11-hydroxyprogesterone, also known as 11β-hydroxyprogesterone, is a naturally occurring steroid hormone produced in the adrenal glands and ovaries. It is a precursor to the potent steroid hormone cortisol. 11-hydroxyprogesterone is synthesized from progesterone through the action of the enzyme 11β-hydroxylase. It is important in the biosynthesis of cortisol and aldosterone and is studied to understand the regulation of steroid hormone production, its potential role in various diseases such as congenital adrenal hyperplasia, and its use in hormone therapy.'
11-hydroxyprogesterone: RN given refers to unspecified stereoisomer [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]
| ID Source | ID |
|---|---|
| PubMed CID | 92750 |
| SCHEMBL ID | 572275 |
| MeSH ID | M0095787 |
| Synonym |
|---|
| 11-hydroxyprogesterone |
| 312-90-3 |
| 11beta-hydroxy-4-pregnen-3,20-dione |
| pregn-4-ene-11beta-ol-3,20-dione |
| pregn-4-ene-3,20-dione, 11-hydroxy- |
| SCHEMBL572275 |
| DTXSID801036226 |
| Timeframe | Studies, This Drug (%) | All Drugs % |
|---|---|---|
| pre-1990 | 26 (47.27) | 18.7374 |
| 1990's | 15 (27.27) | 18.2507 |
| 2000's | 4 (7.27) | 29.6817 |
| 2010's | 8 (14.55) | 24.3611 |
| 2020's | 2 (3.64) | 2.80 |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
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 moderate demand-to-supply ratio for research on this compound.
| This Compound (21.11) All Compounds (24.57) |
| Publication Type | This drug (%) | All Drugs (%) |
|---|---|---|
| Trials | 1 (1.75%) | 5.53% |
| Reviews | 1 (1.75%) | 6.00% |
| Case Studies | 1 (1.75%) | 4.05% |
| Observational | 0 (0.00%) | 0.25% |
| Other | 54 (94.74%) | 84.16% |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Comparison of Intramuscular and Subcutaneous Administration of 17-hydroxyprogesterone Caproate (17-OHPC) in Pregnancy [NCT04183452] | 24 participants (Actual) | Observational | 2020-06-16 | Terminated(stopped due to Sponsor stopped study as the study drugs were withdrawn from the market) | |||
| Use of 17α Hydroxyprogesterone Caproate for the Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor During Current Pregnancy. Double Blind, Randomized, Controlled Trial. [NCT01317225] | Phase 3 | 80 participants (Anticipated) | Interventional | 2011-06-30 | Recruiting | ||
| 17-Alpha-Hydroxyprogesterone Caproate for Reduction of Neonatal Morbidity Due to Preterm Birth in Twin and Triplet Pregnancies - A Concurrent Randomized Double-blinded Clinical Trial [NCT00163020] | Phase 2/Phase 3 | 321 participants (Actual) | Interventional | 2004-11-30 | Completed | ||
| Progestagens for the Tertiary Prophylaxis of Preterm Delivery in Women With Short Cervix. A Randomized Multicentre Trial [NCT01178788] | Phase 3 | 254 participants (Actual) | Interventional | 2010-02-28 | Completed | ||
| Relationship Between Plasma Concentration of (Hydroxyprogesterone Caproate) 17-OHPC and Preterm Birth [NCT03292731] | Phase 1/Phase 2 | 159 participants (Actual) | Interventional | 2018-02-12 | Terminated(stopped due to grant funding cycle ended) | ||
| Impact of a Higher Dose on the Pharmacokinetics of 17-alpha Hydroxyprogesterone Caproate in Obese Women [NCT03433040] | Phase 3 | 44 participants (Actual) | Interventional | 2017-08-23 | Completed | ||
| The Use Of Intramuscular Hydroxyprogesterone Caproate For Management Of Placenta Previa Before 34 Weeks Of Gestation [NCT03130504] | Phase 2 | 130 participants (Actual) | Interventional | 2016-04-01 | Completed | ||
| A Multi-Center, Randomized, Open-Label Study Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-inj [NCT02940522] | Phase 1 | 122 participants (Actual) | Interventional | 2016-09-30 | Completed | ||
| Z 31702 - Improving Pregnancy Outcomes With Progesterone (IPOP): a Trial of 17-Hydroxyprogesterone Caproate to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy [NCT03297216] | Phase 3 | 800 participants (Actual) | Interventional | 2018-02-07 | Completed | ||
| Comparing Intramuscular Versus Vaginal Progesterone for Prevention of Preterm Birth. [NCT00579553] | 174 participants (Actual) | Interventional | 2006-10-31 | Completed | |||
| Luteal Phase Support Using Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone Supplementation in High Responders Following GnRHa Triggering - A Prospective Randomized Controlled Trial [NCT04797338] | Phase 4 | 100 participants (Anticipated) | Interventional | 2017-12-29 | Recruiting | ||
| [NCT00809939] | Phase 3 | 800 participants (Anticipated) | Interventional | 2010-12-31 | Active, not recruiting | ||
| Histologic Evaluation of the Cervix at Risk for Preterm Birth Trial:Medical Versus Surgical Therapy [NCT00694967] | 92 participants (Actual) | Interventional | 2003-11-30 | Terminated(stopped due to Interim analysis showed no difference in outcome between treatment groups.) | |||
| A Phase III, Single-Center, Open-labeled, Randomized Controlled Study Assessing Injection Pain of Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via [NCT02937766] | Phase 3 | 60 participants (Actual) | Interventional | 2016-10-07 | Terminated(stopped due to The Sponsor elected to discontinue the study prematurely due to business reasons) | ||
| The Impact of Progesterone Treatment on Obstetrical Outcome Among Women With First Trimester Vaginal Bleeding [NCT01501890] | 0 participants (Actual) | Interventional | 2012-01-31 | Withdrawn(stopped due to never started) | |||
| 17-alpha-Hydroxyprogesterone Caproate (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM), Double-blinded Randomized Clinical Trial [NCT01119963] | Phase 2/Phase 3 | 152 participants (Actual) | Interventional | 2011-10-31 | Completed | ||
| Efficacy of 17-Hydroxyprogesterone Caproate in Expectantly Managed Early-onset Preeclampsia: A Randomized Controlled Study [NCT04077853] | Phase 4 | 80 participants (Actual) | Interventional | 2019-12-15 | Completed | ||
| The Primary Progesterone Therapy for Operable Breast Cancer : A Randomized Controlled Trial [NCT00123669] | Phase 2/Phase 3 | 1,000 participants (Actual) | Interventional | 1997-10-31 | Completed | ||
| A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Multifetal Gestation (STTARS) [NCT00099164] | Phase 3 | 795 participants (Actual) | Interventional | 2004-04-30 | Completed | ||
| A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk [NCT00135902] | Phase 3 | 800 participants (Actual) | Interventional | 2005-02-28 | Completed | ||
| Prevention of Preterm Delivery in Twin Pregnancies by 17 Alpha-hydroxyprogesterone Caproate [NCT00141908] | Phase 2 | 290 participants (Anticipated) | Interventional | 2006-10-31 | Completed | ||
| A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Nulliparous Women With a Short Cervix [NCT00439374] | Phase 3 | 657 participants (Actual) | Interventional | 2007-04-30 | Terminated(stopped due to Halted by NICHD after recommendation by DSMC to stop for futility) | ||
| Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes [NCT04807543] | Phase 2 | 100 participants (Actual) | Interventional | 2018-01-10 | Completed | ||
| [NCT00120640] | 0 participants (Actual) | Interventional | 2005-07-31 | Withdrawn(stopped due to funding) | |||
| A Study of the Pharmacology of 17-Hydroxyprogesterone Caproate in Pregnancy [NCT00409825] | Phase 2 | 61 participants (Actual) | Interventional | 2006-03-31 | Completed | ||
| Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial. [NCT01050647] | Phase 1/Phase 2 | 21 participants (Actual) | Interventional | 2010-02-28 | Completed | ||
| A Multi-Center, Non-Randomized Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood of Women With a Singleton Pregnancy and a Previous Singleton Spontaneous Preterm Delivery [NCT01899846] | Phase 1 | 30 participants (Actual) | Interventional | 2013-07-31 | Completed | ||
| Evaluation of the Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery [NCT00331695] | Phase 4 | 560 participants (Actual) | Interventional | 2006-06-30 | Completed | ||
| A Phase 3B, Multi-Center, Randomized, Double-Blind Study of Hydroxyprogesterone Caproate (HPC) Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery [NCT01004029] | Phase 3 | 1,740 participants (Actual) | Interventional | 2009-10-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Composite Neonatal Morbidity within the twin group is described as the presence of any one or more of the following neonatal morbidities (RDS, IVH-III/IV, BPD, PVL, sepsis, NEC, ROP-Stage 3/4, Perinatal Death). (NCT00163020)
Timeframe: measured as any event noted in the first 28 day following birth.
