCT02274311)
Timeframe: Day 90

Interventionng/mL (Median)
Clomiphene Citrate2.0

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Testosterone Levels

The objective is to compare the change of testosterone value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90). (NCT02274311)
Timeframe: D90

Interventionng/dL (Median)
Clomiphene Citrate282

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Number of Pregnancies Achieved Per Menstrual Cycle.

(NCT02294773)
Timeframe: Up to 3 months

Interventionpregnancies per cycle (Number)
Insemination Day Of Positive OPK0
Insemination Day After Positive OPK0

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Pregnancy Rate Per Semen Morphology Score

Comparison of pregnancy rate based on semen morphology of <4% vs >4% normal morphology scores. (NCT02294773)
Timeframe: Up to cycle day 35

,
Interventionpregnancies per cycle (Number)
Semen morphology < 4%Semen morphology > 4%
Insemination Day After Positive OPK00
Insemination Day Of Positive OPK00

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Pregnancy Rate Per Female Partner Age

Pregnancy rate will be compared between patients <35 and >35 at time of study entry. (NCT02294773)
Timeframe: Up to cycle day 35

,
Interventionpregnancies per cycle (Number)
Female age < 35Female age > 35
Insemination Day After Positive OPK00
Insemination Day Of Positive OPK00

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Pregnancy Rate Per Body Mass Index Category

(NCT02294773)
Timeframe: Up to cycle day 35

,
Interventionpregnancies per cycle (Number)
Body mass index normalBody mass index overweightBody mass index obese
Insemination Day After Positive OPK000
Insemination Day Of Positive OPK000

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Per Cycle Pregnancy Rate Based on Infertility Diagnosis

(NCT02294773)
Timeframe: Up to cycle day 35

Interventionpregnancies per cycle (Number)
Insemination Day Of Positive OPK0
Insemination Day After Positive OPK0

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Change From Baseline in Blood Testosterone (T) Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter T. A positive change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionng/dL (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg243.56173.81
Enclomiphene 25 mg218.24237.17
Placebo223.5343.33

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Change From Baseline in Homeostatic Model of Assessment - Insulin Resistance (HOMA-IR) at Week 48

The HOMA-IR is the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/mL) × fasting plasma glucose (mmol/L)/22.5. A negative change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg4.88-1.14
Enclomiphene 25 mg4.99-0.75
Placebo4.74-1.80

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Change From Baseline in Lean Body Mass (LBM) at Week 48

LBM was assessed using dual-energy X-ray absorptiometry (DXA). A positive change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionkg (Mean)
BaselineChange from Baseline to week 48
Enclomiphene 12.5 mg65.233.14
Enclomiphene 25 mg65.602.40
Placebo68.121.05

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Change From Baseline in Ratio of Dihydrotestosterone: Testosterone (DHT:T) at Week 48

The DHT:T ratio was calculated as the value of DHT/value of T using the same units. A negative change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionratio (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg0.080.01
Enclomiphene 25 mg0.080.00
Placebo0.070.00

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Change From Baseline in Ratio of Testosterone: Estradiol (T:E2) at Week 48

The T:E2 ratio was calculated as the value of T/value of E2 using the same units. A positive change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionratio (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg5.265.11
Enclomiphene 25 mg4.932.89
Placebo5.212.85

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Change From Baseline in Waist Circumference at Week 48

A negative change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventioncm (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg115.34-6.71
Enclomiphene 25 mg120.87-6.52
Placebo123.96-12.62

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Change From Baseline in Weight at Week 48

A negative change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionkg (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg114.13-4.36
Enclomiphene 25 mg121.75-6.15
Placebo124.58-14.51

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Change From Baseline in Blood Dihydrotestosterone (DHT) Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter DHT. A positive change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionnanogram per deciliter (ng/dL) (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg18.7815.13
Enclomiphene 25 mg16.0620.75
Placebo15.734.25

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Change From Baseline in Blood Estradiol (E2) Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter E2. A positive change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionpg/mL (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg50.04-3.00
Enclomiphene 25 mg48.4313.03
Placebo45.49-11.46

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Change From Baseline in Blood Glucose Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter Glucose. A negative change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionpg/mL (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg98.39-1.81
Enclomiphene 25 mg101.41-5.25
Placebo97.93-4.33

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Change From Baseline in Blood Interleukin-6 (IL-6) Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter IL-6. A negative change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionpg/mL (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg2.230.56
Enclomiphene 25 mg3.38-0.21
Placebo2.75-0.78

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Change From Baseline in Blood Leptin Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter leptin. A negative change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionng/mL (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg9.881.14
Enclomiphene 25 mg16.552.63
Placebo15.16-2.27

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Change From Baseline in Blood Luteinizing Hormone (LH) Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter LH measured in milli-International Units per milliliter (mIU/mL). A positive change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
InterventionmIU/mL (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg3.932.40
Enclomiphene 25 mg3.413.01
Placebo3.510.83

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Change From Baseline in Blood Quantose-Insulin Resistance (IR) Score at Week 48

