Page last updated: 2024-12-11

etonogestrel

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

Cross-References

ID SourceID
PubMed CID6917715
CHEMBL ID1531
CHEBI ID50777
SCHEMBL ID117703
MeSH IDM0130651

Synonyms (74)

Synonym
org-3236
etonogestrel ,
13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one
(17-alpha)-13-ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one
18,19-dinor-17alpha-pregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-11-methylene-
3-keto-desogestrel
13-ethyl-11-methylene-18,19-dinor-17-alpha-pregn-4-en-20-yn-3-one
(17alpha)-13-ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-one
17-ethinyl-17-beta-hydroxy-18-methyl-11-methylene-4-estren-3-one
einecs 258-936-2
implanon
18,19-dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-11-methylene-, (17-alpha)-
org 3236
etonogestrel (usan/inn)
implanon (tn)
54048-10-1
D04104
CHEBI:50777 ,
etonogestrelum
17alpha-ethynyl-17beta-hydroxy-11-methylidene-18a-homo-estr-4-en-3-one
3-ketodesogestrel
3-oxodesogestrel
DB00294
3-oxo desogestrel
nexplanon
CHEMBL1531
(8s,9s,10r,13s,14s,17r)-13-ethyl-17-ethynyl-17-hydroxy-11-methylidene-2,6,7,8,9,10,12,14,15,16-decahydro-1h-cyclopenta[a]phenanthren-3-one
tox21_112638
dtxcid7026782
dtxsid9046782 ,
cas-54048-10-1
(17-alpha)-13-ethyl-17-hydroxy-11-methylene-18,19-dinorpregn-4-en-20-yn-3-on
A829925
S4673
etonogestrel [usan:inn:ban]
unii-304gth6rnh
304gth6rnh ,
bdbm50423516
etonogestrel [usp-rs]
etonogestrel [mi]
etonogestrel [who-dd]
etonogestrel component of nuvaring
desogestrel impurity d [ep impurity]
etonogestrel [usan]
18,19-dinor-17.alpha.-pregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-11-methylene-
etonogestrel [inn]
etonogestrel [vandf]
nuvaring component etonogestrel
13-ethyl-11-methylene-18,19-dinor-17alpha-pregn-4-en-20-yn-17-ol-3-one
desogestrel impurity d
etonogestrel [mart.]
etonogestrel [orange book]
HY-B0652
gtpl7590
SCHEMBL117703
(1s,2r,10s,11s,14r,15s)-15-ethyl-14-ethynyl-14-hydroxy-17-methylidenetetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-5-one
AKOS030526156
etonogestrel, united states pharmacopeia (usp) reference standard
(1r,3as,3bs,9ar,9bs,11as)-11a-ethyl-1-ethynyl-1-hydroxy-10-methylidene-1h,2h,3h,3ah,3bh,4h,5h,7h,8h,9h,9ah,9bh,10h,11h,11ah-cyclopenta[a]phenanthren-7-one
AS-73246
etonogestrel, >=98% (hplc)
13-ethyl-17-hydroxy-11-methylidene-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one (3-ketodesogestrel)
(8s,9s,13s,14s,17r)-13-ethyl-17-ethynyl-17-hydroxy-11-methylene-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1h-cyclopenta[a]phenanthren-3(2h)-one
Q3733839
BCP28481
CCG-267753
NCGC00168777-04
C75537
18,19-dinorpregn-4-en-20-yn-3-one,13-ethyl-17-hydroxy-11-methylene-, (17a)-
EN300-19767790
etonogestrel (mart.)
etonogestrel (usp-rs)
g03ac08
desogestrel impurity d (ep impurity)

Research Excerpts

Overview

Etonogestrel (ENG) is a progestin used in the contraceptive vaginal ring NuvaRing and the subdermal implant Implanon.

ExcerptReferenceRelevance
"Etonogestrel (ENG) is a progestin used in the contraceptive vaginal ring NuvaRing and the subdermal implant Implanon. "( A UPLC-MS/MS method for therapeutic drug monitoring of etonogestrel.
Abildskov, KM; Cremers, S; Petrie, K; Shim, J; Thomas, T; Westhoff, CL, 2013
)
2.08
"Etonogestrel (ENG) implant is an effective method of contraception. "( Menstrual bleeding patterns in adolescents using etonogestrel (ENG) implant.
Deokar, AM; Jackson, W; Omar, HA, 2011
)
2.07
"Etonogestrel is a well tolerated, third generation progestagen. "( Implanon. The new alternative.
Cherry, S, 2002
)
1.76

Effects

ExcerptReferenceRelevance
"The etonogestrel implant has been available in Australia since 2001. "( Etonogestrel implants - case studies of median nerve injury following removal.
Gillies, R; Nicklin, S; Scougall, P, 2011
)
2.37

Toxicity

The etonogestrel contraceptive implant remains a safe and effective method of contraception for this specific population, with no increase in graft-related complications among contraceptive implant users. A minority of respondents correctly classified the progestin-only pill, depot medroxyprogesterone acetate, the etonogsestrel implant and the copper intrauterine device as safe to use during lactation.

ExcerptReferenceRelevance
" The most common drug-related adverse event was headache (7%)."( A 4-year pilot study on the efficacy and safety of Implanon, a single-rod hormonal contraceptive implant, in healthy women in Thailand.
Bennink, HJ; Kiriwat, O; Koetsawang, S; Korver, T; Patanayindee, A, 1998
)
0.3
"This integrated analysis evaluates nonmenstrual adverse events, blood pressure, and body weight changes during the use of the single-rod etonogestrel-containing contraceptive implant, Implanon; these aspects are compared for Implanon and Norplant, the six-capsule implant containing levonorgestrel."( An integrated analysis of nonmenstrual adverse events with Implanon.
Urbancsek, J, 1998
)
0.5
"2%) and adverse experiences in the third year (3."( A multicentre efficacy and safety study of the single contraceptive implant Implanon. Implanon Study Group.
Coelingh Bennink, H; Croxatto, HB; Massai, R; Urbancsek, J; van Beek, A, 1999
)
0.3
" Safety was assessed through adverse experiences (AEs), laboratory tests and physical and gynecologic examinations."( Safety and efficacy of Implanon, a single-rod implantable contraceptive containing etonogestrel.
Archer, DF; Funk, S; Miller, MM; Mishell, DR; Poindexter, A; Schmidt, J; Zampaglione, E, 2005
)
0.55
"To determine adverse events and discontinuation of Implanon in healthy Thai women between 16 and 45 years of age."( One year study of Implanon on the adverse events and discontinuation.
Chaovisitsaree, S; Morakote, N; Noium, S; Piyamongkol, W; Pongsatha, S; Soonthornlimsiri, N, 2005
)
0.33
"Determination of adverse events was done three months after Implanon insertion."( One year study of Implanon on the adverse events and discontinuation.
Chaovisitsaree, S; Morakote, N; Noium, S; Piyamongkol, W; Pongsatha, S; Soonthornlimsiri, N, 2005
)
0.33
"1%) were the most menstrual adverse events."( One year study of Implanon on the adverse events and discontinuation.
Chaovisitsaree, S; Morakote, N; Noium, S; Piyamongkol, W; Pongsatha, S; Soonthornlimsiri, N, 2005
)
0.33
" It produced similar adverse events like other progestin-only contraceptives."( One year study of Implanon on the adverse events and discontinuation.
Chaovisitsaree, S; Morakote, N; Noium, S; Piyamongkol, W; Pongsatha, S; Soonthornlimsiri, N, 2005
)
0.33
"The analysis of adverse events revealed two crucial points for acceptability, compliance and continuation: poor cycle control and disturbance of sexual intercourse due to vaginal dryness and loss of desire."( Comparison profiles of cycle control, side effects and sexual satisfaction of three hormonal contraceptives.
Cagiano, R; Sabatini, R, 2006
)
0.33
" Assessments included reports of adverse events (AEs), reasons and rates of discontinuation, insertion/removal complications, and the condition of the implant site."( Tolerability and clinical safety of Implanon.
Blumenthal, PD; Gemzell-Danielsson, K; Marintcheva-Petrova, M, 2008
)
0.35
"7%; the most frequently reported reasons for discontinuation were adverse events (13."( Tolerability and clinical safety of Implanon.
Blumenthal, PD; Gemzell-Danielsson, K; Marintcheva-Petrova, M, 2008
)
0.35
"Implanon is a well-tolerated and safe method of long-acting hormonal contraception for women."( Tolerability and clinical safety of Implanon.
Blumenthal, PD; Gemzell-Danielsson, K; Marintcheva-Petrova, M, 2008
)
0.35
" Safety was primarily assessed by incidence of adverse events."( Safety and efficacy of a single-rod etonogestrel implant (Implanon): results from 11 international clinical trials.
Darney, P; Kaunitz, AM; Patel, A; Rosen, K; Shapiro, LS, 2009
)
0.63
" Common drug-related adverse events were headache, weight gain, acne, breast tenderness, emotional lability, and abdominal pain."( Safety and efficacy of a single-rod etonogestrel implant (Implanon): results from 11 international clinical trials.
Darney, P; Kaunitz, AM; Patel, A; Rosen, K; Shapiro, LS, 2009
)
0.63
"The ENG implant is an efficacious and safe method of contraception which does not require patients' consistent action."( Safety and efficacy of a single-rod etonogestrel implant (Implanon): results from 11 international clinical trials.
Darney, P; Kaunitz, AM; Patel, A; Rosen, K; Shapiro, LS, 2009
)
0.63
"Implanon was an effective, safe and acceptable method of contraception amongst its acceptors."( Safety, efficacy and acceptability of implanon a single rod implantable contraceptive (etonogestrel) in University of Benin Teaching Hospital.
Aisien, AO; Enosolease, ME, 2010
)
0.58
" Overall low rates of adverse effects such as pain, bleeding, infection and perforation, are documented to occur in all studies regardless of the timing or route of IUC insertion."( Immediate post-partum initiation of intrauterine contraception and implants: a review of the safety and guidelines for use.
Black, KI; Mwalwanda, CS, 2013
)
0.39
"Once-monthly NuvaRing is efficacious and safe for use in Chinese women."( Efficacy and safety of the contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive in Chinese women: a 1-year randomised trial.
Chang, Q; Di, W; Fan, GS; Korver, T; Marintcheva-Petrova, M; McCrary Sisk, C; Qin, Y; Ren, M; Su, P; Wang, G; Wu, S; Yacik, C, 2016
)
0.43
"The objective was to determine the association between use of intrauterine devices (IUDs) by young women and risk of adverse outcomes."( The safety of intrauterine devices among young women: a systematic review.
Curtis, KM; Jatlaoui, TC; Riley, HEM, 2017
)
0.46
"Overall evidence suggests that the risk of adverse outcomes related to pregnancy, perforation, infection, heavy bleeding or removals for bleeding among young IUD users is low and may not be clinically meaningful."( The safety of intrauterine devices among young women: a systematic review.
Curtis, KM; Jatlaoui, TC; Riley, HEM, 2017
)
0.46
"3%) and discomfort due to bleeding alterations and other adverse effects (25."( Influence of age on tolerability, safety and effectiveness of subdermal contraceptive implants.
Castillo Cañadas, AM; García Santos, F; Gómez García, MT; González de Merlo, G; González Mirasol, E; López Del Cerro, E; Serrano Diana, C, 2018
)
0.48
" A minority of respondents correctly classified the progestin-only pill, depot medroxyprogesterone acetate, the etonogestrel implant, the levonorgestrel intrauterine system and the copper intrauterine device as safe to use during lactation [14/56 (25%), 24/56 (43%), 27/56 (48%), 19/55 (35%) and 9/55 (16%), respectively]."( An exploratory study of the perception of contraceptive safety and impact on lactation among postpartum nurses at Women and Infants Hospital in 2017.
Allen, RH; Cohen, KE; Has, P; Matteson, KA, 2019
)
0.73
" We also evaluated implant-related side effect profiles and continuation rates among cases only."( Etonogestrel contraceptive implant uptake and safety among solid organ transplant recipients.
Lazorwitz, A; Lew, J; Sheeder, J, 2021
)
2.06
" When compared to age and transplant organ-matched controls, contraceptive implant users were not at increased risk for adverse transplant-related outcomes."( Etonogestrel contraceptive implant uptake and safety among solid organ transplant recipients.
Lazorwitz, A; Lew, J; Sheeder, J, 2021
)
2.06
"This study provides the first data that the etonogestrel contraceptive implant is likely a safe contraceptive option for reproductive-age women who are solid organ transplant recipients."( Etonogestrel contraceptive implant uptake and safety among solid organ transplant recipients.
Lazorwitz, A; Lew, J; Sheeder, J, 2021
)
2.33
" The etonogestrel contraceptive implant remains a safe and effective method of contraception for this specific population, with no increase in graft-related complications among contraceptive implant users."( Etonogestrel contraceptive implant uptake and safety among solid organ transplant recipients.
Lazorwitz, A; Lew, J; Sheeder, J, 2021
)
2.58