| Intervention | Twins - Components of Neonatal Morbidity (Number) |
|---|---|
| Twins Group = Test Arm - 17OHP | 46 |
| Twins Group - Placebo Arm | 19 |
Newborn Asphyxia or Hypoxic-ischemic encephalopathy (HEI) within the twin group is characterized by clinical and laboratory evidence of acute or subacute brain injury due to asphyxia (ie, hypoxia, acidosis). (NCT00163020)
Timeframe: measured during the first 28 days after delivery
| Intervention | Twins (Number) |
|---|---|
| Twins Group = Test Arm - 17OHP | 0 |
| Twins Group - Placebo Arm | 0 |
Newborn Birthweight within the twins group was measure following delivery and noted in grams. (NCT00163020)
Timeframe: measure following delivery
| Intervention | grams (Mean) |
|---|---|
| Twins Group = Test Arm - 17OHP | 2321 |
| Twins Group - Placebo Arm | 2469 |
Newborn Gestational age at delivery within the twin group is described as the gestational age of the baby on the day of birth. (NCT00163020)
Timeframe: determined at the time of birth
| Intervention | weeks of age for twin pregnancy (Mean) |
|---|---|
| Twins Group = Test Arm - 17OHP | 35.3 |
| Twins Group - Placebo Arm | 35.9 |
"Newborn Intraventricular hemorrhage (IVH) Stage III in the twin group is described as - IVH with ventricular dilatation.~Neonatal Intraventricular hemorrhage (IVH)Stage IV in the twin group is described as - IVH with parenchymal extension." (NCT00163020)
Timeframe: measured during the first 28 days after birth
| Intervention | Twins (Number) |
|---|---|
| Twins Group = Test Arm - 17OHP | 3 |
| Twins Group - Placebo Arm | 0 |
Newborn NEC in the twin group is described as the presence of any of the following: (1)unequivocal intramural air in abdominal radiograph; (2) perforation abdominal radiograph; (3) clinical evidence of perforation (erythema and induration of the abdominal wall or intrabdominal abscess formation); (4) characteristic findings observed at surgery or autopsy; (5) Stricture formation after an episode of suspected necrotizing enterocolitis. (NCT00163020)
Timeframe: measured in the first 28 days after birth
| Intervention | Twins (Number) |
|---|---|
| Twins Group = Test Arm - 17OHP | 0 |
| Twins Group - Placebo Arm | 0 |
Newborn Periventricular leukomalacia (PVL) in the twin group is described as the presence of more than 1 obvious hypo echoic cyst in the periventricular white matter. (NCT00163020)
Timeframe: measured in the first 28 days after birth.
| Intervention | participants (Number) |
|---|---|
| Twins Group = Test Arm - 17OHP | 1 |
| Twins Group - Placebo Arm | 1 |
Newborn Pneumonia in the twin group is described as compatible symptoms with diagnostic radiograph findings and positive results on blood cultures, persistent leukopenia (NCT00163020)
Timeframe: measure during the first 28 days after birth.
| Intervention | Twins (Number) |
|---|---|
| Twins Group = Test Arm - 17OHP | 1 |
| Twins Group - Placebo Arm | 0 |
"Newborn RDS in the twin arm is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or with respiratory insufficiency of prematurity requiring ventilator support.~Data expressed as mean n(%),Odds ratio, CI, and P-value were determined using repeated measures model wherein each twin/triplet within a given pregnancy is considered a repeated measure. Exceptions are comparison with 0 outcomes in one or both groups, so Fisher's Exact Test was used.~Morbidity measures were based on live births with data available for the outcomes." (NCT00163020)
Timeframe: Measured from delivery until 30 days after baby was discharged from the hospital
| Intervention | Twins (Number) |
|---|---|
| Twins Group = Test Arm - 17OHP | 44 |
| Twins Group - Placebo Arm | 18 |
Newborn ROP within the twin group is described as retinopathy confirmed on fundoscopic examination, felt to be due to prematurity and subsequent oxygen therapy. (NCT00163020)
Timeframe: measured during the first 28 day after birth
| Intervention | Twins (Number) |
|---|---|
| Twins Group = Test Arm - 17OHP | 2 |
| Twins Group - Placebo Arm | 0 |
Newborn Sepsis in the twin group was defined as the presence of positive blood culture obtained in the first week of life in association with clinical findings suggesting illness for which the neonate received antibiotics. (NCT00163020)
Timeframe: measured during the first week following birth
| Intervention | participants (Number) |
|---|---|
| Twins Group = Test Arm - 17OHP | 3 |
| Twins Group - Placebo Arm | 1 |
Drop-out rates in the twin group are described as any randomized participant who is withdrawn from the trial between randomization (as early at 16 weeks of pregnancy) and completion of the final dose of study medication (as late as 34 weeks of pregnancy). (NCT00163020)
Timeframe: any time from randomization to completion of final dose of study medication
| Intervention | participants (Number) |
|---|---|
| Twins Group = Test Arm - 17OHP | 8 |
| Twins Group - Placebo Arm | 5 |
Describe as the cessation of study related therapy for the participant within the twin group at anytime from initial study related injection until the final injection at 34 weeks of pregnancy. (NCT00163020)
Timeframe: anytime from initial injection to final injection at 34 weeks.
| Intervention | participants (Number) |
|---|---|
| Twins Group = Test Arm - 17OHP | 6 |
| Twins Group - Placebo Arm | 0 |
Perinatal death within the twin group is described as a stillbirth, neonatal death, or miscarriage after randomization. (NCT00163020)
Timeframe: measured from randomization to 28 days after birth.
| Intervention | Twins (Number) |
|---|---|
| Twins Group = Test Arm - 17OHP | 0 |
| Twins Group - Placebo Arm | 3 |
Supplemental oxygen use by the baby measured at the point that the baby reaches 28 days old (after birth)within the twin group. (NCT00163020)
Timeframe: Measured at 28 days after birth.