Quantose-IR is a laboratory-developed test that assesses insulin resistance. Quantose-IR score is based on a linear regression algorithm utilizing the quantitative measures (natural log transformed) of alpha-hydroxybutyrate, oleate, linoleoylglycerophosphocholine and insulin and was designed to estimate the natural log of insulin-induced glucose infusion rate normalized by whole body mass. The algorithm score is converted to the Quantose-IR score within a range of 1-120 by an arithmetic calculation where higher scores denote greater insulin resistance. A negative change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
InterventionQuantose-IR score (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg75.74-3.96
Enclomiphene 25 mg76.50-6.59
Placebo78.05-6.50

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Change From Baseline in Blood C-reactive Protein (CRP) Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter CRP. A negative change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionmg/dL (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg0.250.06
Enclomiphene 25 mg0.35-0.05
Placebo0.35-0.15

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Change From Baseline in Blood Tumor Necrosis Factor Alpha (TNF-α) Level at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter TNF-α . A negative change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionpg/mL (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg1.77-0.63
Enclomiphene 25 mg1.93-0.35
Placebo1.94-0.70

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Change From Baseline in Body Mass Index (BMI) at Week 48

BMI is calculated as weight (kg)/height(cm^2). A negative change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionkg/cm^2 (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg35.45-1.43
Enclomiphene 25 mg37.38-2.29
Placebo38.05-4.38

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Change From Baseline in Body Strength (Chest Press Weight) at Week 48

Body strength was assessed from maximum chest and leg press weight achieved, using an inclined plane leg press and vertical chest press. A positive change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionpounds (lbs) (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg169.0075.00
Enclomiphene 25 mg180.9376.90
Placebo151.5087.27

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Change From Baseline in Body Strength (Leg Press Weight) at Week 48

Body strength was assessed from maximum chest and leg press weight achieved, using an inclined plane leg press and vertical chest press. A positive change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionpounds (lbs) (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg466.06406.92
Enclomiphene 25 mg464.20323.80
Placebo580.86351.50

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Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 48

A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter HbA1c. A negative change from Baseline indicates improvement. (NCT02651688)
Timeframe: Baseline (Day 0) to Week 48

,,
Interventionpercentage of HbA1c (Mean)
BaselineChange from Baseline to Week 48
Enclomiphene 12.5 mg5.56-0.34
Enclomiphene 25 mg5.95-0.54
Placebo5.77-0.65

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Clinical Pregnancy Rate

Identifying pregnancy through positive urinary HCG test plus sonographic detection of cardiac pulsations (NCT02710981)
Timeframe: At the end of a 28-day menstrual cycle.

InterventionParticipants (Count of Participants)
Clomiphene Citrate Only Group (6th Ovulation Induction Cycle)0
Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation3

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Uterine Blood Flow

Doppler ultrasound is used to measure the pulsatility index in both uterine arteries. Pulsatility index is a measure of the arterial resistance to blood flow. The higher the value of the pulsatility index, the more resistant the uterine arteries are, and hence the worst the outcome. (NCT02710981)
Timeframe: Day of HCG administration

Interventionindex (Mean)
Clomiphene Citrate Only Group (6th Ovulation Induction Cycle)2.4
Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation)1.6

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Endometrial Thickness

Transvaginal sonographic measurement of maximal distance spanning endometrial- myometrial interphase on each endometrial stripe in a sagittal plane in the fundus of the uterus (NCT02710981)
Timeframe: Day of HCG administration

Interventionmillimeter (Mean)
Clomiphene Citrate Only Group (6th Ovulation Induction Cycle)6.6
Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation)9.3

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Number of Developing Follicles

Number of follicles measuring > 10mm on ultrasound (NCT02802865)
Timeframe: Cycle day 12-14

Interventionfollicles (Median)
Letrozole0
Letrozole + Clomiphene1

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Multiple Gestation

Multiple Gestation: an intrauterine pregnancy with multiple fetal heart rates determined by ultrasonography; No Multiple Gestation: either no intrauterine pregnancy, or an intrauterine pregnancy with a single fetal heart rate determined by ultrasonography (NCT02802865)
Timeframe: 9-10 months after treatment

InterventionParticipants (Count of Participants)
Letrozole0
Letrozole + Clomiphene0

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Live Birth

Live Birth: delivery of a live infant; No Live Birth: no delivery of a live infant (NCT02802865)
Timeframe: 9-10 months after treatment

InterventionParticipants (Count of Participants)
Letrozole1
Letrozole + Clomiphene3

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Endometrial Thickness

Thickness of endometrial lining assessed by ultrasound (NCT02802865)
Timeframe: Cycle day 12-14

Interventionmm (Mean)
Letrozole6.2
Letrozole + Clomiphene8.3

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Conception

Conception: a positive serum or urinary test of hCG; No conception: Neither a positive serum or urinary test of hCG (NCT02802865)
Timeframe: 5 weeks after treatment

InterventionParticipants (Count of Participants)
Letrozole3
Letrozole + Clomiphene4

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Size of Largest Developing Follicle

Size of largest follicle on ultrasound (NCT02802865)
Timeframe: Cycle day 12-14

Interventionmm (Median)
Letrozole10
Letrozole + Clomiphene16

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Pregnancy Loss

Pregnancy Loss: any pregnancy loss including biochemical pregnancy, ectopic pregnancy, and miscarriage; No Pregnancy Loss: no pregnancy loss including biochemical pregnancy, ectopic pregnancy, or miscarriage. (NCT02802865)
Timeframe: 9-10 months after treatment