Pharmacokinetics

This paper reviews pharmacokinetic and pharmacodynamic studies with Implanon. We aimed to evaluate the effects of a short course (2 weeks) of rifampin on serum etonogestrel (ENG) concentrations and serologic measures of ovarian activity.

ExcerptReferenceRelevance
" Basic pharmacokinetic parameters, like Cmax, tmax and AUC, as well as the serum protein binding of 3-keto-desogestrel were determined on days 1, 10 and 21 of the first and the third treatment cycle, respectively."( Pharmacokinetics and serum protein binding of 3-keto-desogestrel in women during three cycles of treatment with a low-dose combination oral contraceptive.
al-Yacoub, G; Back, DJ; Jütting, G; Kuhnz, W; Ormesher, SE; Power, J, 1992
)
0.28
" The results on serum protein binding of KDG can help researchers interpret overall pharmacokinetic changes."( Pharmacokinetics and serum protein binding of 3-keto-desogestrel in women during three cycles of treatment with a low-dose combination oral contraceptive.
al-Yacoub, G; Back, DJ; Jütting, G; Kuhnz, W; Ormesher, SE; Power, J, 1992
)
0.28
" Goethe University in Frankfurt am Main, Germany, compared serum data on 34 20-39 year old women who used either the oral contraceptive Marvelon (30 mcg ethinyl estradiol [EE] and 150 mcg desogestrel [DG] or Lovelle (20 mcg EE and 150 mcg DG) to observe their pharmacokinetics and some pharmacodynamic parameters."( Oral contraceptives containing 20 or 30 micrograms ethinylestradiol and 150 micrograms desogestrel: pharmacokinetics and pharmacodynamic parameters.
Fitzner, M; Jung-Hoffmann, C; Kuhl, H, 1991
)
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
"The pharmacodynamic effects of a new type of 3-keto-Desogestrel [3kDOG] releasing vaginal ring was studied in a group of 20 normally ovulating women during a period of 21 days continuous use."( Pharmacodynamics of a contraceptive vaginal ring releasing 3-keto-desogestrel.
Jackson, R; Newton, JR, 1989
)
0.28
"To demonstrate that pharmacokinetic measurements were made at steady state."( Pharmacokinetics of a triphasic oral contraceptive containing desogestrel and ethinyl estradiol.
Archer, DF; Lammers, P; Timmer, CJ, 1994
)
0.29
" The statistical analysis on Cmax, AUC, Css,min, and Tmax indicated that the pharmacokinetics of ethinyl E2 on days 7, 14, and 21 were not statistically significantly different, indicating dose equivalency."( Pharmacokinetics of a triphasic oral contraceptive containing desogestrel and ethinyl estradiol.
Archer, DF; Lammers, P; Timmer, CJ, 1994
)
0.29
" The half-life of elimination was 25 hours--significantly lower than the 41."( Pharmacokinetics of etonogestrel released from the contraceptive implant Implanon.
Huber, J; Schnabel, P; van Beek, A; Wenzl, R, 1998
)
0.62
" Maximum mean serum concentrations (Cmax) amounted to 813 pg/mL and the time (tmax) to reach Cmax was 4 days."( Pharmacokinetics of Implanon. An integrated analysis.
Huber, J; Wenzl, R, 1998
)
0.3
"This paper reviews pharmacokinetic and pharmacodynamic studies with Implanon, which provides serum etonogestrel levels sufficient to inhibit ovulation within 8 h of insertion."( The pharmacokinetics and pharmacodynamics of Implanon, a single-rod etonogestrel contraceptive implant.
Bennink, HJ, 2000
)
0.76
"Two pharmacokinetic studies were performed to investigate whether there is any interaction between etonogestrel or ethinylestradiol released from the combined contraceptive vaginal ring NuvaRing and concomitant treatment with orally administered amoxicillin or doxycycline."( Absence of pharmacokinetic interactions of the combined contraceptive vaginal ring NuvaRing with oral amoxicillin or doxycycline in two randomised trials.
Dogterom, P; Thomsen, T; van den Heuvel, MW, 2005
)
0.55
" Calculation of etonogestrel and ethinylestradiol interaction/control ratios confirmed the absence of pharmacokinetic interactions."( Absence of pharmacokinetic interactions of the combined contraceptive vaginal ring NuvaRing with oral amoxicillin or doxycycline in two randomised trials.
Dogterom, P; Thomsen, T; van den Heuvel, MW, 2005
)
0.67
"The results from these studies demonstrate the absence of pharmacokinetic interactions between etonogestrel and ethinylestradiol released from NuvaRing and the oral antibiotics amoxicillin and doxycycline, suggesting that contraceptive efficacy would also be unaffected."( Absence of pharmacokinetic interactions of the combined contraceptive vaginal ring NuvaRing with oral amoxicillin or doxycycline in two randomised trials.
Dogterom, P; Thomsen, T; van den Heuvel, MW, 2005
)
0.55
" Pharmacokinetic data (AUC, C(max), t(max)) were determined the day before (reference) and after (test) a 14-day period of Ze 117 intake (250 mg twice daily)."( St John's wort extract (Ze 117) does not alter the pharmacokinetics of a low-dose oral contraceptive.
Bauer, S; Brattström, A; Kunter, U; Roots, I; Will-Shahab, L, 2009
)
0.35
" Etonogestrel concentrations were measured at 50-hour intervals through 300 hours postinsertion, then at 3 and 6 months to establish a pharmacokinetic curve."( Pharmacokinetics of the etonogestrel contraceptive implant in obese women.
Chan, LN; Gilliam, M; Martins, S; Mistretta, S; Mornar, S; Neustadt, A, 2012
)
1.6
" We evaluated the effect of 2 highly active antiretroviral therapy (HAART) regimens (1 including efavirenz and the other ritonavir-boosted lopinavir) on the pharmacokinetic (PK) parameters of an ENG-releasing implant in HIV-positive women."( Effect of antiretroviral therapy including lopinavir/ritonavir or efavirenz on etonogestrel-releasing implant pharmacokinetics in HIV-positive women.
Amaral, E; Bahamondes, L; Bahamondes, MV; Brito, MB; de Souza, RM; Duarte, G; Ferriani, RA; Quintana, SM; Rocha Prandini, TR; Scaranari, C; Vieira, CS, 2014
)
0.63
"Sparse pharmacokinetic sampling of ENG, NVP, or EFV were performed at screening, entry, and then 1, 4, 12, and 24-week postimplant insertion."( Efavirenz decreases etonogestrel exposure: a pharmacokinetic evaluation of implantable contraception with antiretroviral therapy.
Achilles, SL; Chappell, CA; Chen, BA; Cohn, SE; Darin, KM; Lamorde, M; Mackline, H; Nakalema, S; Riddler, SA; Scarsi, KK, 2017
)
0.78
"Single centre, open label, phase-2 pharmacokinetic study."( Plasma concentrations of etonogestrel in women using oral desogestrel before and after Roux-en-Y gastric bypass surgery: a pharmacokinetic study.
Ärlemalm, A; Brynhildsen, J; Carlsson, B; Frisk, J; Ginstman, C; Hägg, S, 2019
)
0.82
"Steady-state etonogestrel pharmacokinetic (PK) parameters were measured on three occasions for each individual (at 8 ± 6 weeks before surgery, and at 12 ± 2 and 52 ± 2 weeks after surgery)."( Plasma concentrations of etonogestrel in women using oral desogestrel before and after Roux-en-Y gastric bypass surgery: a pharmacokinetic study.
Ärlemalm, A; Brynhildsen, J; Carlsson, B; Frisk, J; Ginstman, C; Hägg, S, 2019
)
1.19
" Associations between patient genotype and etonogestrel pharmacokinetic parameters were determined through univariate and multivariate linear regression."( Effect of patient genetics on etonogestrel pharmacokinetics when combined with efavirenz or nevirapine ART.
Achilles, SL; Chappell, CA; Chen, BA; Lamorde, M; Matovu, J; Nakalema, S; Neary, M; Owen, A; Scarsi, KK; Siccardi, M, 2019
)
1.07
"Within the control group, CYP2B6 983 T>C was associated with 27% higher etonogestrel Cmax and 28% higher AUC0-24weeks."( Effect of patient genetics on etonogestrel pharmacokinetics when combined with efavirenz or nevirapine ART.
Achilles, SL; Chappell, CA; Chen, BA; Lamorde, M; Matovu, J; Nakalema, S; Neary, M; Owen, A; Scarsi, KK; Siccardi, M, 2019
)
1.03
"We did a parallel, three-group, pharmacokinetic evaluation at HIV clinics in Asia (two sites), South America (five), sub-Saharan Africa (three), and the USA (11) between Dec 30, 2014, and Sept 12, 2016."( Antiretroviral therapy and vaginally administered contraceptive hormones: a three-arm, pharmacokinetic study.
Akelo, V; Aweeka, F; Aziz, M; Berzins, B; Cohn, SE; Coombs, RW; Coughlin, K; Cramer, YS; Friedman, RK; Gingrich, D; Godfrey, C; Moran, LE; Rosenkranz, SL; Scarsi, KK; Swaminathan, S; Zorrilla, CD, 2019
)
0.51
" Further studies designed to examine pharmacodynamic endpoints, such as ovulation, when intravaginal ring hormones are combined with efavirenz are warranted."( Antiretroviral therapy and vaginally administered contraceptive hormones: a three-arm, pharmacokinetic study.
Akelo, V; Aweeka, F; Aziz, M; Berzins, B; Cohn, SE; Coombs, RW; Coughlin, K; Cramer, YS; Friedman, RK; Gingrich, D; Godfrey, C; Moran, LE; Rosenkranz, SL; Scarsi, KK; Swaminathan, S; Zorrilla, CD, 2019
)
0.51
"We confirm that single-time measurements of serum etonogestrel concentration are acceptable pharmacokinetic outcomes for etonogestrel implant studies."( Variability in repeat serum etonogestrel concentrations among contraceptive implant users during the steady-release pharmacokinetic period.
Lazorwitz, A; Sheeder, J; Teal, S, 2022
)
1.27
" Our repeated measures study using modern liquid-chromatography mass-spectrometry analysis methods provides updated support for single-time pharmacokinetic measurements among etonogestrel implant users."( Variability in repeat serum etonogestrel concentrations among contraceptive implant users during the steady-release pharmacokinetic period.
Lazorwitz, A; Sheeder, J; Teal, S, 2022
)
1.21
"Two separate, parallel, three-group, non-randomized, pharmacokinetic studies evaluated either etonogestrel or levonorgestrel in women receiving rilpivirine- or darunavir-based ART compared with women without HIV (control group)."( Pharmacokinetics of levonorgestrel and etonogestrel contraceptive implants over 48 weeks with rilpivirine- or darunavir-based antiretroviral therapy.
Byakika-Kibwika, P; Chappell, CA; Fletcher, CV; Jeppson, J; Kaboggoza, J; Kyohairwe, I; Lamorde, M; Mbabazi, L; Musaazi, J; Nakalema, S; Nakijoba, R; Nassiwa, S; Pham, M; Scarsi, KK; Siccardi, M; Walimbwa, SI; Winchester, L, 2022
)
1.21
" We aimed to evaluate the pharmacokinetic and pharmacodynamic effects of a short course (2 weeks) of rifampin on serum etonogestrel (ENG) concentrations and serologic measures of ovarian activity (endogenous estradiol [E2] and progesterone [P4]) among ENG implant users."( The effect of rifampin on serum etonogestrel concentrations and biomarkers of ovulation among contraceptive implant users: A pharmacokinetic and pharmacodynamic study.
Lazorwitz, A; Sheeder, J; Teal, S, 2023
)
1.4