| Intervention | Twins (Number) |
|---|---|
| Twins Group = Test Arm - 17OHP | 9 |
| Twins Group - Placebo Arm | 0 |
Gestational age was noted at time of delivery and stratified into three categories (Triplets: Delivery prior to 28 wks, 32 wks, 35 wks) (NCT00163020)
Timeframe: noted at delivery
| Intervention | Triplet Pregnancies (Number) | ||
|---|---|---|---|
| Delivery before 28 weeks of gestation | Delivery before 32 weeks of gestation | Delivery before 35 weeks of gestation | |
| Triplet Group - Placebo Arm | 2 | 13 | 13 |
| Triplet Group = Test Arm - 17OHP | 9 | 19 | 43 |
Gestational age was noted at time of delivery and stratified into three categories (Twins: Delivery prior to 28 weeks (wks), 32 wks, 34 wks, and 37 wks) (NCT00163020)
Timeframe: Gestational age noted at time of birth
| Intervention | Twin Pregnancies (Number) | |||
|---|---|---|---|---|
| Delivery before 28 weeks of gestation | Delivery before 32 weeks of gestation | Delivery before 34 weeks of gestation | Delivery before 37 weeks of gestation | |
| Twins Group - Placebo Arm | 1 | 4 | 11 | 46 |
| Twins Group = Test Arm - 17OHP | 3 | 15 | 31 | 113 |
"Change in the area under the concentration vs. time curve in the second and third trimesters of pregnancy.~We compared AUC at each PK study visit. Measurements were obtained at 0, 1, 2, 3, 4, 5, 6, 7 days." (NCT00409825)
Timeframe: Second and third trimesters of pregnancy
| Intervention | ng/ML/day (Mean) | |
|---|---|---|
| AUC -1 | AUC - 2 | |
| Part 1 | 115 | 136 |
Birth weight as measured in grams (NCT00439374)
Timeframe: Delivery
| Intervention | Grams (Mean) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 2855 |
| Placebo | 2824 |
Number of participants who reported any side effect, nausea, urticaria, and/or an issue at the injection site (NCT00439374)
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Any | Injection site | Urticaria | Nausea | |
| 17 Alpha-hydroxyprogesterone Caproate | 223 | 217 | 10 | 7 |
| Placebo | 220 | 209 | 2 | 10 |
comprised of fetal or infant death, respiratory distress syndrome, intraventricular hemorrhage (grades 3 and 4), periventricular leukomalacia, necrotizing enterocolitis (stage II and III), Bronchopulmonary dysplasia /chronic lung disease, retinopathy of prematurity (stage III or higher), early onset sepsis (NCT00439374)
Timeframe: within 72 hours of delivery
| Intervention | Participants (Count of Participants) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Composite Outcome Total | Fetal Death | Neonatal Death | Respiratory Distress Syndrome | Bronchopulmonary dysplasia | Necrotizing enterocolitis, grade II or III | Intraventricular Hemorrhage, Grade III or IV | Periventricular Leukomalacia | Early-onset Sepsis | Retinopathy of prematurity, grade II or IV | |
| 17 Alpha-hydroxyprogesterone Caproate | 23 | 4 | 6 | 13 | 3 | 2 | 2 | 4 | 3 | 1 |
| Placebo | 30 | 1 | 8 | 16 | 5 | 5 | 1 | 1 | 11 | 3 |
Number of participants delivering before 37 weeks gestation by indication (NCT00439374)
Timeframe: Delivery before 37 weeks gestation
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Total Delivery <37 wk | Spontaneous | Medically indicated | Fetal loss/abortion <20 wk | |
| 17 Alpha-hydroxyprogesterone Caproate | 82 | 54 | 27 | 1 |
| Placebo | 80 | 55 | 25 | 0 |
Birth weight percentile and small for gestational age <10th percentile based on number of weeks and gender. (NCT00439374)
Timeframe: Delivery
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| < 10th percentile | < 3rd percentile | |
| 17 Alpha-hydroxyprogesterone Caproate | 54 | 15 |
| Placebo | 47 | 14 |
Birth weight by count of participants < 2500 grams and < 1500 grams (NCT00439374)
Timeframe: Delivery
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Birth weight < 2500g | Birth weight < 1500g | |
| 17 Alpha-hydroxyprogesterone Caproate | 72 | 23 |
| Placebo | 75 | 29 |
(NCT00439374)
Timeframe: <37 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 25 |
| Placebo | 24 |
(NCT00439374)
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 15 |
| Placebo | 13 |
The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score. (NCT00439374)
Timeframe: 5 minutes post delivery
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 15 |
| Placebo | 19 |
Number of participants who visited the hospital due to preterm labor before 37 weeks gestation (NCT00439374)
Timeframe: Between randomization and 37 weeks gestation
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 145 |
| Placebo | 151 |
Number of participants who underwent tocolytic therapy during pregnancy (NCT00439374)
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 35 |
| Placebo | 42 |
Number of participants who underwent corticosteroid therapy in pregnancy (NCT00439374)
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 55 |
| Placebo | 51 |
(NCT00439374)
Timeframe: delivery
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 67 |
| Placebo | 63 |
Number of participants who had a cerclage placement (NCT00439374)
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 6 |
| Placebo | 4 |
(NCT00439374)
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 11 |
| Placebo | 15 |
(NCT00439374)
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 29 |
| Placebo | 20 |
Delivery before 35 weeks gestation (NCT00439374)
Timeframe: Delivery
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 44 |
| Placebo | 53 |
Delivery before 32 weeks gestation (NCT00439374)
Timeframe: Delivery
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 28 |
| Placebo | 32 |
Presence of a major congenital anomaly at birth (NCT00439374)
Timeframe: Delivery
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 6 |
| Placebo | 2 |
Delivery before 28 weeks gestation (NCT00439374)
Timeframe: Delivery
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 15 |
| Placebo | 22 |
(NCT00439374)
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 46 |
| Placebo | 40 |
(NCT00439374)
Timeframe: Any time during pregnancy from randomization to delivery, a timeframe up to 20 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 1 |
| Placebo | 0 |
Number of neonates diagnosed with the heart defect patent ductus arteriosus (NCT00439374)
Timeframe: Delivery through neonatal discharge
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 2 |
| Placebo | 8 |
Number of neonates experiencing seizures from delivery to hospital discharge (NCT00439374)
Timeframe: Delivery through neonatal discharge
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 1 |
| Placebo | 2 |
Admission to the neonatal intensive care unit (NCT00439374)
Timeframe: Delivery through hospital discharge
| Intervention | Participants (Count of Participants) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 63 |
| Placebo | 69 |
Median length of stay in the neonatal intensive care unit in days (NCT00439374)
Timeframe: NICU admission through NICU discharge
| Intervention | days (Median) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 17 |
| Placebo | 15.5 |
Mean gestational age at delivery (NCT00439374)
Timeframe: Delivery
| Intervention | weeks (Mean) |
|---|---|
| 17 Alpha-hydroxyprogesterone Caproate | 37.6 |
| Placebo | 37.4 |
Delivery below 34 weeks gestation (NCT00579553)
Timeframe: From 16-20 weeks gestation through preterm delivery
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Delivery less than 34 weeks | Delivery less than 28 weeks | |
| Intramuscular Progesterone | 13 | 7 |
| Vaginal Progesterone | 14 | 8 |
Mean gestational age at delivery (NCT00579553)
Timeframe: From 16-20 weeks gestation through preterm delivery
| Intervention | Weeks gestation (Mean) |
|---|---|
| Intramuscular Progesterone | 35.8 |
| Vaginal Progesterone | 36.3 |
(NCT00579553)
Timeframe: At delivery
| Intervention | grams (Mean) |
|---|---|
| Intramuscular Progesterone | 2680.6 |
| Vaginal Progesterone | 2771.6 |
Delivery before 37 weeks gestation. (NCT00579553)
Timeframe: From 16-20 weeks gestation through preterm delivery
| Intervention | Participants (Count of Participants) |
|---|---|
| Intramuscular Progesterone | 29 |
| Vaginal Progesterone | 30 |
(NCT01004029)
Timeframe: Up to 37 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Vehicle | 125 |
| 17P (Hydroxyprogesterone Caproate Injection) | 257 |
(NCT01004029)
Timeframe: Up to 32 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Vehicle | 30 |
| 17P (Hydroxyprogesterone Caproate Injection) | 54 |
Determine if treatment with 17P reduces the rate of preterm birth < 35 weeks, 0 days of gestation in women with a previous singleton spontaneous preterm delivery. (NCT01004029)
Timeframe: Up to 35 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Vehicle | 66 |
| 17P (Hydroxyprogesterone Caproate Injection) | 122 |
Neonatal death (from minutes after birth until 28 days of life) occurring in liveborns born at 24 weeks gestation or greater (NCT01004029)
Timeframe: Until 28 days of life or discharge from the NICU whichever occurred later.
