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norgestrel

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

Description

Norgestrel: A synthetic progestational agent with actions similar to those of PROGESTERONE. This racemic or (+-)-form has about half the potency of the levo form (LEVONORGESTREL). Norgestrel is used as a contraceptive, ovulation inhibitor, and for the control of menstrual disorders and endometriosis. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID121231040
MeSH IDM0014981

Synonyms (5)

Synonym
norgestrel
6533-00-2
ES-2467
levonorgestrel-d6 (major)
AKOS037652714

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Also examined was the probability that a side effect would occur in the 2nd or 3rd cycle if the user had not experienced such an effect in the 1st cycle."( The probability of side effects with ovral, norinyl 1/50 and norlestrin.
Berger, GS; Edelman, DA; Talwar, PP, 1979
)
0.26
" Climacteric symptoms, Kupperman index scores and potential adverse progestogen effects were recorded before treatment and three times per month during therapy."( Progestogens: therapeutic and adverse effects in early post-menopausal women.
Christiansen, C; Marslew, U; Riis, B, 1991
)
0.28
" Despite the overall high level of acceptability, some important variations were found with respect to the sociodemographic characteristics, effectiveness, satisafction, and adverse experiences between the 2 groups of acceptors in the study centers."( Evaluation of safety, efficacy, and acceptability of NORPLANT implants in Sri Lanka.
Balogh, SA; Basnayake, S; Thapa, S,
)
0.13
" Neither clinical, functional nor morphological investigations revealed toxic side effects of the drugs on the liver, the kidneys, the bone marrow, or on blood clotting function."( Toxicity of the progestagen STS 557 compared to levonorgestrel in beagles after oral administration for 6 months.
Güttner, J; Hillesheim, HG; Hoffmann, H; Oettel, M, 1982
)
0.26
" Although higher proportions of women in the vitamin B-6 group reported decreases in OC-related side effect severity between admission and the 30-day follow-up visit, these differences were appreciable only for headache and dizziness and none was statistically significant."( Effect of vitamin B6 on the side effects of a low-dose combined oral contraceptive.
Grubb, GS; Juárez-Perez, MA; Ponce de León, R; Villegas-Salas, E, 1997
)
0.3
" This analysis revealed that the OC exhibited a side effect profile that was similar, in many cases, to that of placebo."( Use of placebo controls in an oral contraceptive trial: methodological issues and adverse event incidence.
Godwin, AJ; Lippman, JS; Olson, W; Redmond, G, 1999
)
0.3
" Adverse events were typical of hormonal contraception, and most were mild-to-moderate in severity and not treatment limiting."( Efficacy and safety of a transdermal contraceptive system.
Creasy, GW; Fisher, AC; Lenihan, JP; Meador, ML; Shangold, GA; Smallwood, GH, 2001
)
0.31
"2%) participants experienced a serious adverse event classified as possibly, probably, or likely related to the patch."( A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho Evra/Evra).
Creasy, GW; Fisher, AC; Meador, ML; Odlind, V; Shangold, GA; Sibai, BM, 2002
)
0.31
"Overall, the contraceptive patch is well tolerated and has a side effect profile similar to an established oral contraceptive."( A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho Evra/Evra).
Creasy, GW; Fisher, AC; Meador, ML; Odlind, V; Shangold, GA; Sibai, BM, 2002
)
0.31
"evaluation of the frequency of adverse events during the therapy with a transdermal contraceptive system (TCS) in comparison to an oral contraceptive."( [Safety evaluation of a transdermal contraceptive system with an oral contraceptive].
Radowicki, S; Skórzewska, K; Szlendak, K, 2005
)
0.33
" Safety evaluation was based on the frequency of adverse effects, changes in physical and gynecological examinations."( [Safety evaluation of a transdermal contraceptive system with an oral contraceptive].
Radowicki, S; Skórzewska, K; Szlendak, K, 2005
)
0.33
"The incidence of most adverse effects was similar between the transdermal and oral contraceptive therapies, except of a higher incidence of breast pain, dysmenorrhoea and application site reactions in the patch group."( [Safety evaluation of a transdermal contraceptive system with an oral contraceptive].
Radowicki, S; Skórzewska, K; Szlendak, K, 2005
)
0.33
"The study suggests that a transdermal contraceptive system is a safe and well tolerated therapy."( [Safety evaluation of a transdermal contraceptive system with an oral contraceptive].
Radowicki, S; Skórzewska, K; Szlendak, K, 2005
)
0.33
"Treatment-emergent adverse events of 2% or greater in the LNG/EE contraceptive patch were nasopharyngitis (5."( Safety and tolerability of a new low-dose contraceptive patch in obese and nonobese women.
Archer, DF; Foegh, M; Kaunitz, AM; Mishell, DR, 2015
)
0.42
"The LNG/EE contraceptive patch and combination oral contraceptives were well tolerated and associated with similar treatment-emergent adverse event incidences in obese and nonobese women."( Safety and tolerability of a new low-dose contraceptive patch in obese and nonobese women.
Archer, DF; Foegh, M; Kaunitz, AM; Mishell, DR, 2015
)
0.42
" The aim of this study was to evaluate the incidence of TE using the Japanese Adverse Drug Event Report (JADER) database."( Thromboembolic adverse event study of combined estrogen-progestin preparations using Japanese Adverse Drug Event Report database.
Abe, J; Fukuda, A; Hane, Y; Hasegawa, S; Hatahira, H; Hirade, K; Kinosada, Y; Matsui, T; Motooka, Y; Naganuma, M; Nakamura, M; Sasaoka, S; Takahashi, Y, 2017
)
0.46

Pharmacokinetics

levonorgestrel was significantly lower in chronic OC users (mean elimination half-life of 30 hours) than in single-dose subjects. Measurement by radioimmunoassay of plasma levonorfestrel has been used to compare the pharmacokinetic parameters of the drug after oral and intravenous administration in control and liver-affected animals.