Compound-Compound Interactions

This study demonstrates the influence of pharmacogenetics on the extent of drug-drug interactions. This study aimed to investigate MENT implants in combination with etonogestrel on spermatogenesis, gonadotropins, and androgen-dependent tissues.

ExcerptReferenceRelevance
"The pharmacokinetics and pharmacodynamics of 150 micrograms desogestrel (DG) or 150 micrograms 3-keto-desogestrel (KDG) in combination with 30 micrograms ethinylestradiol (EE) were compared in a cross-over study."( Prodrug versus drug effects of 150 micrograms desogestrel or 3-keto-desogestrel in combination with 30 micrograms ethinylestradiol on hormonal parameters: relevance of the peak serum level of 3-keto-desogestrel.
Fitzner, M; Jung-Hoffmann, C; Kuhl, H, 1995
)
0.29
"The effects of a synthetic oral progestogen, desogestrel (DSG), administered with low dose testosterone (T) were investigated to determine the optimal combination for suppression of gonadotropins and spermatogenesis to targets compatible with effective male contraception."( Oral progestogen combined with testosterone as a potential male contraceptive: additive effects between desogestrel and testosterone enanthate in suppression of spermatogenesis, pituitary-testicular axis, and lipid metabolism.
Balasubramanian, R; Coelingh-Bennink, HJ; Mulders, TM; Wu, FC, 1999
)
0.3
" This study aimed to investigate MENT implants in combination with etonogestrel on spermatogenesis, gonadotropins, and androgen-dependent tissues in comparison with a testosterone/etonogestrel regimen."( 7alpha-methyl-19-nortestosterone (MENT) vs testosterone in combination with etonogestrel implants for spermatogenic suppression in healthy men.
Anderson, RA; Baird, DT; Kumar, N; Ludlow, H; Walton, MJ,
)
0.6
"To investigate the efficacy, safety, removal characteristics, and x-ray visibility of Nexplanon, a radiopaque etonogestrel contraceptive implant combined with a next-generation applicator."( Nexplanon, a radiopaque etonogestrel implant in combination with a next-generation applicator: 3-year results of a noncomparative multicenter trial.
Blum, GF; Gent, TG; Marintcheva-Petrova, M; Mommers, E; Peters, KP; Sørdal, TS, 2012
)
0.9
"To investigate the genetic contribution to this previously observed drug-drug interaction through studying SNPs in genes known to be involved in efavirenz, nevirapine or etonogestrel metabolism in the same group of women."( Effect of patient genetics on etonogestrel pharmacokinetics when combined with efavirenz or nevirapine ART.
Achilles, SL; Chappell, CA; Chen, BA; Lamorde, M; Matovu, J; Nakalema, S; Neary, M; Owen, A; Scarsi, KK; Siccardi, M, 2019
)
1
"This study demonstrates the influence of pharmacogenetics on the extent of drug-drug interactions between etonogestrel and efavirenz- or nevirapine-based ART."( Effect of patient genetics on etonogestrel pharmacokinetics when combined with efavirenz or nevirapine ART.
Achilles, SL; Chappell, CA; Chen, BA; Lamorde, M; Matovu, J; Nakalema, S; Neary, M; Owen, A; Scarsi, KK; Siccardi, M, 2019
)
1.02
" For patients with adenomyosis who refuse surgery and are not candidates for the use of LNG-IUS, an ENG-releasing implant combined with endometrial ablation may be an effective alternative."( Subcutaneous etonogestrel implant combined with endometrial ablation for the treatment of adenomyosis: two case reports.
Cheng, L; Nie, LK; Zhang, PH; Zou, HL, 2022
)
1.09

Bioavailability

Co-administration with some antiretroviral therapies (ART) changes the bioavailability of the etonogestrel (ENG)-releasing contraceptive implant, possibly affecting the bleeding pattern.