InterventionParticipants (Count of Participants)
Letrozole2
Letrozole + Clomiphene1

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Number of Participants Achieving Ovulation Measured by Mid-luteal Progesterone Level

Ovulation: mid-luteal progesterone > /=3 ng/mL. No ovulation: mid-luteal progesterone <3ng/mL. (NCT02802865)
Timeframe: 7 days following LH surge or at cycle day 21 if no LH surge was detected

InterventionParticipants (Count of Participants)
Letrozole15
Letrozole + Clomiphene27

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Clinical Pregnancy

Clinical Pregnancy: an intrauterine pregnancy with fetal heart motion determined by ultrasonography; No Clinical Pregnancy: no intrauterine pregnancy with fetal heart motion determined by ultrasonography (NCT02802865)
Timeframe: 6-7 weeks after treatment

InterventionParticipants (Count of Participants)
Letrozole1
Letrozole + Clomiphene3

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Serum Free Testosterone

after clomiphene or placebo treatment (NCT03245827)
Timeframe: 12 weeks

Interventionpg/ml (Mean)
Obese Males With Hypogonadism-active85

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ADAM (Androgen Deficiency in the Aging Male) Score - Week 24

"Self reported quantification of hypogonadism. 10 yes or no questions.~A positive (yes) questionnaire result is defined as a yes or 1 and a negative (no) questionnaire result is defined as a no or 0 to question 1 or question 7 or any 3 other questions.~Yes (1) represents a better outcome than No (1)~In Data Entry:~Yes - 1 No - 0" (NCT03933618)
Timeframe: Week 24

Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole011

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SEP #1-3 Cumulative - Week 8

"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0" (NCT03933618)
Timeframe: Week 8

Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18
Clomiphene-placebo-anastrazole121

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SEP #1-3 Cumulative - Week 8

"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0" (NCT03933618)
Timeframe: Week 8

,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 19-24
Anastrazole-clomiphene-placebo323
Clomiphene-anastrazole-placebo123

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SEP #1-3 Cumulative - Week 8

"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0" (NCT03933618)
Timeframe: Week 8

,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-placebo-clomiphene3323
Placebo-anastrazole-clomiphene4322

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SHBG - Screen

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 (NCT03933618)
Timeframe: Baseline

Interventionnmol/L (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole26.220.916.9

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SHBG - Screen

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 (NCT03933618)
Timeframe: Baseline

,,,,
Interventionnmol/L (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo13.930.723.528.6
Anastrazole-placebo-clomiphene35.212.617.522
Clomiphene-anastrazole-placebo2023.521.435.5
Clomiphene-placebo-anastrazole31.726.42011.6
Placebo-anastrazole-clomiphene24.126.814.830.6

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SHBG - Week 16

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 (NCT03933618)
Timeframe: Week 16

Interventionnmol/L (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole33.316.717.2

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SHBG - Week 16

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 (NCT03933618)
Timeframe: Week 16

,,,,
Interventionnmol/L (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo22.330.726.839.3
Anastrazole-placebo-clomiphene35.515.317.224.8
Clomiphene-anastrazole-placebo13.826.614.235
Clomiphene-placebo-anastrazole16.43122.813.9
Placebo-anastrazole-clomiphene17.72316.631

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SHBG - Week 24

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 (NCT03933618)
Timeframe: Week 24

,
Interventionnmol/L (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-anastrazole-clomiphene23.634.117.5
Placebo-clomiphene-anastrazole29.713.817.3

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SHBG - Week 24

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 (NCT03933618)
Timeframe: Week 24

Interventionnmol/L (Number)
Patients 1-6Patients 7-12Patients 19-24
Clomiphene-anastrazole-placebo15.124.433.8

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SHBG - Week 24

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 (NCT03933618)
Timeframe: Week 24

,,
Interventionnmol/L (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Clomiphene-placebo-anastrazole25.225.320.113.7
Anastrazole-placebo-clomiphene41.81621.726
Anastrazole-clomiphene-placebo14.633.82923.2

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SHBG - Week 8

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 (NCT03933618)
Timeframe: Week 8

Interventionnmol/L (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole23.924.114.3

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SHBG - Week 8

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 (NCT03933618)
Timeframe: Week 8

,,,,
Interventionnmol/L (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo1023.426.928.1
Anastrazole-placebo-clomiphene38.212.716.120.1
Clomiphene-anastrazole-placebo18.42621.642.7
Clomiphene-placebo-anastrazole29.827.230.920.9
Placebo-anastrazole-clomiphene21.625.717.630.7

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ADAM (Androgen Deficiency in the Aging Male) Score - Screen

"Self reported quantification of hypogonadism. 10 yes or no questions.~A positive (yes) questionnaire result is defined as a yes or 1 and a negative (no) questionnaire result is defined as a no or 0 to question 1 or question 7 or any 3 other questions.~Yes (1) represents a better outcome than No (1)~In Data Entry:~Yes - 1 No - 0" (NCT03933618)
Timeframe: Baseline

,,,,,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo1111
Anastrazole-placebo-clomiphene1111
Clomiphene-anastrazole-placebo1111
Clomiphene-placebo-anastrazole1111
Placebo-anastrazole-clomiphene1111
Placebo-clomiphene-anastrazole1111