ExcerptReferenceRelevance
" Pharmacokinetic parameters calculated by graphical and regression analyses showed that the elimination half-life of the LN had a positive correlation and the peak plasma concentration a negative correlation with the 2 anthropometric indexes: weight/height sq."( Pharmacokinetics of levonorgestrel in Indian women belonging to low socio-economic group.
Nair, KM; Prema, K; Rao, BS; Sivakumar, B, 1979
)
0.26
"This investigation, using levonorgestrel, estimated the extent of a first-pass effect and established a pharmacokinetic model to describe drug concentrations after intravenous and oral administration."( Investigations of pharmacokinetics of levonorgestrel to specific consideration of a possible first-pass effect in women.
Hümpel, M; Pommerenke, G; Speck, U; Weiss, C; Wendt, H, 1978
)
0.26
"Serum concentration profiles and pharmacokinetic parameters (cmax, tmax, AUC24, AUC0-00, MRT) of ethinylestradiol (EE2) and levonorgestrel (LNG) were obtained following administration of two combined oral contraceptives."( Pharmacokinetics of ethinylestradiol and levonorgestrel after administration of two oral contraceptive preparations.
Brandstädt, A; Carol, W; Jäger, R; Kasch, R; Klinger, G, 1992
)
0.28
"Serum concentration profiles and pharmacokinetic parameters of ethinyl estradiol (EE2) and levonorgestrel (LNG) were obtained after administration of 2 combined oral contraceptives (OCs)."( Pharmacokinetics of ethinylestradiol and levonorgestrel after administration of two oral contraceptive preparations.
Brandstädt, A; Carol, W; Jäger, R; Kasch, R; Klinger, G, 1992
)
0.28
" Blood samples were collected at the end of each treatment month, assayed for EE and the half-life of elimination (Tel) and bioavailability (area under the serum concentration-time curve, AUC) calculated."( Intrasubject variability in the pharmacokinetics of ethynyloestradiol.
Fotherby, K, 1991
)
0.28
" Wide variations were observed between the women in the calculated pharmacokinetic parameters, while there was a relatively close correspondence between the intra-individually obtained values, except for one case."( [Inter- and intra-individual variability of pharmacokinetic parameters for contraceptive steroids].
Carol, W; Jäger, R; Kasch, R; Klinger, G; Michels, W, 1991
)
0.28
" The ranges of mean values calculated for other pharmacokinetic parameters were: volume of distribution: LNG--1."( Pharmacokinetic comparison of two triphasic oral contraceptive formulations containing levonorgestrel and ethinylestradiol.
Chiang, ST; Lobo, RA; Stanczyk, FZ; Woutersz, TB, 1990
)
0.28
"A pharmaceutical and pharmacokinetic study was carried out on levonorgestrel tablets from two different sources (Hungarian- and Chinese-made)."( Comparative cross-over pharmacokinetic study on two types of postcoital contraceptive tablets containing levonorgestrel.
Fotherby, K; He, CH; Liao, DL; Matlin, SA; Shi, YE; Van Look, PF; Vince, PM; Xu, JQ; Zhu, YH, 1990
)
0.28
" This wide variability in the pharmacokinetic parameters, problems that arise in the derivation and interpretation of the parameters, the biologic significance of most of these parameters, and their lack of correlation with pharmacodynamic responses severely limit the usefulness of pharmacokinetic studies of the gestagens."( Pharmacokinetics of gestagens: some problems.
Fotherby, K, 1990
)
0.28
" The mean half-life of elimination, usually calculated using two-compartment open modeling, ranged from 8 to 18 hours."( Pharmacokinetics of gestagens: some problems.
Fotherby, K, 1990
)
0.28
" The predictive value of single-dose administration for the pharmacokinetic behavior of a progestin during long-term treatment was investigated for two triphasic oral contraceptives."( Pharmacokinetics of the contraceptive steroids levonorgestrel and gestodene after single and multiple oral administration to women.
Kuhnz, W, 1990
)
0.28
"Biotransformation, pharmacologic, and pharmacokinetic studies of norgestimate and its metabolites indicate that 17-deacetyl norgestimate, along with the parent drug, contributes to the biologic response."( Pharmacologic and pharmacokinetic characteristics of norgestimate and its metabolites.
Flor, S; Hahn, DW; Kafrissen, ME; McGuire, JL; Phillips, A; Tolman, EL, 1990
)
0.28
" These differences in serum concentrations are determined by the different pharmacokinetic behaviour of the gestagens, which in turn is largely determined by their binding to serum proteins."( Potency and pharmacokinetics of gestagens.
Fotherby, K, 1990
)
0.28
" The pharmacokinetic properties of desogestrel were characterized by the following parameters: (1) maximum serum concentration, (2) time to maximum serum concentration, (3) total area under the serum concentration versus time curve, and (4) serum half-life of elimination."( Serum pharmacokinetics of orally administered desogestrel and binding of contraceptive progestogens to sex hormone-binding globulin.
Assendorp, R; Bergink, W; Kloosterboer, L; Qvist, I; van Lier, W; Voortman, G, 1990
)
0.28
" The pharmacokinetic properties of desogestrel were characterized by the following parameters: maximum serum concentration, time to maximum serum concentration, total area under the serum concentration vs time curve, and serum 1/2 life of elimination."( Serum pharmacokinetics of orally administered desogestrel and binding of contraceptive progestogens to sex hormone-binding globulin.
Assendorp, R; Bergink, W; Kloosterboer, L; Qvist, I; van Lier, W; Voortman, G, 1990
)
0.28
" Pharmacokinetic data showed pronounced interindividual variations."( [Pharmacokinetics of ethinyl estradiol following the administration of combination contraceptive preparations].
Carol, W; Jäger, R; Kasch, R; Klinger, G, 1990
)
0.28
"Plasma concentration profiles and pharmacokinetic parameters have been obtained following single dose administration of three commonly used oral contraceptive steroid preparations, Ovral, Nordette and Norminest to Egyptian women."( Pharmacokinetics of oral contraceptive steroids in Egyptian women: studies with Ovral, Nordette and Norminest.
Back, DJ; el-Raghy, I; Fathalla, M; Makeram, M; Orme, ML; Osman, F; Salem, H, 1986
)
0.27
" The volume of distribution was not significantly different in patients and controls; thus there was a tendency (nonsignificant) for the elimination half-life and area under curve after the intravenous dose to be less in the women with cystic fibrosis."( Pharmacokinetics of contraceptive steroids in patients with cystic fibrosis.
Back, DJ; Batten, JC; Grimmer, SF; Hodson, ME; Orme, ML; Rogers, SM; Stead, RJ, 1987
)
0.27
"6 ml/hr/kg and the half-life was 19."( Pharmacokinetics of single and multiple doses of ethinyl estradiol and levonorgestrel in relation to smoking.
D'Ambrosio, R; Gardner, MJ; Jusko, WJ; Kanarkowski, R; Tornatore, KM, 1988
)
0.27
" The clearance of levonorgestrel was significantly lower in chronic OC users (mean elimination half-life of 30 hours) than in single-dose subjects (mean elimination half-life of 23 hours)."( Pharmacokinetics of single and multiple doses of ethinyl estradiol and levonorgestrel in relation to smoking.
D'Ambrosio, R; Gardner, MJ; Jusko, WJ; Kanarkowski, R; Tornatore, KM, 1988
)
0.27
" The time to peak (tmax) was significantly longer and the peak concentration (Cmax) significantly reduced following vaginal administration."( Comparative pharmacokinetics of levonorgestrel and ethinyloestradiol following intravenous, oral and vaginal administration.
Back, DJ; Grimmer, SF; Orme, ML; Rogers, S; Stevenson, PJ, 1987
)
0.27
" It was found that the levonorgestrel decay rate after implant removal can be entirely accounted assuming one half-life of 42 +/- 16 h (mean +/- SD; range 13 to 62 h)."( Clearance of levonorgestrel from the circulation following removal of NORPLANT subdermal implants.
Cárdenas, H; Croxatto, HB; Díaz, S; Johansson, ED; Larsson, M; Pavez, M, 1988
)
0.27
"Pharmacokinetic and pharmacodynamic effects of a vaginal ring releasing 20 micrograms/day levonorgestrel (L-NOG) have been studied in 15 women."( Pharmacokinetic and pharmacodynamic studies of vaginal rings releasing low-dose levonorgestrel.
Feng, DD; Xiao, BL; Zhang, XL, 1985
)
0.27
" Plasma levels of levonorgestrel at various intervals after dosing were analysed by a specific radioimmunoassay and its pharmacokinetic parameters were computed."( Pharmacokinetics of levonorgestrel in Indian women.
Madhavan Nair, K; Narasinga Rao, BS; Prema, K; Sivakumar, B, 1983
)
0.27
" Measurement by radioimmunoassay of plasma levonorgestrel has been used to compare the pharmacokinetic parameters of the drug after oral and intravenous administration in both control and liver-affected animals."( Influence of acetaminophen-induced hepatic necrosis on the pharmacokinetics of levonorgestrel.
Gommaa, AA; Osman, FH, 1983
)
0.27
" had any significant effect on plasma concentrations of EE2 or levonorgestrel or on any pharmacokinetic parameter determined."( Pharmacokinetics of oral contraceptive steroids following the administration of the antimalarial drugs primaquine and chloroquine.
Back, DJ; Breckenridge, AM; Grimmer, SF; Orme, ML; Purba, HS, 1984
)
0.27
" Neither drug given 1 hour before the OC had any significant effect on pharmacokinetic concentrations of EE2 or levonorgestrel or on any pharmacokinetic parameter determined."( Pharmacokinetics of oral contraceptive steroids following the administration of the antimalarial drugs primaquine and chloroquine.
Back, DJ; Breckenridge, AM; Grimmer, SF; Orme, ML; Purba, HS, 1984
)
0.27
" Significance of dose-dependent pharmacokinetic studies is discussed."( Effect of dose on the pharmacokinetics of levonorgestrel in the rat during the rapid elimination phase following subcutaneous administration.
Lindberg, MC; Mitra, SB; Naqvi, RH, 1984
)
0.27
"The pharmacokinetic and pharmacodynamic effects of vaginal devices releasing levonorgestrel (L-NOG) at a constant rate (in vitro release: approximately 20 micrograms/day) were studied in a group of 20 normally menstruating women during a period of 90 days of continuous use."( Pharmacokinetic and pharmacodynamic investigations with vaginal devices releasing levonorgestrel at a constant, near zero order rate.
Diczfalusy, E; Johannisson, E; Landgren, BM; Masironi, B, 1982
)
0.26
"The purpose of the present report is to summarize the most important pharmacokinetic features of the new progestogens."( Pharmacokinetics of the new progestogens and influence of gestodene and desogestrel on ethinylestradiol metabolism.
Stanczyk, FZ, 1997
)
0.3
" This overview summarizes the relevant pharmacokinetic data for the contraceptive patch."( Pharmacokinetic overview of Ortho Evra/Evra.
Abrams, LS; Natarajan, J; Skee, D; Wong, FA, 2002
)
0.31
"The contraceptive patch exhibits an excellent pharmacokinetic profile, maintaining efficacious serum hormone concentrations under varying conditions."( Pharmacokinetic overview of Ortho Evra/Evra.
Abrams, LS; Natarajan, J; Skee, D; Wong, FA, 2002
)
0.31
"To determine the pharmacokinetic profile of norelgestromin (NGMN) and ethinyloestradiol (EE) following application of the contraceptive patch, Evra/Ortho Evra, at each of four anatomic sites (abdomen, buttock, arm, and torso)."( Pharmacokinetics of a contraceptive patch (Evra/Ortho Evra) containing norelgestromin and ethinyloestradiol at four application sites.
Abrams, LS; Anderson, GD; Natarajan, J; Skee, DM; Wong, FA, 2002
)
0.31
" Comparable systemic exposure of EE and 17-DNE in the presence and absence of dexloxiglumide suggests that dexloxiglumide treatment is unlikely to interfere with the safety and efficacy of oral contraceptives based on the analysis of the resulting pharmacokinetic profile."( Effect of multiple-dose dexloxiglumide on the pharmacokinetics of oral contraceptives in healthy women.
Abramowitz, W; Jakate, AS; Kapil, R; Patel, A; Persiani, S; Roy, P; Wangsa, J, 2005
)
0.33
" Plasma concentration-time profiles and pharmacokinetic parameters were characterized for EE and 2 major metabolites of norgestimate, norgestrel (NG) and 17-deacetyl norgestimate (17-DNGM)."( Absence of effect of oral rifaximin on the pharmacokinetics of ethinyl estradiol/norgestimate in healthy females.
Bettenhausen, DK; Connolly, M; Forbes, WP; Pentikis, H; Trapnell, CB, 2007
)
0.34
" No differences in pharmacokinetic parameters were observed for EE, NG, or 17-DNGM when a single dose of the OC was administered alone or with rifaximin."( Absence of effect of oral rifaximin on the pharmacokinetics of ethinyl estradiol/norgestimate in healthy females.
Bettenhausen, DK; Connolly, M; Forbes, WP; Pentikis, H; Trapnell, CB, 2007
)
0.34
" The clinical significance of the differences in pharmacokinetic and pharmacodynamic profiles between the patch and oral contraceptive is not fully known."( Pharmacokinetics and pharmacodynamics of a transdermal contraceptive patch and an oral contraceptive.
Devineni, D; Janssens, L; LaGuardia, KD; Leung, AT; Massarella, J; Skee, D; Vaccaro, N, 2007
)
0.34
"5, 2, 3, 4, 6, 8, 12, and 24 hours postdose on day 21 of each cycle for determination of AUC0-24 h and Cmax of ethinyl estradiol and norelgestromin."( Influence of taranabant, an orally active, highly selective, potent cannabinoid-1 receptor (CB1R) inverse agonist, on ethinyl estradiol and norelgestromin plasma pharmacokinetics.
Dunbar, S; Johnson-Levonas, AO; Lasseter, KC; Li, S; Miller, DL; Rosko, K; Schwartz, JI; Wagner, JA; Yuan, J, 2009
)
0.35
" The method has been successfully applied to a pharmacokinetic study of the ORTHO EVRA patch in rabbits."( Determination of norelgestromin in rabbit plasma by LC-MS/MS and its application to the pharmacokinetic study of ORTHO EVRA.
Ding, C; Ge, Q; Liu, X; Zhi, X; Zhou, Z, 2009
)
0.35
"Thirty-day, open-label, fixed-sequence, pharmacokinetic drug-drug interaction study."( Lack of effect of tenofovir disoproxil fumarate on pharmacokinetics of hormonal contraceptives.
Kearney, BP; Mathias, A, 2009
)
0.35
" Geometric mean ratios (90% confidence intervals) for the pharmacokinetic parameters for deacetyl norgestimate and ethinyl estradiol were estimated by using analysis of variance and compared with the no-effect criterion for bioequivalence."( Lack of effect of tenofovir disoproxil fumarate on pharmacokinetics of hormonal contraceptives.
Kearney, BP; Mathias, A, 2009
)
0.35
" Comparability would be declared if the 90% confidence intervals for the geometric mean ratio of AUC0-24hr and Cmax in the absence and presence of laropiprant were within predefined bounds (0."( Effect of laropiprant, a PGD2 receptor 1 antagonist, on estradiol and norgestimate pharmacokinetics after oral contraceptive administration in women.
Gutierrez, MJ; Johnson-Levonas, AO; Lai, E; Liu, F; Pramanik, B; Schwartz, JI; Wagner, JA; Wang, YH,
)
0.13
" This was a 112-day, open-label, fixed-sequence pharmacokinetic (PK) study in healthy female subjects that included a lead-in cycle (OC only; N = 21), cycle 1 (OC only; N = 15), cycle 2 (OC + sofosbuvir; N = 15), and cycle 3 (OC + ledipasvir; N = 15)."( Lack of a clinically important pharmacokinetic interaction between sofosbuvir or ledipasvir and hormonal oral contraceptives norgestimate/ethinyl estradiol in HCV-uninfected female subjects.
German, P; Mathias, A; Moorehead, L; Pang, P; Vimal, M, 2014
)
0.4
" Blood samples for pharmacokinetic analysis were taken until 168 hours postdose."( Evaluation of the effects of the weak CYP3A inhibitors atorvastatin and ethinyl estradiol/norgestimate on lomitapide pharmacokinetics in healthy subjects.
Dutta, S; Foulds, P; King, A; Korb, S; Patel, G; Sumeray, M; Wade, JR, 2016
)
0.43
"In study 1, pharmacokinetic exposures for EE in period 2 increased by 30% and the norgestimate metabolites decreased by approximately 15% when coadministered with elagolix."( Pharmacokinetic and Pharmacodynamic Profiles of Ethinylestradiol/Norgestimate Combination or Norethindrone upon Coadministration with Elagolix 150 mg Once Daily in Healthy Premenopausal Women.
Chiu, YL; Feldman, RA; Klein, CE; Ng, J, 2021
)
0.62
"Coadministration of elagolix 150 mg once daily with oral contraceptives containing EE and norgestimate, or norethindrone, resulted in small pharmacokinetic changes in the oral contraceptive components."( Pharmacokinetic and Pharmacodynamic Profiles of Ethinylestradiol/Norgestimate Combination or Norethindrone upon Coadministration with Elagolix 150 mg Once Daily in Healthy Premenopausal Women.
Chiu, YL; Feldman, RA; Klein, CE; Ng, J, 2021
)
0.62