ExcerptReferenceRelevance
" Lower bioavailability of KDG (60-80% vs."( Pharmacokinetics and serum protein binding of gestodene and 3-keto-desogestrel in women after single oral administration of two different contraceptive formulations.
Back, DJ; Kuhnz, W; Power, J; Schütt, B, 1992
)
0.28
"Two low-dose oral contraceptives, both containing the same dose of ethinyl estradiol (EE2) but different progestins (gestodene and desogestrel, respectively), were compared with respect to the relative bioavailability of EE2."( Concentration of ethinyl estradiol in the serum of 31 young women following a treatment period of 3 months with two low-dose oral contraceptives in an intraindividual cross-over design.
Back, D; Kuhnz, W; Louton, T; Power, J; Schütt, B, 1991
)
0.28
" Bioavailability ranged between 40."( Plasma concentrations of 3-keto-desogestrel after oral administration of desogestrel and intravenous administration of 3-keto-desogestrel.
Back, DJ; Grimmer, SF; Orme, ML; Shenoy, N, 1987
)
0.27
" Bioavailability was calculated as the ratio of area under the plasma concentration time curve of the oral to the area under the curve of the iv dose."( Plasma concentrations of 3-keto-desogestrel after oral administration of desogestrel and intravenous administration of 3-keto-desogestrel.
Back, DJ; Grimmer, SF; Orme, ML; Shenoy, N, 1987
)
0.27
", volume of distribution and clearance, allowing the calculation of the absorption rate and bioavailability of the implant, as a function of time."( Pharmacokinetics of etonogestrel released from the contraceptive implant Implanon.
Huber, J; Schnabel, P; van Beek, A; Wenzl, R, 1998
)
0.62
" The absorption rate of about 30 mcg/day after 3 months of use decreased to 30 mcg/day at the end of 2 years."( Pharmacokinetics of etonogestrel released from the contraceptive implant Implanon.
Huber, J; Schnabel, P; van Beek, A; Wenzl, R, 1998
)
0.62
" Implanon had an absorption rate of almost 60 micrograms/day after 3 months, which slowly decreased to 30 micrograms/day at the end of 2 years."( Pharmacokinetics of Implanon. An integrated analysis.
Huber, J; Wenzl, R, 1998
)
0.3
" In comparison with the DSG/EE COC, the absolute bioavailability for NuvaRing was higher for etonogestrel (102."( Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring.
Mulders, TM; Timmer, CJ, 2000
)
0.85
" This delivery system provides many advantages over oral contraceptives (OCs), including avoidance of the first-pass effect through the liver, constant serum steroid levels, longer duration of use, and greater bioavailability of the hormones."( Contraceptive vaginal rings.
Harwood, B; Mishell, DR, 2001
)
0.31
" Because ENG bioavailability was higher following vaginal administration, the systemic progestogen exposures were comparable with the two contraceptives."( Complete and robust ovulation inhibition with NuvaRing.
Killick, S, 2002
)
0.31
" This analytical method was applied in a relative bioavailability study in order to compare a test budesonide 64 μg/dose nasal spray formulation vs."( Budesonide quantification by HPLC coupled to atmospheric pressure photoionization (APPI) tandem mass spectrometry. Application to a comparative systemic bioavailability of two budesonide formulations in healthy volunteers.
Astigarraga, RB; Borges, BC; Borges, NC; Galvinas, PR; Moreno, RA; Paiva, TR; Sverdloff, CE, 2011
)
0.37
"The EFV-based HAART regimen was associated with a reduction in the bioavailability of ENG, which showed decreases of 63."( Effect of antiretroviral therapy including lopinavir/ritonavir or efavirenz on etonogestrel-releasing implant pharmacokinetics in HIV-positive women.
Amaral, E; Bahamondes, L; Bahamondes, MV; Brito, MB; de Souza, RM; Duarte, G; Ferriani, RA; Quintana, SM; Rocha Prandini, TR; Scaranari, C; Vieira, CS, 2014
)
0.63
"The coadministration of EFV decreased the bioavailability of ENG released from the implant, which could impair contraceptive efficacy."( Effect of antiretroviral therapy including lopinavir/ritonavir or efavirenz on etonogestrel-releasing implant pharmacokinetics in HIV-positive women.
Amaral, E; Bahamondes, L; Bahamondes, MV; Brito, MB; de Souza, RM; Duarte, G; Ferriani, RA; Quintana, SM; Rocha Prandini, TR; Scaranari, C; Vieira, CS, 2014
)
0.63
" Co-administration with some antiretroviral therapies (ART) changes the bioavailability of the etonogestrel (ENG)-releasing contraceptive implant, possibly affecting the bleeding pattern."( Bleeding patterns of HIV-infected women using an etonogestrel-releasing contraceptive implant and efavirenz-based or lopinavir/ritonavir-based antiretroviral therapy.
Amaral, E; Bahamondes, L; Bahamondes, MV; Brito, MB; Duarte, G; Ferriani, RA; Prandini, TR; Quintana, SM; Ragazini, CS; Vieira, CS, 2016
)
0.91
" There was no statistical difference between bioavailability of ENG treated with DMNs or ID injections (p >0."( Dissolving Microneedles Loaded With Etonogestrel Microcrystal Particles for Intradermal Sustained Delivery.
Gao, Y; He, M; Yang, G; Zhang, S; Zhao, X, 2018
)
0.76

Dosage Studied

Among new forms of hormonal contraception, three interesting exemples are described with a high level of effectiveness and low dosage regimen. These include a very low-dose estrogen-progestogen combination of ethinylestradiol and gestodene.

ExcerptRelevanceReference
" A dose-response relationship was seen in the endocrine and clinical performance of the CVR."( Clinical performance and endocrine profiles of contraceptive vaginal rings releasing 3-keto-desogestrel and ethinylestradiol.
Alapiessa, U; Apter, D; Assendorp, R; Cacciatore, B; Stenman, UH, 1990
)
0.28
" The individual AUCs for 3-keto-desogestrel after dosing with desogestrel (plus EE) or 3-keto-desogestrel (plus EE) show a similar degree of variation."( Serum levels of 3-keto-desogestrel after oral administration of desogestrel and 3-keto-desogestrel.
Bosch, AM; Hasenack, HG; Käär, K, 1986
)
0.27
" Protection is ensured with a low drug dosage and no estrogen, and fertility is readily reversible once the implants are removed."( Subdermal contraceptive implants.
Croxatto, H; Diaz, S; Peralta, O, 1995
)
0.29
" The serum concentrations of KDG and gestodene during multiple dosing cannot be predicted on the basis of single dose pharmacokinetics."( Pharmacokinetics and protein binding of 3-ketodesogestrel and gestodene in the serum of women during 6 cycles of treatment with two low dose oral contraceptives.
Back, DJ; Daume, E; Hammerstein, J; Neiss, A; Power, J; Schindler, AE; Simon, A; Winkler, U, 1993
)
0.29
" The dosage schedule was 7/7/7, that is, a different dose for each 7-day period."( Pharmacokinetics of a triphasic oral contraceptive containing desogestrel and ethinyl estradiol.
Archer, DF; Lammers, P; Timmer, CJ, 1994
)
0.29
"Among new forms of hormonal contraception, three interesting exemples are described with a high level of effectiveness and low dosage regimen that allow improved safety and tolerance: a very low-dose estrogen-progestogen combination of ethinylestradiol and gestodene for 24-day cyclical administration; a progestogen-alone subcutaneous implant containing etonogestrel; and a levonorgestrel-releasing intrauterine system."( [New forms of hormonal contraception].
Buicu, C; Gaspard, U; van den Brûle, F, 2000
)
0.48
" Subsequently, the single-dose pharmacokinetic parameters of etonogestrel from Cerazette tablets were compared with those after multiple dosing of one Cerazette tablet once daily for 7 days, in a subgroup of 12 subjects (study part 2)."( Bioavailability and bioequivalence of etonogestrel from two oral formulations of desogestrel: Cerazette and Liseta.
Cohen, AF; Dieben, TO; Srivastava, N; Timmer, CJ,
)
0.64
" Different formulations of miconazole nitrate and single as well as multiple dosing were investigated during two separate randomized, open-label, crossover studies."( The contraceptive vaginal ring, NuvaRing, and antimycotic co-medication.
Dieben, TO; Mulders, TM; van den Heuvel, MW; Verhoeven, CH, 2004
)
0.32
" We believe that the observed reduction in the number of bleeding days by almost 50% compared to placebo in both the mifepristone combination group and the doxycycline group demonstrates a clinically significant improvement in bleeding patterns and that further trials are needed to compare different combinations of therapy as well as multiple dosing regimens in order to establish which is the most effective treatment option."( A pilot study to assess the effect of three short-term treatments on frequent and/or prolonged bleeding compared to placebo in women using Implanon.
Findlay, JK; Fraser, IS; Hickey, M; O'Connor, V; Palmer, D; Salamonsen, LA; Weisberg, E, 2006
)
0.33
" Several new contraceptive methods with alternate routes of delivery and less frequent dosing are available."( The combined etonogestrel/ethinyl estradiol contraceptive vaginal ring.
Arias, RD; Nucatola, DL; Wagner, MS, 2007
)
0.71
"To determine whether extended-cycle dosing of an ultralow dose vaginal ring contraceptive decreases frequency of migraine aura and prevents menstrual related migraine (MRM)."( The impact of extended-cycle vaginal ring contraception on migraine aura: a retrospective case series.
Calhoun, A; Ford, S; Pruitt, A, 2012
)
0.38
" With the evolution of increasingly lower dosed combined hormonal contraceptives, we now have formulations that--provided that ovulation is inhibited--result in lower peak levels of estrogen than the concentrations attained during the native menstrual cycle."( The impact of extended-cycle vaginal ring contraception on migraine aura: a retrospective case series.
Calhoun, A; Ford, S; Pruitt, A, 2012
)
0.38
"Combined contraceptive vaginal rings (CVR) are increasingly appreciated due to several beneficial properties like avoidance of the hepatic first-pass effect, a comparatively low dosage of hormones and comfortable use."( Safety, efficacy and quality of life of the novel vaginal contraceptive ring containing etonogestrel/ethinylestradiol 11.0/3.474 mg after 3 years of "real life" experience.
Colli, E; Müller, A; Regidor, PA; Sailer, M, 2020
)
0.78
"Assessment of estrus cyclicity indicated a dose-response relationship in the shift to a larger number of acyclic rats and longer in duration spent in the diestrus phase."( A rodent model of human dose-equivalent progestin-only implantable contraception.
Allaway, HCM; Bloomfield, SA; Invik, J; Pierson, RA, 2021
)
0.62
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
contraceptive drugA chemical substance that prevents or reduces the probability of conception.
progestinA synthetic progestogen.
female contraceptive drugA chemical substance or agent with contraceptive activity in females.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (3)

ClassDescription
17beta-hydroxy steroidA 17-hydroxy steroid in which the hydroxy group at position 17 has a beta-configuration.
3-oxo-Delta(4) steroidA 3-oxo steroid conjugated to a C=C double bond at the alpha,beta position.
terminal acetylenic compoundAn acetylenic compound which a carbon of the C#C moiety is attached to a hydrogen atom.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (10)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
TDP1 proteinHomo sapiens (human)Potency25.14360.000811.382244.6684AID686978; AID686979
AR proteinHomo sapiens (human)Potency2.58200.000221.22318,912.5098AID743035; AID743036; AID743040; AID743042; AID743053; AID743054; AID743063
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency0.37900.000214.376460.0339AID720692
pregnane X nuclear receptorHomo sapiens (human)Potency25.11890.005428.02631,258.9301AID1346985
estrogen nuclear receptor alphaHomo sapiens (human)Potency2.46670.000229.305416,493.5996AID743075; AID743077; AID743079
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency0.01500.001723.839378.1014AID743083
nuclear receptor subfamily 1, group I, member 2Rattus norvegicus (Norway rat)Potency7.94330.10009.191631.6228AID1346983
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency14.33430.000323.4451159.6830AID743065; AID743067
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency39.81070.009610.525035.4813AID1479145
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Sex hormone-binding globulinHomo sapiens (human)Kd0.00590.00020.34964.7863AID318680
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Molecular Functions (3)