| Intervention | Participants (Count of Participants) |
|---|---|
| Vehicle | 2 |
| 17P (Hydroxyprogesterone Caproate Injection) | 3 |
Defined as spontaneous abortion/miscarriage (delivery from 16 weeks 0 days through 19 weeks 6 days of gestation) or neonatal death occurring in liveborns born at less than 24 weeks gestation or stillbirth (antepartum or intrapartum death from 20 weeks gestation through term), in the 17P group compared to the vehicle group (NCT01004029)
Timeframe: Delivery from 16 weeks 0 days through 19 weeks 6 days of gestation; or neonatal death occurring in liveborns born at less than 24 weeks gestation; or stillbirth (antepartum or intrapartum death) from 20 weeks gestation through term).
| Intervention | Participants (Count of Participants) |
|---|---|
| Vehicle | 11 |
| 17P (Hydroxyprogesterone Caproate Injection) | 19 |
The composite index is defined as a liveborn neonate with any of the following occurring at any time during the birth hospitalization up through discharge from the NICU: neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis or proven sepsis. (NCT01004029)
Timeframe: Until 28 days of life or discharge from the neonatal intensive care unit (NICU), whichever occurred later.
| Intervention | Participants (Count of Participants) |
|---|---|
| Vehicle | 28 |
| 17P (Hydroxyprogesterone Caproate Injection) | 61 |
Defined as all stillbirths/fetal deaths/in utero fetal losses occurring from 20 weeks gestation until term. (NCT01004029)
Timeframe: 20 weeks gestation until term
| Intervention | Participants (Count of Participants) |
|---|---|
| Vehicle | 3 |
| Hydroxyprogesterone Caproate Injection, 250 mg/mL | 12 |
Delayed delivery until 34 weeks gestation. (NCT01050647)
Timeframe: From enrollment until delivery, an average of 34 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| 17-hydroxyprogesterone Caproate | 0 |
| Castor Oil Injections | 0 |
(NCT01050647)
Timeframe: From delivery until neonatal hospital discharge, assessed up to 2 months
| Intervention | Participants (Count of Participants) |
|---|---|
| 17-hydroxyprogesterone Caproate | 7 |
| Castor Oil Injections | 10 |
(NCT01050647)
Timeframe: From delivery to neonatal discharge, assessed up to 2 months
| Intervention | Participants (Count of Participants) |
|---|---|
| 17-hydroxyprogesterone Caproate | 2 |
| Castor Oil Injections | 1 |
(NCT01050647)
Timeframe: From delivery until neonatal hospital discharge, assessed up to 2 months
| Intervention | Participants (Count of Participants) |
|---|---|
| 17-hydroxyprogesterone Caproate | 1 |
| Castor Oil Injections | 2 |
(NCT01050647)
Timeframe: From birth to discharge form delivery hospital, assessed up to 2 months
| Intervention | days (Mean) |
|---|---|
| 17-hydroxyprogesterone Caproate | 39 |
| Castor Oil Injections | 50 |
(NCT01050647)
Timeframe: From rupture of membranes until delivery, assessed up to 34 weeks of gestation
| Intervention | days (Median) |
|---|---|
| 17-hydroxyprogesterone Caproate | 14.5 |
| Castor Oil Injections | 8 |
Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the date the baby was born. (NCT01119963)
Timeframe: Measured from day of last menstrual cycle to day of birth and measured in weeks.
| Intervention | weeks. (Mean) |
|---|---|
| 17-alpha Hydroxyprogesterone Caproate, Makena® | 29.2 |
| Placebo | 29.5 |
"Secondary Outcomes:~- Duration of latency period (time from randomization to birth)" (NCT01119963)
Timeframe: average number of days measured from day of study entry until day of delivery
| Intervention | days (Mean) |
|---|---|
| 17-alpha Hydroxyprogesterone Caproate, Makena® | 17.1 |
| Placebo | 17.0 |
"Investigate the clinician's assessment of the ease of drug preparation associated with the administration of Makena® via subcutaneous auto-injector versus intramuscular injection as measured by a categorical scale.~Scores were as follows: completely dissatisfied = -3; mostly dissatisfied = -2, somewhat dissatisfied = -1, neither satisfied nor unsatisfied = 0, somewhat satisfied = 1, mostly satisfied = 2, completely satisfied = 3" (NCT02937766)
Timeframe: 4 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Treatment A | 2.8 |
| Treatment B | 2.5 |
"Investigate the clinician's assessment of the ease of injection technique associated with the administration of Makena® via subcutaneous auto-injector versus intramuscular injection as measured by a categorical scale.~Scores were as follows: completely dissatisfied = -3; mostly dissatisfied = -2, somewhat dissatisfied = -1, neither satisfied nor unsatisfied = 0, somewhat satisfied = 1, mostly satisfied = 2, completely satisfied = 3" (NCT02937766)
Timeframe: 4 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Treatment A | 2.8 |
| Treatment B | 2.3 |
"Comparison of average pain intensity associated with the administration of Makena® via subcutaneous autoinjector versus intramuscular injection (averaged over 4 visits).~Score on a scale: 0 (No Pain) up to 10 (Worst Pain Imaginable)" (NCT02937766)
Timeframe: 4 weeks
| Intervention | Participants with Injection Site Pain (Number) |
|---|---|
| Treatment A | 3 |
| Treatment B | 2 |
Comparison of PK Parameter AUC (0-168) for the Primary PK Population (NCT02940522)
Timeframe: 9 weeks
| Intervention | hr x ng/mL (Geometric Mean) |
|---|---|
| Treatment A | 813 |
| Treatment B | 790 |
Comparison of PK parameter t1/2 for the Primary PK Population (NCT02940522)
Timeframe: 9 weeks
| Intervention | hr (Geometric Mean) |
|---|---|
| Treatment A | 212 |
| Treatment B | 185 |
Comparison of the elimination rate constant for the Primary PK Population (NCT02940522)
Timeframe: 9 weeks
| Intervention | 1/hr (Geometric Mean) |
|---|---|
| Treatment A | 0.0033 |
| Treatment B | 0.0038 |
Comparison of areas under the curve (AUC) to the last time with a concentration ≥ LLOQ [AUC0-t] and to infinity [AUCinf] for the Primary PK Population (NCT02940522)
Timeframe: 9 weeks
| Intervention | hr x ng/mL (Geometric Mean) | |
|---|---|---|
| AUC(0-t) | AUC(inf) | |
| Treatment A | 2,313 | 2,469 |
| Treatment B | 2,098 | 2,175 |
Comparison of PK parameter Tmax for the Primary PK population (NCT02940522)
Timeframe: 9 weeks
| Intervention | hr (Geometric Mean) |
|---|---|
| Treatment A | 48.1 |
| Treatment B | 49.7 |
Comparison of the maximum plasma concentration (Cmax) for the Primary PK Population (NCT02940522)
Timeframe: 9 weeks
| Intervention | ng/mL (Geometric Mean) |
|---|---|
| Treatment A | 7.88 |
| Treatment B | 6.91 |
days from first injection to spontaneous preterm delivery (NCT03292731)
Timeframe: time in days from first injection to spontaneous preterm delivery
| Intervention | days (Mean) |
|---|---|
| Ancillary-250 mg | 150 |
| RCT Group 250 mg Dose | 144 |
| RCT Group -500 mg Dose | 145 |
| Summarized OHPC | 145 |
relationship between the rate of spontaneous preterm birth ( delivery < 37 weeks) and drug concentration obtained at 26-30 weeks among those with a blood sample and adherent to study protocol (n=116) (NCT03292731)