Compound-Compound Interactions

The spermatogenic effects of levonorgestrel butanoate were studied in adult male bonnet monkeys when administered alone and in combination with testosterone buciclate. The results of the study suggest that the use of trimegestone in conjunction with E2 may be preferable to norgestrell because of the more favorable lipid profile.

ExcerptReferenceRelevance
" The four groups receiving hormone replacement therapy were given 2 mg estradiol valerate equivalents (E), either sequentially combined with 75 micrograms levonorgestrel (E/LNG), 10 mg medroxyprogesterone acetate (E/MPA), or 150 micrograms desogestrel (E/DG), or continuously combined with 1 mg cyproterone acetate (E/CPA)."( Serum lipids, lipoproteins, and apolipoproteins during postmenopausal estrogen replacement therapy combined with either 19-nortestosterone derivatives or 17-hydroxyprogesterone derivatives.
Christiansen, C; Haarbo, J; Hassager, C; Jensen, SB; Riis, BJ, 1991
)
0.28
" A multicenter study was therefore done, in which two preparations containing CA in combination with ethinylestradiol (EE) were compared with a marketed combined oral contraceptive pill."( Cyproterone acetate versus levonorgestrel combined with ethinyl estradiol in the treatment of acne. Results of a multicenter study.
Carlborg, L, 1986
)
0.27
" In combination with EE, however, DG seems to counteract the effects of EE to a lesser extent than NORG, as judged particularly from the effects on TG and PL in serum and VLDL."( The effects of two gonane progestins alone and in combination with ethinyl estradiol on serum lipoproteins.
Crona, N; Samsioe, G; Silfverstolpe, G, 1985
)
0.27
" In combination with EE, however, DG seems to be less "anti-oestrogenic" than NORG, as judged from the higher apo-AI and SHBG values after the combination DG + EE compared to those after NORG + EE."( Changes in serum apo-lipoprotein AI and sex-hormone-binding globulin levels after treatment with two different progestins administered alone and in combination with ethinyl estradiol.
Crona, N; Samsioe, G; Silfverstolpe, G, 1984
)
0.27
" In combination with EE, however, DG seems to be less antiestrogenic than NORG, as judged from the higher apo-AI and SHBG values after the combination of DG EE compared to those after NORG & EE."( Changes in serum apo-lipoprotein AI and sex-hormone-binding globulin levels after treatment with two different progestins administered alone and in combination with ethinyl estradiol.
Crona, N; Samsioe, G; Silfverstolpe, G, 1984
)
0.27
"The study purpose was to obtain additional clinical experience with 200 mcg of ethinyl estradiol combined with 2 mg dl-norgestrel as an emergency postcoital contraceptive."( A multicenter clinical investigation employing ethinyl estradiol combined with dl-norgestrel as postcoital contraceptive agent.
Rademaker, AW; Smith, RP; Yuzpe, AA, 1982
)
0.26
"125 mg Ng (norgestimate) combined with ."( Effects of norgestimate in combination with ethinyl estradiol on cervical mucus.
Borin, K; Moghissi, KS; Mohsenian, M, 1981
)
0.26
" It was concluded that 8 mg/kg testosterone buciclate would provide adequate androgen replacement when combined with 4 mg/kg levonorgestrel butanoate as a putative male contraceptive regimen."( A non-human primate study (baboon; Papio hamadryas) to determine if a long-acting progestogen, levonorgestrel butanoate, combined with a long-acting androgen, testosterone buciclate, can suppress spermatogenesis: I. Dose-finding study.
Butnev, VU; Goncharov, NP; Katzia, GV; Matikainen, T; Richkor, EG; Waites, GM, 1995
)
0.29
" This study was undertaken to compare safety and efficacy of a low dose of flutamide (125 mg twice daily) alone and in combination with a triphasic oral contraceptive (OC) in women with idiopathic hirsutism."( Clinical efficacy and safety of low-dose flutamide alone and combined with an oral contraceptive for the treatment of idiopathic hirsutism.
Cédrin, I; Dodin, S; Faure, N; Guy, J; Lemay, A; Méchain, C; Turcot-Lemay, L, 1995
)
0.29
" Nevertheless, at 6 months post-treatment this decrease was still significant only in the group who took flutamide in combination with an oral contraceptive."( Clinical efficacy and safety of low-dose flutamide alone and combined with an oral contraceptive for the treatment of idiopathic hirsutism.
Cédrin, I; Dodin, S; Faure, N; Guy, J; Lemay, A; Méchain, C; Turcot-Lemay, L, 1995
)
0.29
" Levonorgestrel butanoate at the same doses combined with two simultaneous injections of 40 mg testosterone buciclate (groups V, VI, VII), consistently suppressed spermatogenesis in the period 60-240 days and in most animals to azoospermia or severe oligozoospermia (<5 x 106/mL) during days 90-210."( Evaluation of the ability of levonorgestrel butanoate alone, or in combination with testosterone buciclate, to suppress spermatogenesis in the bonnet monkey (Macaca radiata).
Griffin, PD; Jeyaraj, DA; Pal, PC; Rajalakshmi, M; Sharma, RS; Waites, GM, 2000
)
0.31
" The results of the study suggest that the use of trimegestone in combination with E2 may be preferable to norgestrel because of the more favorable lipid profile."( Assessment of the metabolic tolerance in postmenopausal women over a 1-year period of two hormone replacement therapies containing estradiol in combination with either norgestrel or trimegestone.
Beijers-De Bie, L; De Villiers, TJ; Houben, PW; Magaril, C; Meuwissen, JH; Murga, M; Siseles, N; Spielmann, D; The, HS; Tuimala, R; Vihtamaki, T, 2002
)
0.31
"The spermatogenic effects of levonorgestrel butanoate were studied in adult male bonnet monkeys when administered alone and in combination with testosterone buciclate."( Effects of levonorgestrel butanoate alone and in combination with testosterone buciclate on spermatogenesis in the bonnet monkey.
Griffin, PD; Pal, PC; Rajalakshmi, M; Sharma, RS; Waites, GM, 2007
)
0.34
" This 2-period crossover study was conducted to evaluate the potential for drug-drug interaction between DMF (240 mg twice daily) and a combined oral contraceptive (OC; norgestimate 250 μg, ethinyl estradiol 35 μg)."( Evaluation of Potential Drug-Drug Interaction Between Delayed-Release Dimethyl Fumarate and a Commonly Used Oral Contraceptive (Norgestimate/Ethinyl Estradiol) in Healthy Women.
Kam, J; Leahy, M; Meka, V; Nestorov, I; Sheikh, SI; Zhao, G; Zhu, B, 2017
)
0.46
" Migraine predominately affects women of childbearing age; thus, it is important to determine potential drug-drug interactions between a common oral contraceptive and drugs used to treat migraine."( A Multi-Center, Open-Label, Pharmacokinetic Drug Interaction Study of Erenumab and a Combined Oral Contraceptive in Healthy Females.
Eisele, O; Gabriel, K; Lee, E; Mikol, DD; Vutikullird, A; Wang, Y; Xu, Y; Zhou, Y, 2019
)
0.51
"We sought to evaluate potential drug-drug interactions between erenumab and a common oral contraceptive."( A Multi-Center, Open-Label, Pharmacokinetic Drug Interaction Study of Erenumab and a Combined Oral Contraceptive in Healthy Females.
Eisele, O; Gabriel, K; Lee, E; Mikol, DD; Vutikullird, A; Wang, Y; Xu, Y; Zhou, Y, 2019
)
0.51

Bioavailability

The relative bioavailability of levonorgestrel (LNG) and ethinyl estradiol (EE) administered concomitantly both as an oral tablet and as a solution was assessed in a randomized two-period crossover study in 24 healthy women. In baboons, it was found that the bioavailability depended on the chain length of the esterified fatty acids, irrespective of the assay methods.