Processvia Protein(s)Taxonomy
androgen bindingSex hormone-binding globulinHomo sapiens (human)
protein bindingSex hormone-binding globulinHomo sapiens (human)
steroid bindingSex hormone-binding globulinHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (3)

Processvia Protein(s)Taxonomy
extracellular regionSex hormone-binding globulinHomo sapiens (human)
extracellular exosomeSex hormone-binding globulinHomo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (3)

Assay IDTitleYearJournalArticle
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID318680Displacement of [3H]5alpha dihydrotestosterone from human sex hormone binding globulin2008Journal of medicinal chemistry, Apr-10, Volume: 51, Issue:7
An updated steroid benchmark set and its application in the discovery of novel nanomolar ligands of sex hormone-binding globulin.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (684)

TimeframeStudies, This Drug (%)All Drugs %
pre-19908 (1.17)18.7374
1990's59 (8.63)18.2507
2000's220 (32.16)29.6817
2010's303 (44.30)24.3611
2020's94 (13.74)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 75.40

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

MetricThis Compound (vs All)
Research Demand Index75.40 (24.57)
Research Supply Index6.74 (2.92)
Research Growth Index5.60 (4.65)
Search Engine Demand Index131.90 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (75.40)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials135 (19.09%)5.53%
Reviews98 (13.86%)6.00%
Case Studies102 (14.43%)4.05%
Observational18 (2.55%)0.25%
Other354 (50.07%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (80)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Multicenter, Randomized, Partially Blinded, Placebo-controlled Clinical Trial to Evaluate the Effect on Primary Dysmenorrhea of Vaginal Rings With an Average Daily Release of 700 μg Nomegestrol Acetate (NOMAC) and 300 μg Estradiol (E2), or 900 μg Nomege [NCT01670656]Phase 2439 participants (Actual)Interventional2013-01-21Completed
A Randomized, Double-Blind, Parallel Group, Bioequivalence Study of IMPLANON and Radiopaque IMPLANON [NCT00620464]Phase 3108 participants (Actual)Interventional2005-05-31Completed
A Randomized Controlled Trial of Immediate Versus Delayed Insertion of Implanon in Postpartum Adolescents [NCT03585504]Phase 381 participants (Actual)Interventional2010-01-31Completed
A Phase 3, Open-label, Multi-center, Single Arm Study to Assess Contraceptive Efficacy and Safety of the Etonogestrel (MK-8415) Implant During Extended Use From 3 Years After Insertion in Females 35 Years of Age or Younger [NCT04626596]Phase 3495 participants (Actual)Interventional2020-11-19Active, not recruiting
A Phase 3, Randomized, Active-Comparator Controlled Clinical Trial to Study the Contraceptive Efficacy and Safety of the MK-8342B (Etonogestrel + 17β-Estradiol) Vaginal Ring and the Levonorgestrel-Ethinyl Estradiol (LNG-EE) 150/30 μg Combined Oral Contrac [NCT02616146]Phase 32,016 participants (Actual)Interventional2015-12-01Terminated(stopped due to Study terminated by Sponsor as a result of a business decision to discontinue the development program for MK-8342B for reasons unrelated to safety or efficacy.)
Etonogestrel Implant or Depot Medroxyprogesterone Acetate for Medication Abortion [NCT01356927]40 participants (Actual)Observational2011-05-31Completed
A Randomized, Multicenter, Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Doses of an Etonogestrel-releasing Medicated Intrauterine System (ENG-MIUS) Versus a Copper-releasing Intrauterine Device (IUD) [NCT00967746]Phase 284 participants (Actual)Interventional2009-11-30Completed
A Pharmacokinetic Evaluation of Etonogestrel (ENG) Implant and Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Based Antiretroviral Therapy in HIV-Infected Ugandan Women [NCT02082652]Phase 460 participants (Actual)Interventional2014-10-31Completed
Phase II, Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Efficacy and Safety of Org 3236 Tablets in Men With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia (BPH) [NCT00651807]Phase 216 participants (Actual)Interventional2008-03-31Terminated(stopped due to Business Reasons)
AFTER: Application for the Etonogestrel/Ethinyl Estradiol Ring--potential for Emergency Contraception [NCT03120728]Phase 436 participants (Anticipated)Interventional2017-07-10Recruiting
Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study [NCT05227456]Phase 297 participants (Anticipated)Interventional2022-07-01Recruiting
A Phase II -b, Placebo-Controlled Trial Investigating the Efficacy, Safety and Pharmacokinetics of a Subcutaneous Etonogestrel Implant Combined With i.m. Testosterone Undecanoate for Male Contraception [NCT00403793]Phase 2350 participants (Actual)Interventional2003-10-31Completed
Predictors of Abnormal Uterine Bleeding in Progestin-only Contraceptives Users [NCT03398811]390 participants (Actual)Observational2018-08-01Completed
Antepartum Etonogestrel Contraceptive Implant Insertion at Term: an Acceptability and Pharmacokinetic Pilot Study [NCT03656289]Phase 10 participants (Actual)Interventional2019-01-01Withdrawn(stopped due to IND approval from FDA was rejected and IRB approval was never granted.)
Nexplanon Use in Women Primarily Choosing a Combined Hormonal Contraceptive: a Proof of Concept Trial [NCT02852265]Phase 420 participants (Actual)Interventional2016-09-15Completed
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Study the Efficacy and Safety of MK-8342B (ENG-E2 Vaginal Ring) in Women With Moderate to Severe Primary Dysmenorrhea (With Optional Extension) [NCT02668783]Phase 325 participants (Actual)Interventional2016-02-11Terminated(stopped due to Study terminated by Sponsor as a result of a business decision to discontinue the development program for MK-8342B for reasons unrelated to safety or efficacy.)
A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®) [NCT00725413]Phase 4210 participants (Actual)Interventional2001-11-30Completed
An Open-Label, Non-Controlled Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator [NCT00620035]Phase 3301 participants (Actual)Interventional2007-03-31Completed
HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC [NCT02038335]451 participants (Actual)Observational2014-02-28Completed
Effectiveness of Prolonged Use of IUD/Implant for Contraception [NCT02267616]1,076 participants (Actual)Interventional2011-12-31Completed
Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant [NCT03353012]Phase 460 participants (Actual)Interventional2018-01-01Completed
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum [NCT00042289]1,578 participants (Actual)Observational2003-06-09Completed
Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial [NCT02866279]155 participants (Actual)Interventional2016-11-30Completed
The Effect of Dolutegravir-based ART on Plasma Etonogestrel Levels in HIV-infected Women Using Contraceptive Implants in Botswana [NCT03336346]148 participants (Actual)Observational2017-11-15Completed
A Phase 1 Clinical Trial to Evaluate the Pharmacokinetics, Removability, Safety, and Tolerability of Casea S Contraceptive Implants [NCT05174884]Phase 130 participants (Anticipated)Interventional2023-11-30Not yet recruiting
Evaluation of Female Sexual Functions in Progestogen-only Contraceptive Users [NCT02579590]444 participants (Actual)Observational2017-05-01Completed
A Pilot Prospective, Randomized Pharmacodynamic Study With Assessment of Ulipristal Acetate on Ovarian Activity Following Quickstart of the Etonogestrel Contraceptive Implant [NCT04291001]Early Phase 140 participants (Actual)Interventional2020-09-04Active, not recruiting
Real-world Duration of Use for Highly Effective Reversible Contraception (HERC): A Retrospective Review [NCT02414919]13,880 participants (Actual)Observational2015-04-01Completed
The Impact of Different Administration Routes of Hormonal Contraceptives on Androgen Synthesis, Glucose Metabolism and Inflammation. A Prospective Randomized Trial. [NCT01087879]45 participants (Anticipated)Interventional2007-10-31Completed
A Multicenter Prospective Randomized Controlled Clinical Study of Etonogestrel Implants to Protect Ovarian Reserve Function in Systemic Lupus Erythematosus [NCT05791799]Phase 2/Phase 3180 participants (Anticipated)Interventional2023-04-01Not yet recruiting
Evaluation of a Subcutaneous Progestogen Implants in the Medical Management of Painful Endometriosis [NCT02669238]Phase 2/Phase 32 participants (Actual)Interventional2018-05-25Terminated(stopped due to insufficient recruitment)
A Prospective Observational Clinical Trial to Compare the Effect of Immediate Postpartum Nexplanon Placement Versus Standard Postpartum Contraceptive Care on Consistent Contraceptive Use and Rapid Repeat Pregnancy in Opioid Dependent Women. [NCT02657148]200 participants (Actual)Observational2016-05-31Completed
Long-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy [NCT01299116]Phase 4916 participants (Actual)Interventional2011-12-31Completed
Use of Etonogestrel-releasing Contraceptive Implant in Women With Sickle Cell Disease [NCT02594462]Phase 429 participants (Actual)Interventional2015-01-31Completed
The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health [NCT00612508]14 participants (Actual)Interventional2007-05-31Completed
The Effect of 30mcg and Levonorgestrel 150 Combined Oral Contraceptive, Etonogestrel-releasing Subdermal Implant and Levonorgestrel-releasing Intrauterine System on Breast-Milk Production and Infant Growth in Fully Breast-Feeding Women [NCT01388582]Phase 440 participants (Actual)Interventional2011-04-30Completed
Multicenter, Open-label, Randomized, Controlled Parallel-group Study to Assess Discontinuation Rates, Bleeding Patterns, User Satisfaction and Adverse Event Profile of LCS12 in Comparison to Etonorgestrel Subdermal Implant Over 12 Months of Use in Women 1 [NCT01397097]Phase 3766 participants (Actual)Interventional2011-09-30Completed
Acceptability of Long-term Progestin-only Contraception in Europe [NCT00931827]436 participants (Actual)Observational2008-01-31Completed
Early Versus Delayed Insertion of Nexplanon® at Medical Abortion - a Randomized Controlled Equivalence Trial. [NCT01920022]Phase 4551 participants (Actual)Interventional2013-10-31Completed
Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives [NCT05044962]700 participants (Anticipated)Interventional2021-11-26Recruiting
Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS [NCT04257500]Phase 440 participants (Anticipated)Interventional2020-06-24Recruiting
The Effects of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) on Vaginal Innate and Inflammatory Biomarkers [NCT01448291]Phase 430 participants (Anticipated)Interventional2011-10-31Recruiting
An Open-Label, Randomized, Multicenter Trial to Evaluate Continuation Rates, Side Effects and Acceptability of NuvaRing Versus OrthoEvra [NCT00269620]Phase 4500 participants (Actual)Interventional2005-06-30Completed
Pharmacokinetic and Pharmacodynamic Evaluation of Etonogestrel Dose Escalation With Efavirenz-based Antiretroviral Therapy in HIV-infected Ugandan [NCT03282799]Phase 272 participants (Actual)Interventional2019-02-19Completed
Etonogestrel Implant as Emergency Contraception: A Pilot Pharmacodynamic Study [NCT05237141]Phase 412 participants (Anticipated)Interventional2022-04-01Recruiting
An Observational Pharmacokinetic Study to Evaluate Drug-drug Interactions Between Doravirine-containing ART and Hormonal Contraceptives Among Women Living With HIV in South Africa. [NCT04669678]Phase 4105 participants (Anticipated)Interventional2021-11-17Recruiting
Effect of Immediate Versus Standard Postpartum Insertion of the Contraceptive Implant on Breastfeeding Outcomes [NCT03978598]Phase 4150 participants (Actual)Interventional2019-06-03Active, not recruiting
The Frequency and Management of Breakthrough Bleeding During Extended Therapy With the Transvaginal Contraceptive Ring [NCT00475553]75 participants (Actual)Interventional2006-05-31Completed
Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant [NCT00847587]Phase 469 participants (Actual)Interventional2009-01-31Completed
Endometrial Biopsy in Progestin Contraceptive Users [NCT05760144]Early Phase 152 participants (Anticipated)Interventional2023-07-01Recruiting
An Open-label, Randomized, 2-Period, Crossover Study to Assess the Comparative Pharmacokinetics of LSP-5415 and NuvaRing® in Healthy Adult Females [NCT05360576]Phase 240 participants (Actual)Interventional2022-02-24Completed
A Pharmacokinetic Evaluation of Etonogestrel Implant in HIV-infected Women on Darunavir Versus Ripilvirine-based Antiretroviral Therapy [NCT03589040]Phase 260 participants (Anticipated)Interventional2018-09-25Recruiting
Immediate vs. Delayed Insertion of Nexplanon After Termination of Pregnancy Over 14-weeks Gestation (NAPA) [NCT02037919]150 participants (Actual)Interventional2014-06-30Active, not recruiting
Effects of Different Progesterone Containing Contraceptive Methods on Safety and Endogenous Progesterone Level [NCT05742503]80 participants (Actual)Observational [Patient Registry]2021-03-30Completed
Assessing Ovarian Function During Prolonged Implant Use [NCT03058978]117 participants (Actual)Observational2017-03-01Completed
The Rate and Predictors of Amenorrhea at 1-year Follow-up in Women Using Etonogestrel Implant [NCT05040282]300 participants (Actual)Interventional2021-10-01Completed
Targeting the Knowledge Gap for Sex-specific Hormonal Influences on Inflammatory Bowel Disease Symptoms and Management [NCT05610527]40 participants (Anticipated)Interventional2024-03-01Not yet recruiting
Generating Evidence to Improve Same-day Etonogestrel (ENG) Implant Insertion for Emergency Contraception [NCT06162611]Phase 4790 participants (Anticipated)Interventional2023-11-06Recruiting
Immediate Post-partum Initiation of Etonogestrel-releasing Implant: a Randomized Controlled Trial on Breastfeeding Impact [NCT02416687]Phase 424 participants (Actual)Interventional2014-03-31Completed
A Randomized Study to Evaluate the Predictive Impact of Using Cerazette Progestin Only Pill Before Nexplanon Insertion Regarding Bleeding Pattern [NCT01438736]Phase 490 participants (Anticipated)Interventional2011-09-30Not yet recruiting
A Multicenter, Randomized, Partially-blinded, Phase IIb Dose-finding Study on Ovarian Function, Vaginal Bleeding Pattern, and Pharmacokinetics Associated With the Use of Combined Vaginal Rings Releasing 17β-estradiol Plus Three Different Doses of Either N [NCT01709318]Phase 2666 participants (Actual)Interventional2012-12-12Completed