Timeframe: 26-30 week blood sample after a minimum of 7 injections among those with a blood sample and compliant with protocol(n=116)
| Intervention | Participants (Count of Participants) |
|---|---|
| Ancillary -250 mg | 1 |
| RCT Group 250 mg Dose | 9 |
| RCT Group -500 mg Dose | 12 |
| Summarized OHPC | 22 |
rate of preterm birth according to dosing group. Subjects were the same cohort in spec aims 1 and 2 . They were compliant with protocol, had a 26-30 week blood sample and did not miss more than 2 injections. (NCT03292731)
Timeframe: from enrollment till preterm delivery
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg Dose | 7 |
| 500 mg Dose | 9 |
Infants admitted to the NICU (NCT03292731)
Timeframe: any admission to the NICU from time of delivery to time of discharge from the hospital up to 30 days or transfer to another facility
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg Dose | 11 |
| 500 mg Dose | 16 |
| All RCT Groups | 27 |
Composite NN outcome (fetal death, neonatal death (NND), respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, intraventricular hemorrhage 3 or 4, retinopathy of prematurity, hypoxic-ischemic encephalopathy, seizures.) and NICU admission (NCT03292731)
Timeframe: till discharge from nicu up to 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Ancillary- 250 mg Dose | 3 |
| RCT - 250 mg Dose | 10 |
| RCT - 500 mg Dose | 12 |
| Summarized 17-OHPC | 25 |
days from when the 26-30 week blood sample was obtained to the gestation at spontaneous preterm birth. All blood samples were obtained after at least 7 injections were give by which time steady state would have been achieved. This analysis was limited to those with a 26-30 week blood sample who were compliant with the protocol (NCT03292731)
Timeframe: days from blood sample time to spontaneous preterm delivery
| Intervention | days (Mean) |
|---|---|
| Ancillary -250 mg | 74 |
| RCT Group 250 mg Dose | 73 |
| RCT Group -500mg Dose | 73 |
| Summarized OHPC | 73 |
"Plasma concentrations of 17-OHPC after 250 or 500 mg dose. Subjects were compliant with protocol up to the 26-30 week blood draw and had a blood sample available . This included subjects with indicated preterm birth and was not limited to those with spontaneous PTB. Plasma concentration among those receiving the 250 mg dose are compared to those receiving 500 mg dose.~Those receiving the 250 mg dose include both the RCT and ancillary groups." (NCT03292731)
Timeframe: Blood sample obtained at 26-30 weeks after a minimum of 7 injections and compliant with study protocol
| Intervention | ng/ml (Median) |
|---|---|
| 250 mg Dose | 8.6 |
| 500 mg Dose | 16.2 |
"Apgar score of less than 7 at 1 minute of life. Apgar stands for Appearance, Pulse, Grimace, Activity, and Respiration and is a quick test rated on a scale of 1-10 performed on a baby at one minute of life to determine how well the baby tolerated the birth process. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low." (NCT03297216)
Timeframe: 1 minute of life
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg 17P | 12 |
| Placebo | 9 |
Infant born with a weight below the 10th percentile for gestational age (NCT03297216)
Timeframe: Birth
| Intervention | Participants (Count of Participants) |
|---|---|
| 250mg 17P | 95 |
| Placebo | 93 |
Death of an infant following live birth (NCT03297216)
Timeframe: Birth through 28 days postpartum
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg 17P | 14 |
| Placebo | 7 |
Delivery prior to 28 gestational weeks (NCT03297216)
Timeframe: At delivery, up to 28 weeks of gestation
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg 17P | 3 |
| Placebo | 5 |
Delivery prior to 34 gestational weeks (NCT03297216)
Timeframe: At delivery, up to 34 weeks of gestation
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg 17P | 14 |
| Placebo | 16 |
Delivery prior to 37 gestational weeks (NCT03297216)
Timeframe: At delivery, up to 37 weeks of gestation
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg 17P | 31 |
| Placebo | 35 |
Infant born with a weight below the 3rd percentile for gestational age (NCT03297216)
Timeframe: Birth
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg 17P | 28 |
| Placebo | 47 |
A composite of live births prior to 37 weeks of gestation or stillbirth occurring at any gestational age (NCT03297216)
Timeframe: At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg 17P | 36 |
| Placebo | 36 |
Confirmed HIV infection in an infant (NCT03297216)
Timeframe: At 6 weeks of life
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg 17P | 1 |
| Placebo | 1 |
Delivery prior to 28 weeks of gestation that was initiated spontaneously, without provider intervention (NCT03297216)
Timeframe: At delivery, up to 28 weeks of gestation
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg 17P | 3 |
| Placebo | 4 |
Delivery prior to 34 weeks of gestation that was initiated spontaneously, without provider intervention (NCT03297216)
Timeframe: At delivery, up to 34 weeks of gestation
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg 17P | 10 |
| Placebo | 11 |
Delivery prior to 37 weeks of gestation that was initiated spontaneously, without provider intervention (NCT03297216)
Timeframe: At delivery, up to 37 weeks of gestation
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg 17P | 25 |
| Placebo | 26 |
Participants who had a fetus born without signs of life at any gestational age (NCT03297216)
Timeframe: At delivery, up to approximately 40 weeks of gestation
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg 17P | 10 |
| Placebo | 11 |
"Apgar score of less than 7 at 5 minutes of life. Apgar stands for Appearance, Pulse, Grimace, Activity, and Respiration and is a quick test rated on a scale of 1-10 performed on a baby at five minutes of life to assess how well the baby is doing following delivery. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low." (NCT03297216)
Timeframe: 5 minutes of life
| Intervention | Participants (Count of Participants) |
|---|---|
| 250 mg 17P | 7 |
| Placebo | 2 |
Blood levels (NCT03433040)
Timeframe: From enrollment to 36 weeks of pregnancy
| Intervention | ng/ml (Mean) | ||
|---|---|---|---|
| 20-22 weeks | 27-29 weeks | 34-36 weeks | |
| Non Obese | 10.1 | 11.5 | 15.2 |
| Obese | 18.0 | 17.9 | 24.6 |
| Obese - Control | 13.0 | 8.1 | 11.1 |
Gestational age at delivery in weeks . Too few to dichotomize to <37, 34 and 32 weeks as previously planned. (NCT03433040)
Timeframe: Up to 37 weeks
| Intervention | Weeks (Mean) |
|---|---|
| Non Obese | 36.7 |
| Obese - Control | 38.4 |
| Obese | 32.2 |
| Substance | Relationship Strength | Studies | Trials | Classes | Roles |
|---|---|---|---|---|---|
| coumarin 2H-chromen-2-one: coumarin derivative | 1.98 | 1 | 0 | coumarins | fluorescent dye; human metabolite; plant metabolite |