ExcerptReferenceRelevance
" Disappointing results with levonorgestrel nonanoate and levonorgestrel undecylate showed that elongation of the fatty acid, esterified with the steroid, decreased the bioavailability of the latter due to incomplete hydrolysis of the ester."( A new principle of injectable depot contraceptives. I Drug selection and studies in monkeys.
Hümpel, M; Schulze, PE; Speck, U, 1979
)
0.26
" Comparison of the results of the intravenous and oral administration of the steroid suggested that its oral bioavailability is 42%."( An investigation of the pharmacokinetics of ethynylestradiol in women using radioimmunoassay.
Back, DJ; Breckenridge, AM; Crawford, FE; MacIver, M; Orme, ML; Rowe, PH; Watts, MJ, 1979
)
0.26
" In addition, the bioavailability of EE, by comparison of its pharmacokinetics after intravenous and oral ingestion, was determined."( An investigation of the pharmacokinetics of ethynylestradiol in women using radioimmunoassay.
Back, DJ; Breckenridge, AM; Crawford, FE; MacIver, M; Orme, ML; Rowe, PH; Watts, MJ, 1979
)
0.26
" In baboons, it was found that the bioavailability of d-norgestrel depended on the chain length of the esterified fatty acids, irrespective of the assay methods."( Injectable depot contraceptives on d-norgestrel basis. I. Pharmacokinetic studies in dog and baboons.
Hümpel, M; Kühne, G; Schulze, PE; Speck, U, 1977
)
0.26
" Blood samples were collected at the end of each treatment month, assayed for EE and the half-life of elimination (Tel) and bioavailability (area under the serum concentration-time curve, AUC) calculated."( Intrasubject variability in the pharmacokinetics of ethynyloestradiol.
Fotherby, K, 1991
)
0.28
" Absorption and bioavailability of the Hungarian-made tablets were greater as evidenced by higher serum concentrations of levonorgestrel, a greater area under the concentration-time curve during the first 24 hours, and a more marked suppressive effect on SHBG levels."( Comparative cross-over pharmacokinetic study on two types of postcoital contraceptive tablets containing levonorgestrel.
Fotherby, K; He, CH; Liao, DL; Matlin, SA; Shi, YE; Van Look, PF; Vince, PM; Xu, JQ; Zhu, YH, 1990
)
0.28
" Another common parameter, mean pharmacokinetic bioavailability of LNG (as calculated by the area under the curve method), ranged from 20 to 35 ng/ml/hour in patients given 150 mcg of LNG with 30 mcg of ethinyl estradiol."( Pharmacokinetics of gestagens: some problems.
Fotherby, K, 1990
)
0.28
" Ethinyl estradiol (mean systemic bioavailability 40% to 50%) is extensively metabolized, principally to a sulfate conjugate."( Gastrointestinal metabolism of contraceptive steroids.
Back, DJ; Madden, S; Orme, ML, 1990
)
0.28
" Levonorgestrel was well absorbed and the serum levels remained almost constant throughout treatment."( Effects of treatment with oestradiol/levonorgestrel on bone, lipoproteins and hormone status in postmenopausal women.
Beastall, G; Farish, E; Fletcher, CD; Gray, CE; Hart, DM; Lindsay, R, 1989
)
0.28
"The bioavailability of ethinyloestradiol and levonorgestrel has been studied in 5 young women with an ileostomy following surgery for ulcerative colitis and compared to that in 5 control subjects."( The bioavailability of ethinyloestradiol and levonorgestrel in patients with an ileostomy.
Back, DJ; Cowie, A; Gilmore, I; Grimmer, SF; Orme, ML; Tjia, J, 1986
)
0.27
"The bioavailability of contraceptive steroids was studied in 12 women who were given an antacid and a contraceptive pill simultaneously."( Antacid does not reduce the bioavailability of oral contraceptive steroids in women.
Joshi, JV; Joshi, UM; Sankolli, GM; Shah, RS, 1986
)
0.27
" Apparently, self-dosing with this antacid will not affect bioavailability of oral contraceptive steroids."( Antacid does not reduce the bioavailability of oral contraceptive steroids in women.
Joshi, JV; Joshi, UM; Sankolli, GM; Shah, RS, 1986
)
0.27
" For bioavailability study, blood samples were collected twice weekly for a period of one month in the first cycle in 8 women."( Bioavailability of levonorgestrel from intravaginal rings in women of low income groups.
Madhavan Nair, K; Narasinga Rao, BS; Prema, K; Sivakumar, B, 1986
)
0.27
"The relative bioavailability of levonorgestrel (LNG) and ethinyl estradiol (EE) administered concomitantly both as an oral tablet and as a solution was assessed in a randomized two-period crossover study in 24 healthy women."( The relative bioavailability of levonorgestrel and ethinyl estradiol administered as a low-dose combination oral contraceptive.
Chiang, S; Goebelsmann, U; Hoffman, D; Woutersz, T, 1986
)
0.27
"The relative bioavailability of levonorgestrel (LNG) and ethinyl estradiol (EE) administered concomitantly both as an oral tablet and as a solution was assessed in a randomized 2-period crossover study in 24 healthy women."( The relative bioavailability of levonorgestrel and ethinyl estradiol administered as a low-dose combination oral contraceptive.
Chiang, S; Goebelsmann, U; Hoffman, D; Woutersz, T, 1986
)
0.27
" Phase II studies typically provide an opportunity to examine issues of efficacy and safety in a clinical target population and often permit a determination of the dose and dose intervals which will be most appropriate for that particular population and allow for a more definitive evaluation of the pharmacokinetics and, perhaps, bioavailability of a particular formulation."( Clinical evaluation of drugs used in fertility regulation.
Siemens, AJ, 1986
)
0.27
" In addition, the oral bioavailability of ethinyloestradiol was greater in women with cystic fibrosis than in controls (76."( Pharmacokinetics of contraceptive steroids in patients with cystic fibrosis.
Back, DJ; Batten, JC; Grimmer, SF; Hodson, ME; Orme, ML; Rogers, SM; Stead, RJ, 1987
)
0.27
" The bioavailability of ethinyl estradiol was significantly greater in women with cystic fibrosis (76."( Pharmacokinetics of contraceptive steroids in patients with cystic fibrosis.
Back, DJ; Batten, JC; Grimmer, SF; Hodson, ME; Orme, ML; Rogers, SM; Stead, RJ, 1987
)
0.27
"The relative bioavailability of levonorgestrel (LNG) and ethinylestradiol (EE2) administered as a conventional tablet (150/30) or capsule has been assessed in a randomized two-period crossover study in 9 healthy volunteer women."( The relative bioavailability of levonorgestrel and ethinylestradiol when administered in tablet and capsule form.
Back, DJ; Cohen, M; Elstein, M; Killick, SR; Shenoy, N; Stevenson, PJ, 1987
)
0.27
"9 female volunteers, aged 18-38 years participated in this study contrasting the bioavailability of levonorgestrel (LNG) and ethinylestradiol (EE2)."( The relative bioavailability of levonorgestrel and ethinylestradiol when administered in tablet and capsule form.
Back, DJ; Cohen, M; Elstein, M; Killick, SR; Shenoy, N; Stevenson, PJ, 1987
)
0.27
" Thus the distribution of synthetic steroids between various protein bound and nonprotein bound components in serum may influence their bioavailability at different target tissues."( Distribution and percentages of non-protein bound contraceptive steroids in human serum.
Hammond, GL; Lähteenmäki, P; Lähteenmäki, PL; Luukkainen, T, 1982
)
0.26
" The pharmacokinetic parameters of levonorgestrel in control mice showed some similarity to those observed in human subjects, save the systemic bioavailability which was about 67% in mice compared to 100% in humans."( Influence of acetaminophen-induced hepatic necrosis on the pharmacokinetics of levonorgestrel.
Gommaa, AA; Osman, FH, 1983
)
0.27
" However, very little is known concerning the bioavailability and plasma levels of unmetabolized gestagens in the animal species used for chronic toxicity testing and pharmacological investigation."( Terminal half-lives in plasma and bioavailability of norethisterone, levonorgestrel, cyproterone acetate and gestodene in rats, beagles and rhesus monkeys.
Düsterberg, B; Hümpel, M; Speck, U, 1981
)
0.26
" Comparison of the results of the intravenous and oral administration of the steroid show a mean systemic bioavailability of 89% after the 150 microgram dose and 99% after a 250 microgram dose."( The pharmacokinetics of levonorgestrel and ethynylestradiol in women - studies with Ovran and Ovranette.
Back, DJ; Bates, M; Breckenridge, AM; Hall, JM; MacIver, M; Orme, ML; Park, BK; Rowe, PH, 1981
)
0.26
" With reference to the present efforts to reduce the hormone content of the pill, 3 factors which influence the bioavailability of these substances are of great importance."( [Oral contraceptives. Clinical pharmacology, pharmacokinetics and drug interactions (author's transl)].
Staiger, C, 1982
)
0.26
" In addition, the initial absorption rate and removal half-life of L-NOG were assessed in 7 subjects using the devices for a period of 8 days only."( Pharmacokinetic and pharmacodynamic investigations with vaginal devices releasing levonorgestrel at a constant, near zero order rate.
Diczfalusy, E; Johannisson, E; Landgren, BM; Masironi, B, 1982
)
0.26
" Basic pharmacokinetic parameters of levonorgestrel were calculated and from the ratio of the AUC values obtained after both administrations, the bioavailability of norgestimate-derived levonorgestrel was calculated."( Systemic availability of levonorgestrel after single oral administration of a norgestimate-containing combination oral contraceptive to 12 young women.
Blode, H; Kuhnz, W; Mahler, M, 1994
)
0.29
" All of these agents are pharmacokinetically similar to older agents: they are highly bioavailable when administered orally, hepatically metabolized, and obtain steady-state concentrations after 8-10 days of continuous administration."( Desogestrel, norgestimate, and gestodene: the newer progestins.
Kaplan, B,
)
0.13
" All of these agents are highly bioavailable when administered orally, hepatically metabolized, and obtain steady-state concentrations after 8-10 days of continuous administration."( Desogestrel, norgestimate, and gestodene: the newer progestins.
Kaplan, B,
)
0.13
" This levels off until at the 10th day the absorption rate is 15 mcg/day."( Contraceptive pellet: small size but long life.
, 1977
)
0.26
" The comparative bioavailability was carried out on levonorgestrel tablets (0."( Bioequivalence study of postcoital emergency contraceptions containing levonorgestrel.
Chompootaweep, S; Leepipatpibul, S, 2004
)
0.32
" The comparative bioavailability of the two products was determined by the analysis of variance (ANOVA) for two way crossover design."( Bioequivalence study of postcoital emergency contraceptions containing levonorgestrel.
Chompootaweep, S; Leepipatpibul, S, 2004
)
0.32
" In addition, the 90% CI for the bioavailability contrasts (OC alone vs OC with rifaximin) for the maximum plasma concentration, area under the plasma concentration-time curve from zero to the last measurable plasma concentration or to infinity for EE, NG, and 17-DNGM all ranged from 86-118%."( Absence of effect of oral rifaximin on the pharmacokinetics of ethinyl estradiol/norgestimate in healthy females.
Bettenhausen, DK; Connolly, M; Forbes, WP; Pentikis, H; Trapnell, CB, 2007
)
0.34
" The very poor solubility and wettability of these drugs, along with their high potency (adsorption issues), give rise to difficulties in designing intravenous (IV) formulations to assess absolute bioavailability of products containing both drugs."( Norelgestromin/ethinyl estradiol intravenous infusion formulation optimization, stability and compatibility testing: A case study to overcome polysorbate 80 interference in chromatographic analysis.
Abdallah, IA; Hammell, DC; Hassan, HE; Stinchcomb, AL, 2016
)
0.43
" Doses were scaled from human doses to account for differences in bioavailability and body weight, and OCs were administered daily via oral gavage for 4 rat estrous cycles (20 days)."( The Effect of Oral Contraceptive Hormones on Anterior Cruciate Ligament Strength.
Chang, W; Dragoo, JL; Hsue, L; Konopka, JA; Thio, T, 2020
)
0.56