A Randomized Controlled Trial of Immediate Postpartum Etonogestrel Implant Versus Six-week Postpartum Etonogestrel Implant: A Pilot Study [NCT01767285]Phase 460 participants (Actual)Interventional2013-01-31Completed
Safety of the Etonogestrel-releasing Implant During the Puerperium of Healthy Women [NCT00828542]40 participants (Actual)Interventional2007-07-31Completed
Effects of the Contraceptive Implant in Women With Sickle Cell Disease [NCT05730205]Phase 422 participants (Anticipated)Interventional2023-06-08Recruiting
Rates of Contraceptive Failure When Unprotected Intercourse Has Occurred 6-14 Days Prior to Contraceptive Initiation [NCT02076217]1,030 participants (Anticipated)Observational2014-02-28Active, not recruiting
Safety and Acceptability of Vaginal Rings That Protect Women From Unintended Pregnancy [NCT01796613]Phase 2/Phase 3120 participants (Actual)Interventional2013-06-30Completed
Quantification of Immune Cells in Women Using Contraception [NCT01873170]326 participants (Actual)Observational2013-08-31Completed
The Impact of Contraception on Postpartum Weight Loss: a Prospective Study [NCT02144259]100 participants (Actual)Interventional2011-04-30Completed
Pharmacokinetic Interactions of Etonogestrel (ENG) Subdermal Implants With Long-Acting (LA) Cabotegravir (CAB-LA) and LA Rilpivirine (RPV-LA) (CARLA) in Participants of Reproductive Potential [NCT05156658]Phase 40 participants (Actual)Interventional2024-01-01Withdrawn(stopped due to Protocol's question was answered elsewhere and very low site interest in the trial)
Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and Antiretroviral Therapy (ART) [NCT01903031]Phase 284 participants (Actual)Interventional2014-12-30Completed
Labor and Delivery Implant Insertion: A Randomized Controlled Trial [NCT02866643]Phase 395 participants (Actual)Interventional2016-10-28Completed
Pilot Study of Etonogestrel Contraceptive Implant Insertion at an Alternative Subdermal Scapular Site [NCT04463693]Phase 45 participants (Actual)Interventional2020-10-14Completed
Nexplanon Use in Women Primarily Choosing a Combined Oral Contraceptive: a Multicenter Trial [NCT04423055]Phase 4120 participants (Anticipated)Interventional2020-08-13Recruiting
Etonogestrel-releasing Subdermal Implant for Adolescents in the Postpartum Period: a Randomized Controlled Trial [NCT01666912]Phase 496 participants (Actual)Interventional2012-08-31Completed
A Prospective Cohort Study Evaluating the Impact of Three Progestin-based Hormonal Contraceptive (HC) Methods on Immunologic Changes in the Female Genital Tract (FGT) and Systemically [NCT03660046]225 participants (Anticipated)Observational2018-12-07Recruiting
Contraceptive Vaginal Ring Releasing Etonogestrel and Ethinylestradiol (NuvaRing): Cycle Control, Acceptability and Tolerability Study in Indian Women [NCT01490190]Phase 4252 participants (Actual)Interventional2011-12-26Completed
Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk [NCT02357368]Phase 459 participants (Actual)Interventional2015-02-28Completed
Can a Three Months Treatment With Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year? [NCT05174195]67 participants (Actual)Interventional2016-08-15Terminated(stopped due to difficult recruitment)
The UMPALA Study: A Clinical Study to Assess the Impact of Contraceptives on the Cervico-Vaginal Mucosa [NCT04814927]Phase 4112 participants (Actual)Interventional2021-03-01Completed
Randomized Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Pelvic Pain Control in Women With Endometriosis [NCT02480647]Phase 4100 participants (Actual)Interventional2016-05-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00042289 (26) [back to overview]Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs
NCT00042289 (26) [back to overview]Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
NCT00042289 (26) [back to overview]Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms
NCT00042289 (26) [back to overview]Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]Plasma Concentration for Contraceptives
NCT00612508 (2) [back to overview]Adverse Events
NCT00612508 (2) [back to overview]Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.
NCT00620035 (7) [back to overview]Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects
NCT00620035 (7) [back to overview]Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety
NCT00620035 (7) [back to overview]Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction
NCT00620035 (7) [back to overview]Implant Insertion Time (Seconds)
NCT00620035 (7) [back to overview]Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality
NCT00620035 (7) [back to overview]Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time
NCT00620035 (7) [back to overview]Implant Removal Time (Seconds)
NCT00620464 (2) [back to overview]Bioequivalence of Implanon® and Radiopaque Implanon
NCT00620464 (2) [back to overview]Bioequivalence of Implanon® and Radiopaque Implanon.
NCT00828542 (1) [back to overview]Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks
NCT00847587 (2) [back to overview]Crematocrit of Human Milk
NCT00847587 (2) [back to overview]Time to Lactogenesis Stage II
NCT01299116 (2) [back to overview]Contraceptive Method Discontinuation
NCT01299116 (2) [back to overview]Unintended Pregnancy
NCT01490190 (18) [back to overview]Number of Participants Who Plan to Continue Using Vaginal Ring
NCT01490190 (18) [back to overview]Number of Participants Who Would Recommend Vaginal Ring to Others
NCT01490190 (18) [back to overview]Number of Participants With Intermenstrual Bleeding/Spotting
NCT01490190 (18) [back to overview]Number of Participants With Regular Menstrual Cycles
NCT01490190 (18) [back to overview]Number of Pregnancies Due to Contraceptive Method Failure During the Study
NCT01490190 (18) [back to overview]Participants' Assessment of Ease of Insertion of Vaginal Ring
NCT01490190 (18) [back to overview]Participants' Assessment of Ease of Removal of Vaginal Ring
NCT01490190 (18) [back to overview]Number of Participants Who Reported a Serious Adverse Event During the Study
NCT01490190 (18) [back to overview]Frequency of Partner Feeling Vaginal Ring During Intercourse
NCT01490190 (18) [back to overview]Number of Participants Who Reported at Least One Adverse Event During the Study
NCT01490190 (18) [back to overview]Number of Spotting Days Per Cycle
NCT01490190 (18) [back to overview]Average Number of Bleeding Days Per Cycle
NCT01490190 (18) [back to overview]Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring
NCT01490190 (18) [back to overview]Frequency of Partner Objecting to Vaginal Ring Use
NCT01490190 (18) [back to overview]Number of Bleeding Days Per Cycle
NCT01490190 (18) [back to overview]Participants' Assessment of Feeling Vaginal Ring at Any Time
NCT01490190 (18) [back to overview]Participants' Assessment of Feeling Vaginal Ring During Intercourse
NCT01490190 (18) [back to overview]Participants' Overall Satisfaction With Vaginal Ring
NCT01666912 (3) [back to overview]Satisfaction
NCT01666912 (3) [back to overview]Rapid Repeat Pregnancy
NCT01666912 (3) [back to overview]Continuation at 1 Year
NCT01670656 (4) [back to overview]Change From Baseline in Total Mean Impact Score Through Cycle 2
NCT01670656 (4) [back to overview]Change From Baseline in Number of Ibuprofen Tablets Taken Through Cycle 2
NCT01670656 (4) [back to overview]Change From Baseline in Number of Days of Ibuprofen Intake Through Cycle 2
NCT01670656 (4) [back to overview]Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2
NCT01709318 (12) [back to overview]Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
NCT01709318 (12) [back to overview]Percentage of Participants Who Experienced At Least One Adverse Event
NCT01709318 (12) [back to overview]Percentage of Participants Who Experienced At Least One Drug-Related Adverse Event
NCT01709318 (12) [back to overview]Percentage of Participants Who Experienced At Least One Serious Adverse Event
NCT01709318 (12) [back to overview]Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2
NCT01709318 (12) [back to overview]Percentage of Participants With Any Drug-Related Serious Adverse Event
NCT01709318 (12) [back to overview]Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3
NCT01709318 (12) [back to overview]Percentage of Participants With Ovulation Incidence, by Cycle
NCT01709318 (12) [back to overview]Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle
NCT01709318 (12) [back to overview]Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3
NCT01709318 (12) [back to overview]Intensity of Withdrawal Bleeding During Cycle 2
NCT01709318 (12) [back to overview]Number of Participants With Venous or Arterial Thrombotic/Thromboembolic Events
NCT01767285 (6) [back to overview]Patient Satisfaction
NCT01767285 (6) [back to overview]Pregnancy Rate
NCT01767285 (6) [back to overview]Rate of Intercourse
NCT01767285 (6) [back to overview]Continuation Rate
NCT01767285 (6) [back to overview]Continuation of Breastfeeding
NCT01767285 (6) [back to overview]Continuation Rate
NCT01903031 (21) [back to overview]RTV PK Parameter Cmin Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]Ethinyl Estradiol Concentrations at Study Day 21
NCT01903031 (21) [back to overview]Etonogestrel Concentrations at Study Day 21
NCT01903031 (21) [back to overview]Percentage of Participants With Signs and Symptoms of Grade 2 or Higher Deemed Possibly, Probably or Definitely Related to Study Treatment
NCT01903031 (21) [back to overview]ATV PK Parameter AUC(0-24h) Calculated Based on Intensive Atazanavir (ATV) PK Samples Obtained From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]ATV PK Parameter CLss/F Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]ATV PK Parameter Cmax Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]ATV PK Parameter Cmin Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]ATV PK Parameter Time to Cmax (Tmax) Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]EFV PK Parameter Area Under the Concentration-Time Curve (AUC0-24hours) Calculated Based on Intensive EFV PK Samples Obtained From Individual Participants Enrolled in Arm B
NCT01903031 (21) [back to overview]EFV PK Parameter Clearance (CLss/F) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
NCT01903031 (21) [back to overview]EFV PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
NCT01903031 (21) [back to overview]EFV PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
NCT01903031 (21) [back to overview]Ethinyl Estradiol Concentrations Obtained on Study Days 7 and 14.
NCT01903031 (21) [back to overview]Etonogestrel Concentrations Obtained on Study Days 7 and 14
NCT01903031 (21) [back to overview]Proportion of Participants With Plasma HIV-1 RNA Levels <40 Copies/mL
NCT01903031 (21) [back to overview]Proportion of Participants With Progesterone Levels Greater Than 5 ng/mL.
NCT01903031 (21) [back to overview]Ritonavir (RTV) PK Parameter AUC(0-24h) Calculated Based on Intensive RTV PK Samples Obtained From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]RTV PK Parameter CLss/F Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]RTV PK Parameter Cmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
NCT01903031 (21) [back to overview]RTV PK Parameter Tmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
NCT02144259 (3) [back to overview]Contraceptive Satisfaction
NCT02144259 (3) [back to overview]Weight
NCT02144259 (3) [back to overview]Pregnancy Rate
NCT02357368 (4) [back to overview]Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood
NCT02357368 (4) [back to overview]Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood
NCT02357368 (4) [back to overview]Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood
NCT02357368 (4) [back to overview]Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood
NCT02616146 (5) [back to overview]Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index)
NCT02616146 (5) [back to overview]Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle
NCT02616146 (5) [back to overview]Number of Participants With Absence of Withdrawal Bleeding (AWB), by Cycle
NCT02616146 (5) [back to overview]Number of Participants Who Experienced an Adverse Event (AE)
NCT02616146 (5) [back to overview]Number of Participants Who Discontinued Treatment Due to an AE
NCT02668783 (2) [back to overview]Number of Participants Who Experienced an Adverse Event (AE)
NCT02668783 (2) [back to overview]Number of Participants Who Discontinued Treatment Due to an AE
NCT02852265 (5) [back to overview]Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)
NCT02852265 (5) [back to overview]Patient Interest (Measurement: Ability to Enroll)
NCT02852265 (5) [back to overview]Number of Participants Evaluating ENG as Acceptable: Acceptability (Measurement: Questionnaire)
NCT02852265 (5) [back to overview]COC Continuation Rate (Measurement: Participant Interview)
NCT02852265 (5) [back to overview]Bleeding Patterns (Measurement: Diaries)
NCT02866279 (4) [back to overview]Number of Participants Breastfeeding at 6 Months
NCT02866279 (4) [back to overview]Time to Lactogenesis Stage II
NCT02866279 (4) [back to overview]Vaginal Bleeding
NCT02866279 (4) [back to overview]Satisfaction With Contraceptive Implant
NCT02866643 (6) [back to overview]Number of Participants Reporting a Pregnancy Within 12 Months
NCT02866643 (6) [back to overview]Number of Participants Attending a Postpartum Care Visit by Month 3
NCT02866643 (6) [back to overview]Number of Participants Still With the Contraceptive Implant at Month 12.
NCT02866643 (6) [back to overview]Time to Lactogenesis Stage II [Questionnaire]
NCT02866643 (6) [back to overview]Number of of Participants Actively Breastfeeding
NCT02866643 (6) [back to overview]Number of Participants Satisfied or Very Satisfied With Implant Contraceptive
NCT03585504 (3) [back to overview]Number of Participants With Contraceptive Implant Continuation at Six Months Postpartum
NCT03585504 (3) [back to overview]Number of Participants Who Reported That They Were Somewhat or Very Satisfied With the Contraceptive Implant at Six Months Postpartum.
NCT03585504 (3) [back to overview]Number of Participants That Reported They Were Somewhat or Very Satisfied With Their Subjective Bleeding Experience at Six Months Postpartum.
NCT04463693 (2) [back to overview]Number of Participants With Side Effects
NCT04463693 (2) [back to overview]Pharmacokinetics in the Form of Serum Etonogestrel Concentrations

Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.

,
InterventionParticipants (Count of Participants)
3rd TrimesterPostpartum
EFV 600mg q.d.2021
MVC 150 or 300mg b.i.d.87

[back to top]

PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs

"Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose.~For the TAF 25 mg q.d., 10 mg q.d. w/COBI, and 25 mg q.d. w/COBI or RTV boosting arms, samples were all below the limit of quantification and statistical analyses were not conducted." (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

,,,,,,,,,,,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ATV/COBI 300/150 mg q.d.0.210.210.61
ATV/RTV Arm 1: 300/100mg q.d.2.00.71.2
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.0.490.710.90
DRV/COBI 800/150 mg q.d.0.330.271.43
DRV/RTV 800/100mg q.d.0.991.172.78
DTG 50mg q.d.0.730.931.28
EFV 600 mg q.d. (Outside THA)1.491.481.94
EVG/COBI 150/150mg q.d.0.02580.04870.3771
TAF 10mg q.d. w/COBI0.001950.001950.00195
TAF 25mg q.d.0.001950.001950.00195
TAF 25mg q.d. w/COBI or RTV Boosting0.001950.001950.00195
TFV 300mg q.d.0.0390.0540.061
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.0.30.50.8
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.0.440.571.26

[back to top]

PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ETR 200mg b.i.d.0.360.480.38
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)0.130.130.28
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.3.75.17.2
RAL 400mg b.i.d.0.06210.0640.0797

[back to top]

PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.2.842.524.51
DRV/RTV 600/100mg b.i.d.2.122.222.51
FPV/RTV 700/100mg b.i.d.2.121.642.87
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA0.470.52

[back to top]

Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8 and 12 hours post dosing.

Interventionmcg*hr/mL (Median)
Before contraceptive initiationAfter contraceptive initiation
LPV/RTV 400/100 b.i.d. With ENG115.97100.20

[back to top]

PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

Interventionmg/L (Median)
3rd TrimesterPostpartum
EFV 600mg q.d.1.602.05

[back to top]

PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 12 hrs after an observed dose.