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ADAM (Androgen Deficiency in the Aging Male) Score - Week 16

"Self reported quantification of hypogonadism. 10 yes or no questions.~A positive (yes) questionnaire result is defined as a yes or 1 and a negative (no) questionnaire result is defined as a no or 0 to question 1 or question 7 or any 3 other questions.~Yes (1) represents a better outcome than No (1)~In Data Entry:~Yes - 1 No - 0" (NCT03933618)
Timeframe: Week 16

Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole010

[back to top]

SEP #1-3 Cumulative - Week 8

"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0" (NCT03933618)
Timeframe: Week 8

Interventionscore on a scale (Number)
Patients 1-6Patients 19-24
Placebo-clomiphene-anastrazole31

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ADAM (Androgen Deficiency in the Aging Male) Score - Week 16

"Self reported quantification of hypogonadism. 10 yes or no questions.~A positive (yes) questionnaire result is defined as a yes or 1 and a negative (no) questionnaire result is defined as a no or 0 to question 1 or question 7 or any 3 other questions.~Yes (1) represents a better outcome than No (1)~In Data Entry:~Yes - 1 No - 0" (NCT03933618)
Timeframe: Week 16

,,,,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo1111
Anastrazole-placebo-clomiphene1111
Clomiphene-anastrazole-placebo1111
Clomiphene-placebo-anastrazole1101
Placebo-anastrazole-clomiphene1111

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ADAM (Androgen Deficiency in the Aging Male) Score - Week 24

"Self reported quantification of hypogonadism. 10 yes or no questions.~A positive (yes) questionnaire result is defined as a yes or 1 and a negative (no) questionnaire result is defined as a no or 0 to question 1 or question 7 or any 3 other questions.~Yes (1) represents a better outcome than No (1)~In Data Entry:~Yes - 1 No - 0" (NCT03933618)
Timeframe: Week 24

,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 19-24
Clomiphene-anastrazole-placebo011
Clomiphene-placebo-anastrazole110

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ADAM (Androgen Deficiency in the Aging Male) Score - Week 24

"Self reported quantification of hypogonadism. 10 yes or no questions.~A positive (yes) questionnaire result is defined as a yes or 1 and a negative (no) questionnaire result is defined as a no or 0 to question 1 or question 7 or any 3 other questions.~Yes (1) represents a better outcome than No (1)~In Data Entry:~Yes - 1 No - 0" (NCT03933618)
Timeframe: Week 24

,,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-placebo-clomiphene0101
Placebo-anastrazole-clomiphene1111
Anastrazole-clomiphene-placebo1101

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ADAM (Androgen Deficiency in the Aging Male) Score - Week 8

"Self reported quantification of hypogonadism. 10 yes or no questions.~A positive (yes) questionnaire result is defined as a yes or 1 and a negative (no) questionnaire result is defined as a no or 0 to question 1 or question 7 or any 3 other questions.~Yes (1) represents a better outcome than No (1)~In Data Entry:~Yes - 1 No - 0" (NCT03933618)
Timeframe: Week 8

Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18
Anastrazole-clomiphene-placebo111

[back to top]

ADAM (Androgen Deficiency in the Aging Male) Score - Week 8

"Self reported quantification of hypogonadism. 10 yes or no questions.~A positive (yes) questionnaire result is defined as a yes or 1 and a negative (no) questionnaire result is defined as a no or 0 to question 1 or question 7 or any 3 other questions.~Yes (1) represents a better outcome than No (1)~In Data Entry:~Yes - 1 No - 0" (NCT03933618)
Timeframe: Week 8

,,,,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-placebo-clomiphene1101
Clomiphene-anastrazole-placebo1011
Clomiphene-placebo-anastrazole1101
Placebo-anastrazole-clomiphene1111
Placebo-clomiphene-anastrazole1001

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EHS (Erectile Hardness Score) - Screen

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid (NCT03933618)
Timeframe: Baseline

,,,,,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo3333
Anastrazole-placebo-clomiphene3333
Clomiphene-anastrazole-placebo3333
Clomiphene-placebo-anastrazole2223
Placebo-anastrazole-clomiphene3333
Placebo-clomiphene-anastrazole3313

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EHS (Erectile Hardness Score) - Week 16

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid (NCT03933618)
Timeframe: Week 16

Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole421

[back to top]

EHS (Erectile Hardness Score) - Week 16

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid (NCT03933618)
Timeframe: Week 16

,,,,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo3333
Anastrazole-placebo-clomiphene3341
Clomiphene-anastrazole-placebo2333
Clomiphene-placebo-anastrazole2343
Placebo-anastrazole-clomiphene3301

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EHS (Erectile Hardness Score) - Week 24

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid (NCT03933618)
Timeframe: Week 24

Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole321

[back to top]

EHS (Erectile Hardness Score) - Week 24

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid (NCT03933618)
Timeframe: Week 24

Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 19-24
Clomiphene-anastrazole-placebo233

[back to top]

EHS (Erectile Hardness Score) - Week 24

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid (NCT03933618)
Timeframe: Week 24