Dosage Studied

The currently recommended dosage of norethindrone and dl-norgestrel greatly exceed those necessary to suppress endometrial proliferation effectively. High norgest Rel dosages caused atrophies of the corpus endometrium significantly more often than low norgerrel dosages, desogestrel or lynestrenol.

ExcerptRelevanceReference
"The effects of two differing dosage schedules of ethinyloestradiol and levonorgestrel, taken cyclically as oral contraceptives, on blood pressure, body mass, blood glucose and serum triglycerides were measured."( The effect of cyclical administration of levonorgestrel and ethinyloestradiol on blood pressure, body mass, blood glucose and serum triglycerides.
Bloch, B, 1979
)
0.26
" Over the dosage range studied, the effects of the two kinds of estrogen were indistinguishable."( Comparative studies of the ethynyl estrogens used in oral contraceptives. VII. Effects with and without progestational agents on ultracentrifugally fractionated plasma lipoproteins in humans, baboons, and beagles.
Chenault, CB; de la Peña, A; Dozier, TS; Goldzieher, JW; Kraemer, DC, 1978
)
0.26
" Effects of the 2 kinds of estrogens were indistinguishable over the dosage range studied."( Comparative studies of the ethynyl estrogens used in oral contraceptives. VII. Effects with and without progestational agents on ultracentrifugally fractionated plasma lipoproteins in humans, baboons, and beagles.
Chenault, CB; de la Peña, A; Dozier, TS; Goldzieher, JW; Kraemer, DC, 1978
)
0.26
" The two oral contraceptive dosage forms studied produced qualitatively and quantitatively similar metabolic changes."( Metabolic effects of oral contraceptives containing 30 micrograms and 50 micrograms of oestrogen.
Cornish, EJ; Hain, R; Nash, AL, 1979
)
0.26
" In both studies, the 2 oral contraceptive dosage forms had similar metabolic quantitative and qualitative changes: both resulted in an increase in serum concentration of triglycerides (30 to 33%), B-lipoproteins (27 to 29%), and ceruloplasmin (75 to 90%), and a decrease in serum levels of antithrombin 3 (22 to 29%) and ascorbic acid (30 to 42%)."( Metabolic effects of oral contraceptives containing 30 micrograms and 50 micrograms of oestrogen.
Cornish, EJ; Hain, R; Nash, AL, 1979
)
0.26
" Each dosage increase improved cycle control and lessened bleeding irregularities."( Low-dose combination oral contraceptives: a controlled clinical study of three different norgestrel-ethinyl estradiol ratios.
Arnt, IC; Ferrari, A; Sartoretto, JN; Woutersz, TB, 1977
)
0.26
" A total of 1,991 patients were studied for more than two years while they were receiving various dosage combinations of these steroids."( Optimum dosage of an oral contraceptive. A report from the study of seven combinations of norgestimate and ethinyl estradiol.
Lawson, JS; Osterman, JJ; Pasquale, SA; Yuliano, SE, 1979
)
0.26
" Inhibition of the estrous cycle and vulvar enlargement were seen in all dosed dogs."( FDA studies of estrogen, progestogens, and estrogen/progestogen combinations in the dog and monkey.
Geil, RG; Lamar, JK, 1977
)
0.26
" The occurrence of a secondary peak in plasma at around 12 hours after dosing gave strong evidence that EE undergoes enterohepatic circulation in women; an event that may have considerable clinical significance."( An investigation of the pharmacokinetics of ethynylestradiol in women using radioimmunoassay.
Back, DJ; Breckenridge, AM; Crawford, FE; MacIver, M; Orme, ML; Rowe, PH; Watts, MJ, 1979
)
0.26
" This dosage schedule called for 4 tablets over 12 hours, and the clinician claims that this schedule avoids some of the semantic difficulties associated with the usual treatment of 50-60 tablets of estrogen over 5 days."( An alternative to the use of high-dose estrogens for postcoital contraception.
Schilling, LH, 1979
)
0.26
"This study determined whether a reduction in ethinyl estradiol (EE) dosage from 50-30 mcg was associated with any change in biological features of estrogenic effects in the genital tract (karyopyknotic index, ferning, spinnbarkeit, volume, and clarity of cervical mucus) or biochemical effects (ceruloplasmin and sex hormone binding globulin)."( Some estrogenic effects of two oral contraceptives consisting of norgestrel and two different doses of ethynylestradiol.
Bye, PG; Elstein, M; Fotherby, K; Miller, JF, 1979
)
0.26
" 189 campus women received the dosage of 2 tablets in 12 hours, given within 72 hours of unprotected intercourse."( Post-coital contraception using d1-norgestrel/ethinyl estradiol combination.
Ross, A; Smith, RP, 1978
)
0.26
" Malignant neoplasms were seen in dogs given 10 and 25 times the proposed human dosage of anagestone acetate plus mestranol and 25 times the proposed human dosage of WY-4355 plus mestranol and ethynerone plus mestranol."( Mammary nodules in beagle dogs administered investigational oral contraceptive steroids.
Casey, HW; Geil, RG; Giles, RC; Kwapien, RP, 1978
)
0.26
" The morphometric parameters as well as the histological pattern obtained of the anterior lobe of the pituitary gland appear to prove that in boar the antigonadotropic effect of norgestrel is lower than that of chloromadinone acetate, with dosage and duration of treatment identical."( [Quantifiable morphokinesis in members of the hypothalamo-adenohypophyseogonadal axis of hormonally castrated boars. 2. Studies on norgestrel treated boars].
Busch, W; Dorst, J; Hagelschuer, H; Sajonski, H, 1978
)
0.26
" The potency and dosage is correlated with the pathogenic effects observed."( Effects of contraceptive pills and intrauterine devices on urinary bladder.
Fayad, M; Kamel, M; Mooro, H; Osman, MI; Youssef, AF; Zahran, MM, 1976
)
0.26
" The serum levels of d-norgestrel were related to the dosage of dl-norgestrel ingested."( Serum levels of d-norgestrel, luteinizing hormone, follicle-stimulating hormone, estradiol, and progesterone in women during and following ingestion of combination oral contraceptives containing dl-norgestrel.
Brenner, PF; Goebelsmann, U; Mishell, DR; Stanczyk, FZ, 1977
)
0.26
"48 women, aged 17-41, were treated with weekly dosages of 1 mg ethinylestradiolsulfonate (EES) and a 10 mg dosage of norethisterone acetate (NEA) or a ."( [Changes of the endometrium during oral hormonal contraception with ethinyl estradiol sulfonate and norethisterone acetate or d-noregestrel].
Büttner, HH; Göretzlehner, G; Rudolf, K, 1976
)
0.26
" This decrease varied with the type of progestogen used in continuous low dosage therapy."( The effect of combination and low dose progestogen oral contraceptives on serum lipids.
Donde, UM; Virkar, K, 1975
)
0.25
"05 mg ethinyl estradiol per tablet), is given to young female rats at 50 x the human dosage for an extended period, plasma vitamin A levels are elevated about 50%."( Effect of Ovral, a combination type oral contraceptive agent, on vitamin A metabolism in rats.
Olson, JA; Supopark, W, 1975
)
0.25
" Research on combination norethynodrel-containing products revealed that the dosage was too high."( Oral contraception: a review.
Edgren, RA, 1991
)
0.28
"0 hours after dosing with their OCS on days 5, 6, 7 and 8 of their contraceptive cycle, for measurement of EE2, Ng, FSH and LH by radioimmunoassay."( The lack of interaction between temafloxacin and combined oral contraceptive steroids.
Back, DJ; Mant, T; Martin, C; Millar, E; Morrison, P; Orme, M; Tjia, J, 1991
)
0.28
"0 hours after dosing with OCs on days 5, 6, 7, and 8 of their contraceptive cycle, for measurement of EE2, Ng, FSH, and LH by radioimmunoassay."( The lack of interaction between temafloxacin and combined oral contraceptive steroids.
Back, DJ; Mant, T; Martin, C; Millar, E; Morrison, P; Orme, M; Tjia, J, 1991
)
0.28
" However, due to the low dosage of steroids, it is of utmost importance to avoid errors in its use."( Clinical experience with triphasic oral contraceptive (Triquilar) in 527 women in China.
Qian, LJ; Sang, GW; Weng, LJ; Xu, D; Zhang, JY; Zheng, HZ, 1991
)
0.28
" These results indicate that these changes are related to the dosage and estrogen-progestogen ratio of the preparation."( A comparative study of the effects of a monophasic and a triphasic oral contraceptive containing ethinyl estradiol and levonorgestrel on lipid and lipoprotein metabolism.
Holck, S; Loke, DF; Ng, CS; Ratnam, SS; Samsioe, G, 1990
)
0.28
" A further complication is the multiplicity of pharmacological effects elicited by the gestagens and each of these effects is likely to have its own dose-response relationship."( Potency and pharmacokinetics of gestagens.
Fotherby, K, 1990
)
0.28
" Contraceptive agents with reduced dosage of steroid components (rigevidon or triquilar) produced less pronounced increase in systolic or diastolic blood pressure (less than by 2-3 mm Hg)."( [Changes in arterial blood pressure of women using hormonal contraceptives in relation to their cardiovascular history].
Dubnitskaia, LV; Korsakov, SG; Manuilova, IA, 1989
)
0.28
" The recommended dosage is 2 tablets taken 12 hours apart, preferably within 12-24 hours, and no later that 72 hours, after intercourse."( Ovral as a "morning-after" contraceptive.
, 1989
)
0.28
" This even occurs with those methods which do not usually suppress ovulation, but the disturbance is generally less severe with lower dosage systems."( Menstrual changes associated with progestogen-only contraception.
Fraser, IS, 1986
)
0.27
" Studies of the oral contraceptives in current use show that the coagulation effects depend on the dosage of estrogen and the type of progestogen used in combination."( Coagulation effects of oral contraception.
Bonnar, J, 1987
)
0.27
" One of the main objects of the study was to determine whether the lower dosage would be sufficient to prevent the development of endometrial hyperplasia."( Clinical experience with a low-dose combination of estradiol valerate and levonorgestrel. Double-blind comparative study between SH D 386 F and Cyclabil. Effects on symptoms, lipids and endometrial condition.
Fredricsson, B; Hirt, M; Lagrelius, A; Weintraub, L, 1986
)
0.27
"Oral contraceptives were initially very high in estrogen and progestogen and had a uniform dosage schedule throughout the entire cycle."( Phasic approach to oral contraceptives.
Hale, RW, 1987
)
0.27
"Oral contraceptives were initially very high in estrogen and progestogen and had a uniform dosage schedule throughout the entire cycle."( Phasic approach to oral contraceptives.
Hale, RW, 1987
)
0.27
" This is the first dosing study of contraceptive steroids in a murine model of lupus."( Suppression of reproductive function in autoimmune NZB/W mice: effective doses of four contraceptive steroids.
Keisler, LW; Walker, SE, 1987
)
0.27
" High norgestrel dosages caused atrophies of the corpus endometrium significantly more often than low norgestrel dosages, desogestrel or lynestrenol at low dosage levels."( [Dependence of morphologic changes in portio, cervix and endometrium on dosage or potency of synthetic gestagens].
Dallenbach-Hellweg, G; Fenzel, J, 1985
)
0.27
"The effects of two cyclically administered, triphasic, combined low dosage oestrogen and progestogen oral contraceptives on haemostasis have been compared in a longitudinal study, over 6 months, in 26 healthy females aged 16-30 years."( A comparison of the effects of two triphasic oral contraceptives on haemostasis.
Cohen, H; Gillmer, MD; Machin, SJ; Mackie, IJ; Walshe, K, 1988
)
0.27
"Ethinylestradiol (EE), at a dosage of 5 mg/day for 5 consecutive days (5 mg EE), has generally been used for interception."( A comparison of high-dose estrogens versus low-dose ethinylestradiol and norgestrel combination in postcoital interception: a study in 493 women.
Haspels, AA; Van Santen, MR, 1985
)
0.27
"Ethinyl estradiol (EE), at a dosage of 5 mg/day for 5 consecutive days (5 mg EE) has generally been used for interception."( A comparison of high-dose estrogens versus low-dose ethinylestradiol and norgestrel combination in postcoital interception: a study in 493 women.
Haspels, AA; Van Santen, MR, 1985
)
0.27
"Eighty-six women of proved fertility used an incremental dosage regimen of a combined oral contraceptive for a total of 570 cycles over one year."( Assessment of incremental dosage regimen of combined oestrogen-progestogen oral contraceptive.
Brosens, IA; Robertson, WB; Van Assche, FA, 1974
)
0.25
" Serum percentage of iodine uptake, total thyroxine, free thoraxine, and weight changes in 38 women taking combination oral contraceptives and 27 taking low dosage progestagens were studied."( Thyroid functions of women taking oral contraceptives.
Barsivala, V; Virkar, K, 1974
)
0.25
" However, the currently recommended dosage of norethindrone and dl-norgestrel greatly exceed those necessary to suppress endometrial proliferation effectively."( Actions of progestins on the morphology and biochemistry of the endometrium of postmenopausal women receiving low-dose estrogen therapy.
King, RJ; Lane, G; Pryse-Davies, J; Ryder, T; Siddle, N; Townsend, PT; Whitehead, MI, 1982
)
0.26
" It is concluded that the dosages of progestins currently added in post-menopausal estrogen therapy are greatly in excess of those necessary to suppress endometrial proliferation effectively; lowering the daily progestin dosage is unlikely to result in any lessening of this protective effect and will probably reduce the incidence of side effects, as these appear to be dose-dependent."( Dose-dependent effects of synthetic progestins on the biochemistry of the estrogenized post-menopausal endometrium.
King, RJ; Minardi, J; Siddle, NC; Townsend, PT; Whitehead, MI; Young, O, 1981
)
0.26
" With the same contraceptive reliability its cycle stability is very much better than the monophase preparations, which are 40% high dosed in the progestin proportion (levonorgestrel and desogestrel)."( [Progress in oral contraception. Advantages of a levonorgestrel-containing 3-stage preparation over low-dose levonorgestrel and desogestrel containing monophasic combination preparations].
Lachnit-Fixson, U, 1984
)
0.27
" It is very difficult to show a correlation of ambiguous side effects such as depression and mood changes and the dosage level."( Advances in oral contraception. An international review of levonorgestrel and ethinyl estradiol.
Goldzieher, JW, 1983
)
0.27
" Plasma levels of levonorgestrel at various intervals after dosing were analysed by a specific radioimmunoassay and its pharmacokinetic parameters were computed."( Pharmacokinetics of levonorgestrel in Indian women.
Madhavan Nair, K; Narasinga Rao, BS; Prema, K; Sivakumar, B, 1983
)
0.27
" This finding demonstrates that postcoital STS 557 in the chosen dosage does not suppress ovulation."( STS 557 as an interceptive in baboons.