| glycine [no description available] | 2.05 | 1 | 0 | alpha-amino acid; amino acid zwitterion; proteinogenic amino acid; serine family amino acid | EC 2.1.2.1 (glycine hydroxymethyltransferase) inhibitor; fundamental metabolite; hepatoprotective agent; micronutrient; neurotransmitter; NMDA receptor agonist; nutraceutical |
| corticosterone [no description available] | 3.47 | 8 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; C21-steroid; glucocorticoid; primary alpha-hydroxy ketone | human metabolite; mouse metabolite |
| aldosterone [no description available] | 2.65 | 3 | 0 | 11beta-hydroxy steroid; 18-oxo steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; C21-steroid hormone; mineralocorticoid; primary alpha-hydroxy ketone; steroid aldehyde | human metabolite; mouse metabolite |
| estrone Hydroxyestrones: Estrone derivatives substituted with one or more hydroxyl groups in any position. They are important metabolites of estrone and other estrogens. | 1.96 | 1 | 0 | 17-oxo steroid; 3-hydroxy steroid; phenolic steroid; phenols | antineoplastic agent; bone density conservation agent; estrogen; human metabolite; mouse metabolite |
| uridine [no description available] | 2.37 | 2 | 0 | uridines | drug metabolite; fundamental metabolite; human metabolite |
| leucine Leucine: An essential branched-chain amino acid important for hemoglobin formation.. leucine : A branched-chain amino acid that consists of glycine in which one of the hydrogens attached to the alpha-carbon is substituted by an isobutyl group. | 1.98 | 1 | 0 | amino acid zwitterion; L-alpha-amino acid; leucine; proteinogenic amino acid; pyruvate family amino acid | algal metabolite; Escherichia coli metabolite; human metabolite; mouse metabolite; plant metabolite; Saccharomyces cerevisiae metabolite |
| androstenedione Androstenedione: A delta-4 C19 steroid that is produced not only in the TESTIS, but also in the OVARY and the ADRENAL CORTEX. Depending on the tissue type, androstenedione can serve as a precursor to TESTOSTERONE as well as ESTRONE and ESTRADIOL.. androst-4-ene-3,17-dione : A 3-oxo Delta(4)-steroid that is androst-4-ene substituted by oxo groups at positions 3 and 17. It is a steroid hormone synthesized in the adrenal glands and gonads. | 8.1 | 5 | 0 | 17-oxo steroid; 3-oxo-Delta(4) steroid; androstanoid | androgen; Daphnia magna metabolite; human metabolite; mouse metabolite |
| desoxycorticosterone Desoxycorticosterone: A steroid metabolite that is the 11-deoxy derivative of CORTICOSTERONE and the 21-hydroxy derivative of PROGESTERONE | 3.09 | 5 | 0 | 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; mineralocorticoid; primary alpha-hydroxy ketone | human metabolite; mouse metabolite |
| cycloheximide Cycloheximide: Antibiotic substance isolated from streptomycin-producing strains of Streptomyces griseus. It acts by inhibiting elongation during protein synthesis.. cycloheximide : A dicarboximide that is 4-(2-hydroxyethyl)piperidine-2,6-dione in which one of the hydrogens attached to the carbon bearing the hydroxy group is replaced by a 3,5-dimethyl-2-oxocyclohexyl group. It is an antibiotic produced by the bacterium Streptomyces griseus. | 1.96 | 1 | 0 | antibiotic fungicide; cyclic ketone; dicarboximide; piperidine antibiotic; piperidones; secondary alcohol | anticoronaviral agent; bacterial metabolite; ferroptosis inhibitor; neuroprotective agent; protein synthesis inhibitor |
| 17-alpha-hydroxyprogesterone 17alpha-hydroxyprogesterone : A 17alpha-hydroxy steroid that is the 17alpha-hydroxy derivative of progesterone. | 2.91 | 4 | 0 | 17alpha-hydroxy-C21-steroid; 17alpha-hydroxy steroid; tertiary alpha-hydroxy ketone | human metabolite; metabolite; mouse metabolite; progestin |
| dinitrofluorobenzene Dinitrofluorobenzene: Irritants and reagents for labeling terminal amino acid groups.. 1-fluoro-2,4-dinitrobenzene : The organofluorine compound that is benzene with a fluoro substituent at the 1-position and two nitro substituents in the 2- and 4-positions. | 1.99 | 1 | 0 | C-nitro compound; organofluorine compound | agrochemical; allergen; chromatographic reagent; EC 2.7.3.2 (creatine kinase) inhibitor; protein-sequencing agent; spectrophotometric reagent |
| asparagine Asparagine: A non-essential amino acid that is involved in the metabolic control of cell functions in nerve and brain tissue. It is biosynthesized from ASPARTIC ACID and AMMONIA by asparagine synthetase. (From Concise Encyclopedia Biochemistry and Molecular Biology, 3rd ed). asparagine : An alpha-amino acid in which one of the hydrogens attached to the alpha-carbon of glycine is substituted by a 2-amino-2-oxoethyl group. | 1.98 | 1 | 0 | amino acid zwitterion; asparagine; aspartate family amino acid; L-alpha-amino acid; proteinogenic amino acid | Escherichia coli metabolite; human metabolite; micronutrient; mouse metabolite; nutraceutical; plant metabolite; Saccharomyces cerevisiae metabolite |
| acetonitrile acetonitrile: RN given refers to unlabeled cpd. acetonitrile : A nitrile that is hydrogen cyanide in which the hydrogen has been replaced by a methyl group. | 2.13 | 1 | 0 | aliphatic nitrile; volatile organic compound | EC 3.5.1.4 (amidase) inhibitor; NMR chemical shift reference compound; polar aprotic solvent |
| 2-naphthylamine 2-Naphthylamine: A naphthalene derivative with carcinogenic action.. 2-naphthylamine : A naphthylamine carrying the amino group at position 2. | 2.03 | 1 | 0 | naphthylamine | carcinogenic agent |
| ethyl acetate ethyl acetate : The acetate ester formed between acetic acid and ethanol. | 2.03 | 1 | 0 | acetate ester; ethyl ester; volatile organic compound | EC 3.4.19.3 (pyroglutamyl-peptidase I) inhibitor; metabolite; polar aprotic solvent; Saccharomyces cerevisiae metabolite |
| pregnenolone [no description available] | 1.96 | 1 | 0 | 20-oxo steroid; 3beta-hydroxy-Delta(5)-steroid; C21-steroid | human metabolite; mouse metabolite |
| deuterium Deuterium: The stable isotope of hydrogen. It has one neutron and one proton in the nucleus. | 2.07 | 1 | 0 | dihydrogen | |
| phenyl acetate phenyl acetate: The ester formed between phenol and acetic acid. Don't confuse with phenylacetic acid derivatives listed under PHENYLACETATES.. phenyl acetate : An acetate ester obtained by the formal condensation of phenol with acetic acid. | 2.03 | 1 | 0 | benzenes; phenyl acetates | |
| pregnanolone Pregnanolone: A pregnane found in the urine of pregnant women and sows. It has anesthetic, hypnotic, and sedative properties.. 3alpha-hydroxy-5beta-pregnan-20-one : The 3alpha-stereoisomer of 3-hydroxy-5beta-pregnan-20-one. | 2.07 | 1 | 0 | 3-hydroxy-5beta-pregnan-20-one; 3alpha-hydroxy steroid | human metabolite; intravenous anaesthetic; sedative |
| promegestone Promegestone: A synthetic progestin which is useful for the study of progestin distribution and progestin tissue receptors, as it is not bound by transcortin and binds to progesterone receptors with a higher association constant than progesterone.. promegestone : A progestin consisting of 17beta-propionylestra-4,9-dien-3-one substituted at position 17 by a methyl group. | 1.97 | 1 | 0 | 20-oxo steroid; 3-oxo-Delta(4) steroid | antineoplastic agent; progesterone receptor agonist; progestin |