,,,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo3333
Anastrazole-placebo-clomiphene4341
Clomiphene-placebo-anastrazole2243
Placebo-anastrazole-clomiphene3311

[back to top]

EHS (Erectile Hardness Score) - Week 8

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid (NCT03933618)
Timeframe: Week 8

,,,,,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo1333
Anastrazole-placebo-clomiphene4333
Clomiphene-anastrazole-placebo1333
Clomiphene-placebo-anastrazole1232
Placebo-anastrazole-clomiphene1233
Placebo-clomiphene-anastrazole3411

[back to top]

Estradiol - Screen

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 (NCT03933618)
Timeframe: Baseline

Interventionpg/mL (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole15.918.615.9

[back to top]

Estradiol - Screen

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 (NCT03933618)
Timeframe: Baseline

,,,,
Interventionpg/mL (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo21.6913.39.5
Anastrazole-placebo-clomiphene8.119.320.115.5
Clomiphene-anastrazole-placebo9.621.316.226.6
Clomiphene-placebo-anastrazole13.511.414.111
Placebo-anastrazole-clomiphene18.410.913.126.8

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Estradiol - Week 16

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 (NCT03933618)
Timeframe: Week 16

Interventionpg/mL (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole56.928.237

[back to top]

Estradiol - Week 16

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 (NCT03933618)
Timeframe: Week 16

Interventionpg/mL (Number)
Patients 7-12Patients 13-18Patients 19-24
Anastrazole-placebo-clomiphene21.61528.3

[back to top]

Estradiol - Week 16

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 (NCT03933618)
Timeframe: Week 16

,,,
Interventionpg/mL (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo39.513.120.148.5
Clomiphene-anastrazole-placebo8.912.823.814.8
Clomiphene-placebo-anastrazole17.914.413.115.9
Placebo-anastrazole-clomiphene56.84.94.9

[back to top]

Estradiol - Week 24

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 (NCT03933618)
Timeframe: Week 24

,
Interventionpg/mL (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-anastrazole-clomiphene41.185.929.3
Placebo-clomiphene-anastrazole18.111.64.9

[back to top]

Estradiol - Week 24

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 (NCT03933618)
Timeframe: Week 24

Interventionpg/mL (Number)
Patients 1-6Patients 7-12Patients 19-24
Clomiphene-anastrazole-placebo16.26.619

[back to top]

Estradiol - Week 24

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 (NCT03933618)
Timeframe: Week 24

,,
Interventionpg/mL (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo22.512.525.522.2
Anastrazole-placebo-clomiphene43.949.136.439.4
Clomiphene-placebo-anastrazole9.559.24.9

[back to top]

Estradiol - Week 8

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 (NCT03933618)
Timeframe: Week 8

Interventionpg/mL (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole20.818.510

[back to top]

Estradiol - Week 8

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 (NCT03933618)
Timeframe: Week 8

Interventionpg/mL (Number)
Patients 7-12Patients 13-18Patients 19-24
Anastrazole-placebo-clomiphene15.14.910.7

[back to top]

Estradiol - Week 8

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 (NCT03933618)
Timeframe: Week 8

,,,
Interventionpg/mL (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo11.279.77.4
Clomiphene-anastrazole-placebo49.870.125.151.7
Clomiphene-placebo-anastrazole94.54533.539.1
Placebo-anastrazole-clomiphene22.59.315.927.4

[back to top]

Free Testosterone - Screen

Measure of Free Testosterone (NCT03933618)
Timeframe: Baseline

Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole6.275.829.49

[back to top]

Free Testosterone - Screen

Measure of Free Testosterone (NCT03933618)
Timeframe: Baseline

,
Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 19-24
Clomiphene-anastrazole-placebo7.286.076.52
Placebo-anastrazole-clomiphene7.865.786.33

[back to top]

Free Testosterone - Screen

Measure of Free Testosterone (NCT03933618)
Timeframe: Baseline

,,
Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo8.46.749.562.19
Anastrazole-placebo-clomiphene6.999.3112.277.27
Clomiphene-placebo-anastrazole8.829.94.867.71

[back to top]

Free Testosterone - Week 16

Measure of Free Testosterone (NCT03933618)
Timeframe: Week 16

,
Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18
Clomiphene-placebo-anastrazole12.679.636.63
Placebo-clomiphene-anastrazole19.2114.5716.38

[back to top]

Free Testosterone - Week 16

Measure of Free Testosterone (NCT03933618)
Timeframe: Week 16

Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 19-24
Clomiphene-anastrazole-placebo12.2714.711.22

[back to top]

Free Testosterone - Week 16

Measure of Free Testosterone (NCT03933618)
Timeframe: Week 16

,,
Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo14.168.8310.1714.98
Anastrazole-placebo-clomiphene16.375.75.989.46
Placebo-anastrazole-clomiphene17.4713.477.5811.62

[back to top]

Free Testosterone - Week 24

Measure of Free Testosterone (NCT03933618)
Timeframe: Week 24

Interventionng/dl (Number)
Patients 1-6Patients 7-12
Placebo-anastrazole-clomiphene19.3125.27

[back to top]

Free Testosterone - Week 24

Measure of Free Testosterone (NCT03933618)
Timeframe: Week 24

Interventionng/dl (Number)
Patients 1-6Patients 13-18Patients 19-24
Anastrazole-placebo-clomiphene19.3513.7413.54