Goncharov, NP; Komor, A; Oettel, M; Schubert, K, 1983
)
0.27
"In the present study the Authors consider whether estroprogestins at low dosage may influence the basal levels of plasma Prolactin in a group of patients subdivided on the basis of their different ways of life."( Prolactin plasma levels and oral contraceptives at low dosage.
Dessole, S; Firinu, C; Milia, S; Piras, G, 1983
)
0.27
"In this study, the authors considered whether estroprogestins at low dosage may influence the basal levels of plasma prolactin (PRL) in a group of patients subdivided on the basis of different lifestyle."( Prolactin plasma levels and oral contraceptives at low dosage.
Dessole, S; Firinu, C; Milia, S; Piras, G, 1983
)
0.27
" Low dosage and strong affinity for target cell receptors are important in the selection of the appropriate agent."( Prescribing an oral contraceptive for the individual woman.
Chick, P, 1980
)
0.26
" The effectiveness of Stediril may be compromised by failure to follow the dosage schedule: 1 pill daily for 21 days followed by a pill-free interval of 7 days when withdrawal bleeding occurs."( [Stediril].
Csech, J; Gervais, C, 1984
)
0.27
" Due to the fact that menstrual cycles in a given woman may vary in length and that it takes patients several days on intermediate or long-acting insulin to achieve a steady state with regard to any dosage adjustment, it is difficult to design an insulin regimen that maintains euglycemia throughout the menstrual cycle in these labile patients."( Oral contraceptives abolish luteal phase exacerbation of hyperglycemia in type I diabetes.
Bleicher, SJ; Sacerdote, A,
)
0.13
" Analysis of the dose-response curves shows induction by Oe2 to be 10 times and 50 times greater than Oe3 and Oe4, respectively."( Different effects of oestradiol, oestriol, oestetrol and of oestrone on human breast cancer cells (MCF-7) in long term tissue culture.
Bayard, F; Jozan, S; Kreitmann, B, 1981
)
0.26
" The results indicate that hormonal contraception of the low dosage type may be administered to women with previously impaired glucose tolerance in pregnancy without any deterioration of the glucose metabolism post partum."( Low dosage oral contraception in women with previous gestational diabetes.
Kühl, C; Mølsted-Pedersen, L; Skouby, SO, 1982
)
0.26
"Scanning electron microscopy and a capillary tube sperm penetration test were used to study the cervical mucus of women using a triphasic oral contraceptive supplying a varying dosage of estrogen and gestagen during the cycle."( Ultrastructure of cervical mucus and sperm penetration during use of a triphasic oral contraceptive.
Myklebust, RU; Ulstein, M, 1982
)
0.26
" Half the dosage was administered immediately upon entry into the study and the remainder 12 hours later."( A multicenter clinical investigation employing ethinyl estradiol combined with dl-norgestrel as postcoital contraceptive agent.
Rademaker, AW; Smith, RP; Yuzpe, AA, 1982
)
0.26
"To study the effects of exogenous estrogens on the postmenopausal endometrium, and to determine the time course and minimum dosage of added progestins necessary to oppose estrogen stimulation, we obtained endometrial specimens from symptomatic postmenopausal women being treated with various preparations of estrogens and progestins."( Effects of estrogens and progestins on the biochemistry and morphology of the postmenopausal endometrium.
King, RJ; Pryse-Davies, J; Ryder, TA; Townsend, PT; Whitehead, MI, 1981
)
0.26
" Four women in each group were taking either a low dosage progestogen compound like norethisterone (NET) 350 micrograms or d-norgestrel (d-Ng) 50 micrograms alone or low dosage combination pills containing NET 1 mg or d-Ng 150 micrograms with 30 micrograms ethinyl estradiol (EE2) or a biodegradable implant containing 25 mg NET or d-Ng."( Release of 19-nor-testosterone type of contraceptive steroids through different drug delivery systems into serum and breast milk of lactating women.
Mehta, S; Saxena, BN; Toddywalla, VS; Virkar, KD, 1980
)
0.26
"01) suggest that a hypercoagulable state persists in low dosage OC users."( Large increase in plasmatic 11-dehydro-TxB2 levels due to oral contraceptives.
Donnez, J; Grandjean, P; Lavenne, E; Schlit, AF, 1995
)
0.29
" The use of the lowest efficacious dosage could reduce costs."( Clinical efficacy and safety of low-dose flutamide alone and combined with an oral contraceptive for the treatment of idiopathic hirsutism.
Cédrin, I; Dodin, S; Faure, N; Guy, J; Lemay, A; Méchain, C; Turcot-Lemay, L, 1995
)
0.29
" Up to date a drastic dosage reduction of both steroid hormones has been accomplished ameliorating the side effects on the one hand, and being active compounds as contraceptives, in the other."( [Endometrial interference of synthetic estrogens in fertility regulation.Is it necessary to interfere with the antiovulatory mechanism at the central nervous system level in order to obtain contraception?].
Cortés-Gallegos, V; Rojas, T; Sojo Aranda, QI, 1997
)
0.3
"Our purpose was to compare the effects on fasting plasma lipoprotein lipids of adding low dosage C-19 continuous progestin (dl-norgestrel) versus conventional low-dosage continuous C-21 progestin (medroxyprogesterone acetate) to cyclic conjugated estrogen therapy."( Effects of adding C-19 versus C-21 progestin to conjugated estrogen in moderately hypercholesterolemic postmenopausal women.
Koval, JJ; Nisker, JA; Wolfe, BM, 1998
)
0.3
"To compare the effects of (i) continuous low dosage C-19 progestin (dl-norgestrel, NG) plus cyclical conjugated estrogen (CEE) versus (ii) continuous low dosage C-21 progestin [medroxyprogesterone acetate (MPA)] plus CEE on postmenopausal vaginal bleeding, mood and somatic, psychosomatic and psychological symptoms."( Impact on postmenopausal symptoms of adding continuous C-21 versus C-19 progestin to estrogen.
Koval, JJ; Nisker, JA; Wolfe, BM, 1999
)
0.3
"Pulsed dosing of NGM 90 microg for 3 days off and 3 days on along with continuous administration of E2 is effective in treating vasomotor symptoms and vulvovaginal atrophy, provides endometrial protection (i."( Efficacy and safety of a constant-estrogen, pulsed-progestin regimen in hormone replacement therapy.
Caubel, P; Lane, R; Sulak, PJ,
)
0.13
"This study was undertaken to evaluate the effects of 3 dosage levels of intermittent norgestimate plus a constant dose of 17beta-estradiol on blood lipid and lipoprotein concentrations in 236 postmenopausal women."( A novel intermittent regimen of norgestimate to preserve the beneficial effects of 17beta-estradiol on lipid and lipoprotein profiles.
Caubel, P; Lane, R; Lobo, RA; Zacur, HZ, 2000
)
0.31
" Dose-response increases to peak levels of levonorgestrel were attained on day 7 in groups V, VI and VII, after the first injection."( Evaluation of the ability of levonorgestrel butanoate alone, or in combination with testosterone buciclate, to suppress spermatogenesis in the bonnet monkey (Macaca radiata).
Griffin, PD; Jeyaraj, DA; Pal, PC; Rajalakshmi, M; Sharma, RS; Waites, GM, 2000
)
0.31
" Dose-response experiments indicated that the lowest stimulatory concentration of 17 beta-estradiol, DHT, and norgestrel is 10(-11) M, 10(-10) M, and 10(-10) M, respectively."( The normal epithelial cell-specific 1 (NES1) gene is up-regulated by steroid hormones in the breast carcinoma cell line BT-474.
Diamandis, EP; Grass, L; Luo, LY,
)
0.13
" Serial blood samples were collected before and after dosing and assayed using validated methods."( Lack of effect of a high-fat meal on the bioavailability of 17 beta-estradiol/norgestimate in healthy postmenopausal women.
Bourg, D; Curtin, CR; Gisclon, LG; Larson, KL; Morrison, DN; Natarajan, J; Wong, FA, 2000
)
0.31
" In a new type of HRT three-day dosing with 17 beta-estradiol (E2) alone is followed by three-day dosing with E2 plus NGM."( Norgestimate. From the laboratory to three clinical indications.
Henzl, MR, 2001
)
0.31
" The contraceptive patch provided ovulation suppression and cycle control similar to that of oral norgestimate 250 microg/EE 35 microg, significantly decreased mean maximum follicular diameter following a 3-day intentional delayed dosing phase when compared with oral levonorgestrel (LNG) 50/75/125 microg/EE 30/40/30 micorg and oral LNG 100 microg/EE 20 microg, and was as effective as oral LNG 50/75/125 microg/EE 30/40/30 microg and oral desogestrel 150 microg/EE 20 microg in altering cervical mucus composition (i."( Transdermal contraception.
Abrams, LS; Creasy, GW; Fisher, AC, 2001
)
0.31
" Eighty-five women who met study criteria, made minimal dosing errors, and underwent at least three ultrasonographic examinations were analyzed."( Predicting risk of ovulation in new start oral contraceptive users.
Creinin, MD; Pymar, HC; Reid, L; Schwartz, JL, 2002
)
0.31
" A major advantage of this method compared to oral contraceptives is a nearly 90% perfect adherence to the dosing schedule across all age groups."( The transdermal contraceptive patch: a new approach to hormonal contraception.
Burkman, RT,
)
0.13
"The effect on liver functions of oral contraceptives (OCs) was studied by measuring the effect low dosage (Primovlar and Ovulen) OCs on serum pseudocholine esterase, a hepatic enzyme."( Effect of low dosage contraceptive pills on serum pseudocholine esterase level.
El Khodary, M; Mikaty, N; Nagui, AR; Shaarawy, M; Shalaby, M, 1976
)
0.26
" Lipid modifications provoked by combined OCs are a function of the nature and dosage of the components."( [Sex steroids and vascular risk].
Rozenbaum, H,
)
0.13
"To compare the effects of the contraceptive patch to oral contraceptives (OCs) on follicular size and incidence of ovulation in normal cycles and after dosing errors."( Ortho Evra/Evra versus oral contraceptives: follicular development and ovulation in normal cycles and after an intentional dosing error.
Archer, DF; Creasy, GW; Fisher, AC; Moreau, M; Pierson, RA; Shangold, GA, 2003
)
0.32
"Follicular size and incidence of ovulation were significantly reduced among contraceptive patch users compared with women using OCs in normal cycles and after planned dosing errors."( Ortho Evra/Evra versus oral contraceptives: follicular development and ovulation in normal cycles and after an intentional dosing error.
Archer, DF; Creasy, GW; Fisher, AC; Moreau, M; Pierson, RA; Shangold, GA, 2003
)
0.32
" Reduced frequency of dosing has the potential to improve patient compliance."( Transdermal delivery of sex steroids for hormone replacement therapy and contraception. A review of principles and practice.
Henzl, MR; Loomba, PK, 2003
)
0.32
"250 mg per 7-day phase, respectively) for 5 days (days 17-21) concurrently with either 200 mg dexloxiglumide (3 times a day on days 17-20, followed by a single dose on day 21) or matching placebo during 2 consecutive 28-day OC dosing cycles."( Effect of multiple-dose dexloxiglumide on the pharmacokinetics of oral contraceptives in healthy women.
Abramowitz, W; Jakate, AS; Kapil, R; Patel, A; Persiani, S; Roy, P; Wangsa, J, 2005
)
0.33
" continuous oral contraceptive (OC) dosing regimens, to explore follicular development during the hormone-free interval (HFI) and to examine follicular development following OC discontinuation."( Ovarian follicular dynamics during conventional vs. continuous oral contraceptive use.
Birtch, RL; Olatunbosun, OA; Pierson, RA, 2006
)
0.33
"Administration of a 3 day dosing regimen of oral rifaximin was well tolerated and did not alter the pharmacokinetics of a commonly used combination OC containing EE and norgestimate."( Absence of effect of oral rifaximin on the pharmacokinetics of ethinyl estradiol/norgestimate in healthy females.
Bettenhausen, DK; Connolly, M; Forbes, WP; Pentikis, H; Trapnell, CB, 2007
)
0.34
"Film forming polymeric solutions may present an alternative to the common transdermal dosage forms such as patches or gels."( Delivery of ethinylestradiol from film forming polymeric solutions across human epidermis in vitro and in vivo in pigs.
Franke, P; Lehr, CM; Schaefer, UF; Zurdo Schroeder, I, 2007
)
0.34
"Tenofovir DF and norgestimate-ethinyl estradiol are not involved in a clinically significant drug-drug interaction; tenofovir DF did not affect the steady-state pharmacokinetics of norgestimate or ethinyl estradiol, including the concentration at the end of the dosing interval."( Lack of effect of tenofovir disoproxil fumarate on pharmacokinetics of hormonal contraceptives.
Kearney, BP; Mathias, A, 2009
)
0.35
" This might be an effect of the convenience of the weekly dosing schedule."( Evaluation of the contraceptive efficacy, compliance, and satisfaction with the transdermal contraceptive patch system Evra: a comparison between adolescent and adult users.
Bodner, K; Bodner-Adler, B; Grünberger, W, 2011
)
0.37
" The peak plasma concentration (C(max)), area under the concentration-time curve for a dosing interval (AUC([τ])), and lowest plasma concentration (C(min)) for EE and NGMN during cycles of treatment with Ortho Cyclen with and without coadministration of efavirenz were compared."( The effect of efavirenz on the pharmacokinetics of an oral contraceptive containing ethinyl estradiol and norgestimate in healthy HIV-negative women.
Bertz, R; Eley, T; Garner, D; Krantz, K; Nettles, R; Persson, A; Sevinsky, H; Yones, C; Zhang, J, 2011
)
0.37
"ATV/RTV with dose-normalized EE/NGM resulted in geometric mean reductions of 16% in EE peak plasma concentration (C(max)), 19% in EE area under the concentration-time curve for a dosing interval (AUC([τ])) and 37% in EE lowest plasma concentration (C(min)), compared with EE 35 μg with NGM in the absence of ATV/RTV."( The effect of atazanavir/ritonavir on the pharmacokinetics of an oral contraceptive containing ethinyl estradiol and norgestimate in healthy women.
Bertz, R; Chung, E; Eley, T; Mahnke, L; Persson, A; Xu, X; Yones, C; Zhang, J, 2011
)
0.37
" Dosing with Norgestrel protects photoreceptor cells from undergoing apoptosis in two distinct models of retinal degeneration; the light damage model and the Pde6b(rd10) model."( Enhancing survival of photoreceptor cells in vivo using the synthetic progestin Norgestrel.
Cotter, TG; Doonan, F; Kenna, P; O'Driscoll, C, 2011
)
0.37
"25 mg once daily, n = 32) dosing was initiated on days 11 or 8, respectively, with evening (arm 1) or morning (arm 2) dosing; at steady state (days 15 or 22), a single lomitapide dose was administered; CYP3A inhibitor dosing continued for 6 days."( Evaluation of the effects of the weak CYP3A inhibitors atorvastatin and ethinyl estradiol/norgestimate on lomitapide pharmacokinetics in healthy subjects.
Dutta, S; Foulds, P; King, A; Korb, S; Patel, G; Sumeray, M; Wade, JR, 2016
)
0.43
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (2,196)