| indacrinone indacrinone: polyvalent saluretic; RN given refers to parent cpd without isomeric designation; structure | 1.96 | 1 | 0 | ||
| mifepristone Mifepristone: A progestational and glucocorticoid hormone antagonist. Its inhibition of progesterone induces bleeding during the luteal phase and in early pregnancy by releasing endogenous prostaglandins from the endometrium or decidua. As a glucocorticoid receptor antagonist, the drug has been used to treat hypercortisolism in patients with nonpituitary CUSHING SYNDROME. | 1.97 | 1 | 0 | 3-oxo-Delta(4) steroid; acetylenic compound; tertiary amino compound | abortifacient; contraceptive drug; hormone antagonist; synthetic oral contraceptive |
| triazoles Triazoles: Heterocyclic compounds containing a five-membered ring with two carbon atoms and three nitrogen atoms with the molecular formula C2H3N3.. triazoles : An azole in which the five-membered heterocyclic aromatic skeleton contains three N atoms and two C atoms. | 2.05 | 1 | 0 | 1,2,3-triazole | |
| 17-alpha-hydroxypregnenolone 17-alpha-Hydroxypregnenolone: A 21-carbon steroid that is converted from PREGNENOLONE by STEROID 17-ALPHA-HYDROXYLASE. It is an intermediate in the delta-5 pathway of biosynthesis of GONADAL STEROID HORMONES and the adrenal CORTICOSTEROIDS.. 17alpha-hydroxypregnenolone : A hydroxypregnenolone carrying an alpha-hydroxy group at position 17. | 1.96 | 1 | 0 | 17alpha-hydroxy-C21-steroid; 17alpha-hydroxy steroid; 3beta-hydroxy-Delta(5)-steroid; hydroxypregnenolone; tertiary alpha-hydroxy ketone | human metabolite; mouse metabolite |
| 21-deoxycortisol 21-deoxycortisol: RN given refers to (11beta)-isomer; structure. 21-deoxycortisol : A deoxycortisol that is 17xi-pregn-4-ene-3,20-dione substituted by a beta-hydroxy group at position 11 and an alpha-hydroxy group at position 17. It is a marker of virilizing adrenal hyperplasia caused by 21-hydroxylase deficiency. | 3.1 | 5 | 0 | 11beta-hydroxy steroid; 17alpha-hydroxy-C21-steroid; deoxycortisol; tertiary alpha-hydroxy ketone | human blood serum metabolite; mouse metabolite |
| 11-ketoprogesterone 11-ketoprogesterone: structure | 8.06 | 5 | 0 | corticosteroid hormone | |
| glucuronic acid Glucuronic Acid: A sugar acid formed by the oxidation of the C-6 carbon of GLUCOSE. In addition to being a key intermediate metabolite of the uronic acid pathway, glucuronic acid also plays a role in the detoxification of certain drugs and toxins by conjugating with them to form GLUCURONIDES.. D-glucuronic acid : The D-enantiomer of glucuronic acid.. D-glucopyranuronic acid : A D-glucuronic acid in cyclic pyranose form. | 2.39 | 2 | 0 | D-glucuronic acid | algal metabolite |
| laurdan laurdan: RN from CA Index Guide | 2.03 | 1 | 0 | ||
| 3-((3-cholamidopropyl)dimethylammonium)-1-propanesulfonate 3-((3-cholamidopropyl)dimethylammonium)-1-propanesulfonate: a surfactant; structure given in first source | 1.99 | 1 | 0 | 1,1-diunsubstituted alkanesulfonate | |
| 11-hydroxyandrostenedione 11-hydroxyandrostenedione: RN given refers to cpd without isomeric designation | 7.38 | 2 | 0 | 3-hydroxy steroid | androgen |
| 16-hydroxyprogesterone 16-hydroxyprogesterone: RN given refers to unlabeled cpd without isomeric designation | 2.11 | 1 | 0 | corticosteroid hormone | |
| propargylglycine propargylglycine: RN given refers to cpd without isomeric designation; structure | 2.05 | 1 | 0 | ||
| cortisone [no description available] | 2.47 | 2 | 0 | 11-oxo steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; C21-steroid; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | human metabolite; mouse metabolite |
| 1-dehydroprogesterone 1-dehydroprogesterone: RN given refers to cpd without isomeric designation. Delta(1)-progesterone : A 3-oxo Delta(4)-steroid that is progesterone which has been oxidised to introduce a double bond between positions 1 and 2. | 1.97 | 1 | 0 | 20-oxo steroid; 3-oxo-Delta(1),Delta(4)-steroid | |
| cortodoxone Cortodoxone: 17,21-Dihydroxypregn-4-ene-3,20-dione. A 17-hydroxycorticosteroid with glucocorticoid and anti-inflammatory activities.. 11-deoxycortisol : A deoxycortisol that is cortisol in which the hydroxy group at position 11 has been replaced by a hydrogen. | 3.39 | 7 | 0 | deoxycortisol; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | human metabolite; mouse metabolite |
| tretinoin Tretinoin: An important regulator of GENE EXPRESSION during growth and development, and in NEOPLASMS. Tretinoin, also known as retinoic acid and derived from maternal VITAMIN A, is essential for normal GROWTH; and EMBRYONIC DEVELOPMENT. An excess of tretinoin can be teratogenic. It is used in the treatment of PSORIASIS; ACNE VULGARIS; and several other SKIN DISEASES. It has also been approved for use in promyelocytic leukemia (LEUKEMIA, PROMYELOCYTIC, ACUTE).. retinoic acid : A retinoid consisting of 3,7-dimethylnona-2,4,6,8-tetraenoic acid substituted at position 9 by a 2,6,6-trimethylcyclohex-1-en-1-yl group (geometry of the four exocyclic double bonds is not specified).. all-trans-retinoic acid : A retinoic acid in which all four exocyclic double bonds have E- (trans-) geometry. | 1.96 | 1 | 0 | retinoic acid; vitamin A | anti-inflammatory agent; antineoplastic agent; antioxidant; AP-1 antagonist; human metabolite; keratolytic drug; retinoic acid receptor agonist; retinoid X receptor agonist; signalling molecule |
| arachidonic acid icosa-5,8,11,14-tetraenoic acid : Any icosatetraenoic acid with the double bonds at positions 5, 8, 11 and 14.. arachidonate : A long-chain fatty acid anion resulting from the removal of a proton from the carboxy group of arachidonic acid. | 2.03 | 1 | 0 | icosa-5,8,11,14-tetraenoic acid; long-chain fatty acid; omega-6 fatty acid | Daphnia galeata metabolite; EC 3.1.1.1 (carboxylesterase) inhibitor; human metabolite; mouse metabolite |
| dactinomycin Dactinomycin: A compound composed of a two CYCLIC PEPTIDES attached to a phenoxazine that is derived from STREPTOMYCES parvullus. It binds to DNA and inhibits RNA synthesis (transcription), with chain elongation more sensitive than initiation, termination, or release. As a result of impaired mRNA production, protein synthesis also declines after dactinomycin therapy. (From AMA Drug Evaluations Annual, 1993, p2015) | 1.96 | 1 | 0 | actinomycin | mutagen |
| deacylcortivazol deacylcortivazol: acts through glucocorticoid receptors; structure given in first source | 1.97 | 1 | 0 | ||
| pregna-1,4-diene-11-ol-3,20-dione pregna-1,4-diene-11-ol-3,20-dione: RN given refers to 11beta-isomer in Chemline; RN for unspecified isomer not in Chemline 7/11/83 | 1.96 | 1 | 0 | ||