[back to top]

Free Testosterone - Week 24

Measure of Free Testosterone (NCT03933618)
Timeframe: Week 24

Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole8.6511.6315.49

[back to top]

Free Testosterone - Week 24

Measure of Free Testosterone (NCT03933618)
Timeframe: Week 24

Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 19-24
Clomiphene-anastrazole-placebo6.2511.096.11

[back to top]

Free Testosterone - Week 24

Measure of Free Testosterone (NCT03933618)
Timeframe: Week 24

,
Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo10.516.1111.825.82
Clomiphene-placebo-anastrazole11.2817.8918.1916.82

[back to top]

Free Testosterone - Week 8

Measure of Free Testosterone (NCT03933618)
Timeframe: Week 8

Interventionng/dl (Number)
Patients 1-6Patients 13-18Patients 19-24
Anastrazole-placebo-clomiphene21.815.1820.01

[back to top]

Free Testosterone - Week 8

Measure of Free Testosterone (NCT03933618)
Timeframe: Week 8

Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole2.719.48.91

[back to top]

Free Testosterone - Week 8

Measure of Free Testosterone (NCT03933618)
Timeframe: Week 8

,
Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 19-24
Clomiphene-anastrazole-placebo17.7219.3311.37
Placebo-anastrazole-clomiphene12.35.36.04

[back to top]

Free Testosterone - Week 8

Measure of Free Testosterone (NCT03933618)
Timeframe: Week 8

,
Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo19.4615.6321.6117.44
Clomiphene-placebo-anastrazole35.2727.7921.7115.71

[back to top]

FSH - Screen

Lab Values for follicle stimulating hormone (NCT03933618)
Timeframe: Baseline

InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole3.31.84.4

[back to top]

FSH - Screen

Lab Values for follicle stimulating hormone (NCT03933618)
Timeframe: Baseline

,,,,
InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo2.75.71.65.5
Anastrazole-placebo-clomiphene2.43.75.110
Clomiphene-anastrazole-placebo5.53.91.74.5
Clomiphene-placebo-anastrazole4.52.944.4
Placebo-anastrazole-clomiphene3.63.55.75.1

[back to top]

FSH - Week 16

Lab Values for follicle stimulating hormone (NCT03933618)
Timeframe: Week 16

InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole10.72.68.3

[back to top]

FSH - Week 16

Lab Values for follicle stimulating hormone (NCT03933618)
Timeframe: Week 16

,,,,
InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-placebo-clomiphene4.33.73.811.4
Clomiphene-anastrazole-placebo4.261.26.2
Clomiphene-placebo-anastrazole5.32.93.34.2
Placebo-anastrazole-clomiphene6.86.511.58.9
Anastrazole-clomiphene-placebo77.21.912.8

[back to top]

FSH - Week 24

Lab Values for follicle stimulating hormone (NCT03933618)
Timeframe: Week 24

,
InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-anastrazole-clomiphene414.510.4
Placebo-clomiphene-anastrazole6.55.25.9

[back to top]

FSH - Week 24

Lab Values for follicle stimulating hormone (NCT03933618)
Timeframe: Week 24

InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 19-24
Clomiphene-anastrazole-placebo365

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FSH - Week 24

Lab Values for follicle stimulating hormone (NCT03933618)
Timeframe: Week 24

,,
InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo4.14.424.8
Anastrazole-placebo-clomiphene4.815.17.229.7
Clomiphene-placebo-anastrazole5.23.77.25.8

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FSH - Week 8

Lab Values for follicle stimulating hormone (NCT03933618)
Timeframe: Week 8

InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole3.42.24.7

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FSH - Week 8

Lab Values for follicle stimulating hormone (NCT03933618)
Timeframe: Week 8

,,,,
InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo5.47.7311.3
Anastrazole-placebo-clomiphene4.36.28.320.3
Clomiphene-anastrazole-placebo8.27.81.86.1
Clomiphene-placebo-anastrazole16.23.036.38.1
Placebo-anastrazole-clomiphene4.14.264.4

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IIEF (International Index of Erectile Function) Score - Screen

15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 (NCT03933618)
Timeframe: At baseline

,,,,,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo34575550
Anastrazole-placebo-clomiphene43574652
Clomiphene-anastrazole-placebo57454155
Clomiphene-placebo-anastrazole41324547
Placebo-anastrazole-clomiphene24553262
Placebo-clomiphene-anastrazole57365818

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IIEF (International Index of Erectile Function) Score - Week 16

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 (NCT03933618)
Timeframe: Week 16

Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole663359

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IIEF (International Index of Erectile Function) Score - Week 16

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 (NCT03933618)
Timeframe: Week 16

,,,,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo45435362
Anastrazole-placebo-clomiphene53566238
Clomiphene-anastrazole-placebo35503751
Clomiphene-placebo-anastrazole45555847
Placebo-anastrazole-clomiphene37381518

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IIEF (International Index of Erectile Function) Score - Week 24

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 (NCT03933618)
Timeframe: Week 24

Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole652745

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IIEF (International Index of Erectile Function) Score - Week 24

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 (NCT03933618)
Timeframe: Week 24

Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 19-24
Clomiphene-anastrazole-placebo424360