TimeframeStudies, This Drug (%)All Drugs %
pre-19901478 (67.30)18.7374
1990's400 (18.21)18.2507
2000's200 (9.11)29.6817
2010's97 (4.42)24.3611
2020's21 (0.96)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials492 (21.29%)5.53%
Reviews113 (4.89%)6.00%
Case Studies132 (5.71%)4.05%
Observational2 (0.09%)0.25%
Other1,572 (68.02%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (10)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Multi-Center Oral Contraceptive Pill Use Trial Conducted In an OTC Naturalistic Environment (OPTION) [NCT03559010]Phase 3189 participants (Actual)Interventional2018-04-27Terminated(stopped due to Terminated prematurely due to issues with one of the data collection systems, no impact on subject safety)
Contraceptive Hormones and Women With Cystic Fibrosis: Satisfaction and Effects on Disease [NCT02144246]Phase 15 participants (Actual)Interventional2014-05-31Terminated
A Prospective, Multi-center, Randomized, Cross-over Study to Assess the Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill [NCT03585712]Phase 252 participants (Actual)Interventional2018-07-24Completed
A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of NGM/EE Tablets Manufactured at 2 Different Facilities [NCT02127593]Phase 1101 participants (Actual)Interventional2013-06-30Completed
Open-label, Randomized, Crossover Study to Prove the Bioequivalence Between Opxion® (Levonorgestrel 1.5 mg Coated Tablet From Bayer de Mexico) and Postinor 2® (Levonorgestrel 1.5 mg Tablet From Biofarma Natural CMD) in Healthy Volunteers [NCT01073904]Phase 132 participants (Actual)Interventional2009-09-30Completed
Modulation Of Putative Surrogate Endpoint Biomarkers In Endometrial Biopsies From Women With HNPCC [NCT00033358]Phase 252 participants (Actual)Interventional2002-02-28Completed
Effects of Different Progesterone Containing Contraceptive Methods on Safety and Endogenous Progesterone Level [NCT05742503]80 participants (Actual)Observational [Patient Registry]2021-03-30Completed
Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS) [NCT04112095]Phase 3962 participants (Actual)Interventional2019-09-06Completed
Phase II Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Ovarian Epithelium in Women at High Risk for Ovarian Cancer [NCT00445887]Phase 260 participants (Actual)Interventional2008-03-10Completed
The Effect of the Co-administration of Atazanavir (ATV) and Ritonavir (RTV) on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects [NCT00357604]Phase 122 participants Interventional2006-07-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00445887 (5) [back to overview]Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue
NCT00445887 (5) [back to overview]Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue
NCT00445887 (5) [back to overview]Patients With High Expression of Transforming Growth Factor-beta 1
NCT00445887 (5) [back to overview]Proportion of Proliferation as Measured by Ki-67
NCT00445887 (5) [back to overview]Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0
NCT03559010 (1) [back to overview]Safety Population: Number of Pregnancies Reported During the Course of the Study
NCT03585712 (3) [back to overview]Duration of Protective Effect of Cervical Mucus After a 6h Delayed or a Missed Pill
NCT03585712 (3) [back to overview]Effect of Delayed Intake or Missed Pill on Cervical Mucus Score (CMS)
NCT03585712 (3) [back to overview]Effect of Delayed Intake or Missed Pill on Cervical Mucus Score (CMS)