| isotretinoin Isotretinoin: A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.. isotretinoin : A retinoic acid that is all-trans-retinoic acid in which the double bond which is alpha,beta- to the carboxy group is isomerised to Z configuration. A synthetic retinoid, it is used for the treatment of severe cases of acne and other skin diseases. | 1.96 | 1 | 0 | retinoic acid | antineoplastic agent; keratolytic drug; teratogenic agent |
| 11-dehydrocorticosterone 11-dehydrocorticosterone : An 11-oxo steroid that is corticosterone in which the hydroxy substituent at the 11beta position has been oxidised to give the corresponding ketone. | 1.99 | 1 | 0 | 11-oxo steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; corticosteroid; primary alpha-hydroxy ketone | human metabolite; mouse metabolite |
| phosphoramidite phosphoramidite: structure in first source. phosphoramidite : A compound with the general formula (RO)2PNR2. Phosphoramidites can be regarded as phosphites that have an NR2 instead of an OH group, or as amides of phosphorous acid. | 2.05 | 1 | 0 | ||
| nad NAD(1-) : An anionic form of nicotinamide adenine dinucleotide arising from deprotonation of the two OH groups of the diphosphate moiety. | 1.99 | 1 | 0 | organophosphate oxoanion | cofactor; human metabolite; hydrogen acceptor; Saccharomyces cerevisiae metabolite |
| bucladesine Bucladesine: A cyclic nucleotide derivative that mimics the action of endogenous CYCLIC AMP and is capable of permeating the cell membrane. It has vasodilator properties and is used as a cardiac stimulant. (From Merck Index, 11th ed). bucladesine : A 3',5'-cyclic purine nucleotide that is the 2'-butanoate ester and 6-N-butanoyl derivative of 3',5'-cyclic AMP. | 1.96 | 1 | 0 | 3',5'-cyclic purine nucleotide | |
| warfarin Warfarin: An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.. warfarin : A racemate comprising equal amounts of (R)- and (S)-warfarin. Extensively used as both an anticoagulant drug and as a pesticide against rats and mice.. 4-hydroxy-3-(3-oxo-1-phenylbutyl)-1-benzopyran-2-one : A member of the class of coumarins that is 4-hydroxycoumarin which is substituted at position 3 by a 1-phenyl-3-oxo-1-butyl group. | 1.98 | 1 | 0 | benzenes; hydroxycoumarin; methyl ketone |
| Condition | Indicated | Relationship Strength | Studies | Trials |
|---|---|---|---|---|
| Cancer of Prostate [description not available] | 0 | 2.63 | 2 | 0 |
| Prostatic Neoplasms Tumors or cancer of the PROSTATE. | 0 | 2.63 | 2 | 0 |
| Preterm Birth [description not available] | 0 | 3.01 | 1 | 0 |
| Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. | 0 | 4.14 | 6 | 0 |
| Premature Birth CHILDBIRTH before 37 weeks of PREGNANCY (259 days from the first day of the mother's last menstrual period, or 245 days after FERTILIZATION). | 0 | 3.01 | 1 | 0 |
| Congenital Adrenal Hyperplasia [description not available] | 0 | 3.08 | 5 | 0 |
| Cancer of Testis [description not available] | 0 | 2.11 | 1 | 0 |
| Adrenal Cortical Rest Tumor [description not available] | 0 | 2.11 | 1 | 0 |
| Adrenal Hyperplasia, Congenital A group of inherited disorders of the ADRENAL GLANDS, caused by enzyme defects in the synthesis of cortisol (HYDROCORTISONE) and/or ALDOSTERONE leading to accumulation of precursors for ANDROGENS. Depending on the hormone imbalance, congenital adrenal hyperplasia can be classified as salt-wasting, hypertensive, virilizing, or feminizing. Defects in STEROID 21-HYDROXYLASE; STEROID 11-BETA-HYDROXYLASE; STEROID 17-ALPHA-HYDROXYLASE; 3-beta-hydroxysteroid dehydrogenase (3-HYDROXYSTEROID DEHYDROGENASES); TESTOSTERONE 5-ALPHA-REDUCTASE; or steroidogenic acute regulatory protein; among others, underlie these disorders. | 0 | 3.08 | 5 | 0 |
| Testicular Neoplasms Tumors or cancer of the TESTIS. Germ cell tumors (GERMINOMA) of the testis constitute 95% of all testicular neoplasms. | 0 | 2.11 | 1 | 0 |
| Hyperplasia An increase in the number of cells in a tissue or organ without tumor formation. It differs from HYPERTROPHY, which is an increase in bulk without an increase in the number of cells. | 0 | 2.13 | 1 | 0 |
| Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed) | 0 | 2.13 | 1 | 0 |
| Alloxan Diabetes [description not available] | 0 | 1.93 | 1 | 0 |
| Glycosuria The appearance of an abnormally large amount of GLUCOSE in the urine, such as more than 500 mg/day in adults. It can be due to HYPERGLYCEMIA or genetic defects in renal reabsorption (RENAL GLYCOSURIA). | 0 | 1.93 | 1 | 0 |
| Infant, Newborn, Diseases Diseases of newborn infants present at birth (congenital) or developing within the first month of birth. It does not include hereditary diseases not manifesting at birth or within the first 30 days of life nor does it include inborn errors of metabolism. Both HEREDITARY DISEASES and METABOLISM, INBORN ERRORS are available as general concepts. | 0 | 1.96 | 1 | 0 |
| Alopecia Cicatrisata [description not available] | 0 | 4.04 | 3 | 1 |
| Dermatitis Seborrheica [description not available] | 0 | 1.96 | 1 | 0 |
| Alopecia Absence of hair from areas where it is normally present. | 0 | 4.04 | 3 | 1 |
| Dermatitis, Seborrheic A chronic inflammatory disease of the skin with unknown etiology. It is characterized by moderate ERYTHEMA, dry, moist, or greasy (SEBACEOUS GLAND) scaling and yellow crusted patches on various areas, especially the scalp, that exfoliate as dandruff. Seborrheic dermatitis is common in children and adolescents with HIV INFECTIONS. | 0 | 1.96 | 1 | 0 |
| Postpartum Amenorrhea [description not available] | 0 | 1.98 | 1 | 0 |
| Amenorrhea Absence of menstruation. | 0 | 1.98 | 1 | 0 |
| Choriocarcinoma A malignant metastatic form of trophoblastic tumors. Unlike the HYDATIDIFORM MOLE, choriocarcinoma contains no CHORIONIC VILLI but rather sheets of undifferentiated cytotrophoblasts and syncytiotrophoblasts (TROPHOBLASTS). It is characterized by the large amounts of CHORIONIC GONADOTROPIN produced. Tissue origins can be determined by DNA analyses: placental (fetal) origin or non-placental origin (CHORIOCARCINOMA, NON-GESTATIONAL). | 0 | 1.98 | 1 | 0 |
| Blood Pressure, High [description not available] | 0 | 2.4 | 2 | 0 |
| Hypertension Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more. | 0 | 2.4 | 2 | 0 |
| Contact Dermatitis [description not available] | 0 | 1.99 | 1 | 0 |
| Dermatitis, Contact A type of acute or chronic skin reaction in which sensitivity is manifested by reactivity to materials or substances coming in contact with the skin. It may involve allergic or non-allergic mechanisms. | 0 | 1.99 | 1 | 0 |
| Delayed Effects, Prenatal Exposure [description not available] | 0 | 2 | 1 | 0 |
| Experimental Hepatoma [description not available] | 0 | 1.97 | 1 | 0 |
| Acne [description not available] | 0 | 1.96 | 1 | 0 |
| Acne Vulgaris A chronic disorder of the pilosebaceous apparatus associated with an increase in sebum secretion. It is characterized by open comedones (blackheads), closed comedones (whiteheads), and pustular nodules. The cause is unknown, but heredity and age are predisposing factors. | 0 | 1.96 | 1 | 0 |
| Body Weight The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms. | 0 | 1.96 | 1 | 0 |