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IIEF (International Index of Erectile Function) Score - Week 8

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 (NCT03933618)
Timeframe: Week 8

,,,,,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo25455563
Anastrazole-placebo-clomiphene55515965
Clomiphene-anastrazole-placebo32633270
Clomiphene-placebo-anastrazole20456545
Placebo-anastrazole-clomiphene35372853
Placebo-clomiphene-anastrazole66724325

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IIEF (International Index of Erectile Function) Score - Week 24

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 (NCT03933618)
Timeframe: Week 24

,,,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo12546052
Clomiphene-placebo-anastrazole52357247
Placebo-anastrazole-clomiphene41451714
Anastrazole-placebo-clomiphene70606559

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LH - Screen

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. (NCT03933618)
Timeframe: Baseline

InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole3.52.46

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LH - Screen

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. (NCT03933618)
Timeframe: Baseline

,,,,
InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo3.53.41.16.3
Anastrazole-placebo-clomiphene3.63.83.54.1
Clomiphene-anastrazole-placebo3.82.44.14.7
Clomiphene-placebo-anastrazole6.84.13.35.9
Placebo-anastrazole-clomiphene3.41.73.16.8

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LH - Week 16

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. (NCT03933618)
Timeframe: Week 16

InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole13.95.213

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LH - Week 16

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. (NCT03933618)
Timeframe: Week 16

,,,,
InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo6.86.91.97.8
Anastrazole-placebo-clomiphene4.64.82.14.3
Clomiphene-anastrazole-placebo4.26.32.26.6
Clomiphene-placebo-anastrazole5.44.91.94.9
Placebo-anastrazole-clomiphene8.93.86.47.4

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LH - Week 24

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. (NCT03933618)
Timeframe: Week 24

,
InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-anastrazole-clomiphene7.710.58.1
Placebo-clomiphene-anastrazole52.97.1

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LH - Week 24

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. (NCT03933618)
Timeframe: Week 24

InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 19-24
Clomiphene-anastrazole-placebo3.45.94.7

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LH - Week 24

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. (NCT03933618)
Timeframe: Week 24

,,
InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo36.12.22.7
Anastrazole-placebo-clomiphene4.112.65.415.1
Clomiphene-placebo-anastrazole6.46.47.65.4

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LH - Week 8

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. (NCT03933618)
Timeframe: Week 8

InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole3.63.36.7

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LH - Week 8

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. (NCT03933618)
Timeframe: Week 8

,,,,
InterventionIU/L (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-placebo-clomiphene5.146.911.5
Clomiphene-anastrazole-placebo9.910.76.17.5
Clomiphene-placebo-anastrazole17.312.64.76.9
Placebo-anastrazole-clomiphene6.31.937.3
Anastrazole-clomiphene-placebo9.15.22.94.2

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Normalized Testosterone - Screen

Normalized at >350ng/dl (NCT03933618)
Timeframe: Baseline

Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole315214321

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Normalized Testosterone - Screen

Normalized at >350ng/dl (NCT03933618)
Timeframe: Baseline

,,,,
Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo20529334795
Anastrazole-placebo-clomiphene330237328291
Clomiphene-anastrazole-placebo226194268306
Clomiphene-placebo-anastrazole367300206244
Placebo-anastrazole-clomiphene321243148289

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Normalized Testosterone - Week 16

Normalized at >350ng/dl (NCT03933618)
Timeframe: Week 16

Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole696396585

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Normalized Testosterone - Week 16

Normalized at >350ng/dl (NCT03933618)
Timeframe: Week 16

,,,,
Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo437337329609
Anastrazole-placebo-clomiphene591200191323
Clomiphene-anastrazole-placebo338451124456
Clomiphene-placebo-anastrazole391403206288
Placebo-anastrazole-clomiphene502520283484

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Normalized Testosterone - Week 24

Normalized at >350ng/dl (NCT03933618)
Timeframe: Week 24

,
Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-anastrazole-clomiphene596972195
Placebo-clomiphene-anastrazole412375487

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Normalized Testosterone - Week 24

Normalized at >350ng/dl (NCT03933618)
Timeframe: Week 24

Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 19-24
Clomiphene-anastrazole-placebo214440274

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Normalized Testosterone - Week 24

Normalized at >350ng/dl (NCT03933618)
Timeframe: Week 24

,,
Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo268269446196
Anastrazole-placebo-clomiphene793519449630
Clomiphene-placebo-anastrazole537531447486

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Normalized Testosterone - Week 8

Normalized at >350ng/dl (NCT03933618)
Timeframe: Week 8

Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18
Placebo-clomiphene-anastrazole133271270

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Normalized Testosterone - Week 8

Normalized at >350ng/dl (NCT03933618)
Timeframe: Week 8

,,,,
Interventionng/dl (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo484387607545
Anastrazole-placebo-clomiphene757296453676
Clomiphene-anastrazole-placebo566693216592
Clomiphene-placebo-anastrazole1316917527497
Placebo-anastrazole-clomiphene470298139296

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SEP #1-3 Cumulative - Week 16

"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0" (NCT03933618)
Timeframe: Week 16

Interventionscore on a scale (Number)
Patients 13-18
Placebo-clomiphene-anastrazole3

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SEP #1-3 Cumulative - Week 16