Median Proportion Cells That Are Apoptotic in Epithelial Ovarian Tissue

The median proportion of cells that are considered to be apoptotic are counted in the ovarian tissue sample, among the total number of cells available in the sample slide. (NCT00445887)
Timeframe: Surgical specimen (4 - 6 weeks after entry)

Interventionproportion of total cells (Median)
Arm I (Levenorgestrel).093
Arm II (Placebo).115

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Median Proportion Cells That Are Apoptotic in Fallopian Tube Tissue

The median proportion of cells that are considered to be apoptotic are counted in the fallopian tube tissue sample, among the total number of cells available in the sample slide (NCT00445887)
Timeframe: Surgical specimen (4-6 weeks after entry)

Interventionproportion of total cells (Median)
Arm I (Levenorgestrel).205
Arm II (Placebo).079

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Patients With High Expression of Transforming Growth Factor-beta 1

(NCT00445887)
Timeframe: Baseline to time of surgery (4 to 6 weeks)

InterventionParticipants (Count of Participants)
Arm I (Levenorgestrel)6
Arm II (Placebo)3

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Proportion of Proliferation as Measured by Ki-67

(NCT00445887)
Timeframe: Time of surgery (4 to 6 weeks after entry)

InterventionProportion of cells exhibiting Ki-67 (Median)
Arm I (Levenorgestrel).003
Arm II (Placebo).008

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Number of Participants With Adverse Events According to Grade as Determined by NCI CTCAE v.3.0

Participants were graded using CTCAE v.30 criteria. Grade 1 is the least severe grade. Each adverse event lists criteria for grading, grade 1 being mild, up to grade 5. Grade 4 is generally life threatening. Grade 5 is death. (NCT00445887)
Timeframe: Up to 20 weeks

,,,,,,,,,
InterventionParticipants (Count of Participants)
Allergy/ImmunologyConstitutional SymptomsCardiacDermatology/SkinEndocrineGastrointestinalRenal/GenitourinaryHemorrhage/BleedingBlood/Bone MarrowInfectionMetabolic/LaboratoryNeurologyPulmonary/Upper RespiratoryPainSexual/Reproductive Function
Grade 1 CTCAE 3.0 Arm II (Placebo)000120013021021
Grade 1 CTCAE v 3.0 Arm I (Levonorgestrel)111211235020133
Grade 2 CTCAE 3.0 Arm II (Placebo)110011001100020
Grade 2 CTCAE v 3.0 Arm 1 (Levonorgestrel)000000002000010
Grade 3 CTCAE 3.0 Arm II (Placebo)000000000000000
Grade 3 CTCAE v 3.0 Arm 1 (Levonorgestrel)000000000100000
Grade 4 CTCAE 3.0 Arm II (Placebo)000000000000000
Grade 4 CTCAE v3.0 Arm 1 Levonorgestrel)000000000000000
Grade 5 CTCAE 3.0 Arm II (Placebo)000000000000000
Grade 5 CTCAE v3.0 Arm I (Levonorgestrel)000000000000000

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Safety Population: Number of Pregnancies Reported During the Course of the Study

Number of pregnancies reported during the course of the study Measurement tool: phone interview (NCT03559010)
Timeframe: Up to 16 weeks

Interventionparticipants (Number)
Use Phase Norgestrel 0.075 mg1

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Duration of Protective Effect of Cervical Mucus After a 6h Delayed or a Missed Pill

"Subjects are classified according to the risk of losing cervical mucus protection after a 6h delayed or a missed pill, on the day of the infringement and on the day after A cervical mucus score (CMS) <5 is considered as a protective score~Full protection: CMS stay <5 after both a delayed or a missed pill, on the day of infringement and on the day after.~Absence of risk increase: CMS stay <5 on the day of infringement and on the day after.~Transient risk increase: CMS increase >=5 on the day of infringement but go back to <5 on the day after.~Prolonged risk increase: CMS increase >=5 on the day of infringement and stay >=5 on the day after." (NCT03585712)
Timeframe: Day 41 +/- 3 day to Day 43 +/3 days and Day 69 +/- 3 days to Day 71 +/-3 days

,
InterventionParticipants (Count of Participants)
Full ProtectionAbsence of risk increaseTransient risk increaseProlonged risk increase
Delayed Pill Intake303851
Missed Pill Intake303740

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Effect of Delayed Intake or Missed Pill on Cervical Mucus Score (CMS)

"Difference in Cervical Mucus Score between baseline (as Day 41 or Day 69) and delayed (Day 42 and Day 70) or missed pill (Day 43 or day 71)~The Insler cervical mucus score (0-12) is the sum of 4 subscores:~viscosity from 0 (thick, highly viscous) to 3 (watery,minimally viscous)~ferning from 0 (no crystallization) to 3 (tertiary and quaternary stem ferning)~spinnbarkeit from 0 (<1 cm) to 3 (>= 9 cm)~rank for cells from 0 (>20 cells per High Power Field or >1000 cells per μL) to 3 (0 cell)~A score <5 is considered as a protective score while a score >9 is considered as a non protective score" (NCT03585712)
Timeframe: Day 41 +/- 3 day to Day 43 +/3 days and Day 69 +/- 3 days to Day 71 +/-3 days

Interventionchanges in scores on a scale (Least Squares Mean)
Difference in CMs after a 3-hour late pillDifference in CMS between 3h delay and next pill 18h later
Delayed Pill Intake1.00.3

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Effect of Delayed Intake or Missed Pill on Cervical Mucus Score (CMS)

"Difference in Cervical Mucus Score between baseline (as Day 41 or Day 69) and delayed (Day 42 and Day 70) or missed pill (Day 43 or day 71)~The Insler cervical mucus score (0-12) is the sum of 4 subscores:~viscosity from 0 (thick, highly viscous) to 3 (watery,minimally viscous)~ferning from 0 (no crystallization) to 3 (tertiary and quaternary stem ferning)~spinnbarkeit from 0 (<1 cm) to 3 (>= 9 cm)~rank for cells from 0 (>20 cells per High Power Field or >1000 cells per μL) to 3 (0 cell)~A score <5 is considered as a protective score while a score >9 is considered as a non protective score" (NCT03585712)
Timeframe: Day 41 +/- 3 day to Day 43 +/3 days and Day 69 +/- 3 days to Day 71 +/-3 days

Interventionchanges in scores on a scale (Least Squares Mean)
Difference in CMs after a 6-hour late pillDifference in CMs after a 24-hour late pill (missed pill)
Missed Pill Intake0.70.1

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