"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0" (NCT03933618)
Timeframe: Week 16

Interventionscore on a scale (Number)
Patients 7-12Patients 19-24
Clomiphene-anastrazole-placebo33

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SEP #1-3 Cumulative - Week 16

"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0" (NCT03933618)
Timeframe: Week 16

,,,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-clomiphene-placebo2343
Clomiphene-placebo-anastrazole1333
Placebo-anastrazole-clomiphene2021
Anastrazole-placebo-clomiphene3333

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SEP #1-3 Cumulative - Week 24

"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0" (NCT03933618)
Timeframe: Week 24

Interventionscore on a scale (Number)
Patients 1-6Patients 13-18
Placebo-clomiphene-anastrazole30

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SEP #1-3 Cumulative - Week 24

"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0" (NCT03933618)
Timeframe: Week 24

,
Interventionscore on a scale (Number)
Patients 7-12Patients 19-24
Anastrazole-clomiphene-placebo33
Clomiphene-anastrazole-placebo33

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SEP #1-3 Cumulative - Week 24

"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0" (NCT03933618)
Timeframe: Week 24

Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18
Clomiphene-placebo-anastrazole312

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SEP #1-3 Cumulative - Week 24

"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0" (NCT03933618)
Timeframe: Week 24

,
Interventionscore on a scale (Number)
Patients 1-6Patients 7-12Patients 13-18Patients 19-24
Anastrazole-placebo-clomiphene3333
Placebo-anastrazole-clomiphene2021

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Changes in Endometrial Thickness

Changes in endometrial thickness between the 3 groups. (NCT04177693)
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)

Interventionmm (Mean)
EGCG Daily Alone.-1.9
EGCG With Clomiphene Citrate1.4
EGCG With Letrozole0.6

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Changes in ALT/SGPT

Changes in alanine aminotransferase /SGPT between the 3 groups. (NCT04177693)
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)

InterventionU/L (Mean)
EGCG Daily Alone.1.1
EGCG With Clomiphene Citrate4.4
EGCG With Letrozole-1.0

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Changes in Alkaline Phosphatase

Changes in Alkaline Phosphatase between the 3 groups. (NCT04177693)
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)

InterventionU/L (Mean)
EGCG Daily Alone.-1.5
EGCG With Clomiphene Citrate-5.6
EGCG With Letrozole-6.0

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Change in Serum Folate Level Between MTHFR677-Wild Type (WT) Group and MTHFR677-Hetero Group

Change in serum folate levels between MTHFR677-Wild Type (WT) group and MTHFR677-Hetero group (NCT04177693)
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)

Interventionng/mL (Mean)
MTHFR677-Wild Type (WT) Group-3.2
MTHFR677-Hetero Group-2.0

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Change in Serum Folate Level Between MTHFR1298-Wild Type (WT) Group and MTHFR1298-Hetero Group

Change in serum folate levels between MTHFR1298-Wild Type (WT) group and MTHFR1298-Hetero group (NCT04177693)
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)

Interventionng/mL (Mean)
MTHFR1298-Wild Type (WT) Group-1.5
MTHFR1298-Hetero Group-3.8

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Change in Serum Folate Level Between DHFR-Wild Type (WT) Group and DHFR-Hetero or Homo Group.

Change in serum folate levels between DHFR-Wild Type (WT) group and DHFR-Hetero or homo group. (NCT04177693)
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)

Interventionng/mL (Mean)
DHFR-Wild Type (WT) Group-3.9
DHFR-Hetero or Homo Group.-2.1

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Changes in Total Bilirubin

Changes in total bilirubin between the 3 groups. (NCT04177693)
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)

Interventionmg/dL (Mean)
EGCG Daily Alone.0.1
EGCG With Clomiphene Citrate0
EGCG With Letrozole0

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Changes in Estrogen (E2)

Changes in Estrogen (E2) between the 3 groups. (NCT04177693)
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)

Interventionpg/mL (Mean)
EGCG Daily Alone.-50.9
EGCG With Clomiphene Citrate-49.4
EGCG With Letrozole-50.2

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Changes in Epigallocatechin Gallate (EGCG)

Changes in epigallocatechin gallate (EGCG) from Visit 1 to Visit 4 (end of study). EGCG levels measured at 1 hour after taking study medication were used for both visits. (NCT04177693)
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)

InterventionnM (Median)
EGCG Daily Alone.5.8
EGCG With Clomiphene Citrate256.3
EGCG With Letrozole86.4

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Changes in Epigallocatechin (EGC)

Changes in epigallocatechin (EGC) from Visit 1 to Visit 4 (end of study). EGC levels measured at 1 hour after taking study medication were used for both visits. (NCT04177693)
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)

InterventionnM (Median)
EGCG Daily Alone.-58.9
EGCG With Clomiphene Citrate8.9
EGCG With Letrozole35.4

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Changes in Epicatechin Gallate(ECG)

Changes in epicatechin gallate(ECG) from Visit 1 to Visit 4 (end of study). ECG levels measured at 1 hour after taking study medication were used for both visits. (NCT04177693)
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)

InterventionnM (Median)
EGCG Daily Alone.7.6
EGCG With Clomiphene Citrate64.1
EGCG With Letrozole60.3

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