Interventionng/mL (Geometric Mean)
3rd TrimesterPostpartum
MVC 150 or 300mg b.i.d.108128

[back to top]

PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

,,,
Interventionng/mL (Median)
2nd Trimester3rd TrimesterPostpartum
EVG/COBI 150/150mg q.d.1447.11432.81713.1
TAF 10mg q.d. w/COBI80.491.298.2
TAF 25mg q.d.69.796133
TAF 25mg q.d. w/COBI or RTV Boosting87.8107141

[back to top]

PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

Interventionmg*hour/L (Median)
3rd TrimesterPostpartum
EFV 600mg q.d.55.458.3

[back to top]

PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

Interventionng/mL (Median)
3rd TrimesterPostpartum
MVC 150 or 300mg b.i.d.448647

[back to top]

PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ETR 200mg b.i.d.0.701.010.63
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.8.410.714.6
RAL 400mg b.i.d.2.2501.7703.035
RPV 25mg q.d.0.1450.1340.134

[back to top]

PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

,,,,,,,,,,,,,,
Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
ATV/COBI 300/150 mg q.d.2.822.203.90
ATV/RTV Arm 1: 300/100mg q.d.NA3.64.1
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.3.114.514.52
DRV/COBI 800/150 mg q.d.4.593.677.04
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.6.226.558.96
DRV/RTV 600/100mg b.i.d.5.645.537.78
DRV/RTV 800/100mg q.d.6.775.788.11
DTG 50mg q.d.3.623.544.85
EFV 600 mg q.d. (Outside THA)3.875.134.41
FPV/RTV 700/100mg b.i.d.5.615.126.75
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)3.893.625.37
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA5.15.0
TFV 300mg q.d.0.2500.2450.298
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.1.22.54.1
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.2.733.565.43

[back to top]

PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.

Interventionmg/L (Median)
3rd TrimesterPostpartum
EFV 600mg q.d.5.445.10

[back to top]

PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
RPV 25mg q.d.1.9691.6692.387

[back to top]

PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.

Interventionmg/L (Median)
2nd Trimester3rd TrimesterPostpartum
RPV 25mg q.d.0.0630.0560.081

[back to top]

PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24 (area under the curve from 0 to 24 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.

,,,,,,,,,,,,,
Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
ATV/COBI 300/150 mg q.d.25.3318.8536.20
ATV/RTV Arm 1: 300/100mg q.d.88.241.957.9
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.30.645.748.8
DRV/COBI 800/150 mg q.d.50.0042.0595.55
DRV/RTV 800/100mg q.d.64.663.5103.9
DTG 50mg q.d.47.649.265.0
EFV 600 mg q.d. (Outside THA)47.3060.0262.70
EVG/COBI 150/150mg q.d.15.314.021.0
TAF 10mg q.d. w/COBI0.1970.2060.216
TAF 25mg q.d.0.1710.2120.271
TAF 25mg q.d. w/COBI or RTV Boosting0.1810.2570.283
TFV 300mg q.d.1.92.43.0
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.14.528.839.6
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.26.237.758.7

[back to top]

PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

,,,
Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
ETR 200mg b.i.d.4.58.35.3
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)14.916.127.1
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.7296133
RAL 400mg b.i.d.6.65.411.6

[back to top]

PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

,,,
Interventionmg*hour/L (Median)
2nd Trimester3rd TrimesterPostpartum
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.55.151.879.6
DRV/RTV 600/100mg b.i.d.45.845.961.7
FPV/RTV 700/100mg b.i.d.43.5032.1551.60
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA34.233.5

[back to top]

PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs

Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.

Interventionng*hour/mL (Geometric Mean)
2nd Trimester3rd TrimesterPostpartum
MVC 150 or 300mg b.i.d.NA27173645

[back to top]

Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs

Infant plasma concentrations were collected and measured during the first 9 days of life. (NCT00042289)
Timeframe: Blood samples were collected at 2-10, 18-28, 36-72 hours and 5-9 days after birth.

,,,
Interventionmcg/mL (Median)
2-10 hours after birth18-28 hours after birth36-72 hours after birth5-9 days after birth
DRV/COBI 800/150 mg q.d.0.351.431.871.72
DTG 50mg q.d.1.731.531.000.06
EFV 600 mg q.d. (Outside THA)1.11.00.90.4
EVG/COBI 150/150mg q.d.0.1320.0320.0050.005

[back to top]

Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.

,,,,,,,,,,,,,,,,,,,,,,
InterventionParticipants (Count of Participants)
2nd Trimester3rd TrimesterPostpartum
ATV/RTV Arm 1: 300/100mg q.d.11212
DRV/COBI 800/150 mg q.d.3414
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.71622
DRV/RTV 600/100mg b.i.d.71922
DRV/RTV 800/100mg q.d.91922
DTG 50mg q.d.92023
EFV 600 mg q.d. (Outside THA)123334
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.82927
ETR 200mg b.i.d.5137
EVG/COBI 150/150mg q.d.81018
FPV/RTV 700/100mg b.i.d.82622
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)101926
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.93027
ATV/COBI 300/150 mg q.d.125
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.NA1514
RAL 400mg b.i.d.113330
RPV 25mg q.d.142625
TAF 10mg q.d. w/COBI152322
TAF 25mg q.d.132324
TAF 25mg q.d. w/COBI or RTV Boosting102418
TFV 300mg q.d.22727
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.11112
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.72332

[back to top]

Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8, 12, and 24 hours post dosing.

,
Interventionmcg*hr/mL (Median)
Before contraceptive initiationAfter contraceptive initiation
ATV/RTV/TFV 300/100/300mg q.d. With ENG53.9655.25
EFV 600mg q.d. With ENG53.6456.65

[back to top]

Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs

Infant plasma concentrations were collected and measured during the first 9 days of life. Half-life is defined as 0.693/k, where k, the elimination rate constant, is the slope of the decline in concentrations. (NCT00042289)
Timeframe: Infant plasma samples at 2-10, 18-28, 36-72 hours and 5-9 days after birth.

Interventionhour (Median)
DTG 50mg q.d.32.8
EVG/COBI 150/150mg q.d.7.6
DRV/COBI 800/150 mg q.d.NA
EFV 600 mg q.d. (Outside THA)65.6

[back to top]

PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs

Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio. (NCT00042289)
Timeframe: Measured at time of delivery with single cord blood and single maternal plasma sample.

Interventionunitless (Median)
DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d.0.15
DTG 50mg q.d.1.25
EVG/COBI 150/150mg q.d.0.91
DRV/COBI 800/150 mg q.d.0.07
ATV/COBI 300/150 mg q.d.0.07
TFV 300mg q.d.0.88

[back to top]

PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs

Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio. For arms with zero overall participants analyzed, samples were below the limit of quantification and ratios could not be calculated. (NCT00042289)
Timeframe: Measured at time of delivery with single cord blood and single maternal plasma sample.

Interventionunitless (Median)
TAF 10mg q.d. w/COBI0.97
EFV 600 mg q.d. (Outside THA)0.67
EFV 600mg q.d.0.49
LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d.0.2
RAL 400mg b.i.d.1.5
ETR 200mg b.i.d.0.52
MVC 150 or 300mg b.i.d.0.33
ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d.0.14
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d.0.16
NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d.0.19
IDV/RTV Arm 2: 400/100mg q.d. (Only THA)0.12
RPV 25mg q.d.0.55
ATV/RTV 300/100mg q.d. or TFV/ATV/RTV 300/300/100mg q.d.0.18
DRV/RTV 800/100mg q.d. or DRV/RTV 600/100mg b.i.d.0.18

[back to top]

Plasma Concentration for Contraceptives

Serum concentrations of the contraceptives. Note that no historical controls were provided by team pharmacologists and thus no comparisons were done for contraceptive concentrations in women using hormonal contraceptives and selected ARV drugs as compared to historical controls not using those ARV drugs. (NCT00042289)
Timeframe: Measured at 6-7 weeks after contraceptive initiation postpartum

Interventionpg/mL (Median)
ATV/RTV/TFV 300/100/300mg q.d. With ENG604
LPV/RTV 400/100 b.i.d. With ENG428
EFV 600mg q.d. With ENG125

[back to top]

Adverse Events

Self-reported treatment-related and serious adverse events (NCT00612508)
Timeframe: over 168 days

Interventionparticipants (Number)
Oral Contraceptive1
Intravaginal Ring Contraceptive0

[back to top]

Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.

Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days (NCT00612508)
Timeframe: baseline, 84 days, 168 days

,
Interventionmm (Mean)
mean difference at 84 daysmean difference at 168 days
Desogen0.01-0.02
NuvaRing-0.005.007

[back to top]

Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects

In order to evaluate efficacy and ease of use of the Next Generation Applicator (NGA), the investigator/applicator user (AU) completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Design/technical aspects' consisted of five questions: fit of the applicator in the hand, size, weight, handling, and color of the applicator were assessed. The percentage of AUs who were very satisfied and satisfied was presented. (NCT00620035)
Timeframe: Day 1

InterventionPercentage of Applicator Users (Number)
Radiopaque Etonogestrel Implant99.1

[back to top]

Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety

In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Safety' consisted of three questions: removal of the protection cap from applicator, full retraction of the needle into the applicator after insertion, difference in colors of the obturator & the implant. The percentage of AUs who were very satisfied and satisfied was presented. (NCT00620035)
Timeframe: Day 1

InterventionPercentage of Applicator Users (Number)
Radiopaque Etonogestrel Implant98.6

[back to top]

Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction

In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Applicator Satisfaction' consisted of one question in order to assess the applicator. The percentage of AUs who were very satisfied and satisfied was presented. (NCT00620035)
Timeframe: Day 1

InterventionPercentage of Applicator Users (Number)
Radiopaque Etonogestrel Implant100

[back to top]

Implant Insertion Time (Seconds)

The implant insertion time was the time expressed in seconds, from removal of the protection cap from the applicator until retraction of the needle from the arm after insertion. Data was presented for overall investigators including experienced and non-experienced. (NCT00620035)
Timeframe: Day 1

InterventionSeconds (Mean)
Radiopaque Etonogestrel Implant27.9

[back to top]

Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality

In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Functionality' consisted of six questions assessing functionality of the needle. The percentage of AUs who were very satisfied and satisfied was presented. (NCT00620035)
Timeframe: Day 1

InterventionPercentage of Applicator Users (Number)
Radiopaque Etonogestrel Implant94.9

[back to top]

Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time

In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Used Time' consisted of one question: insertion time was assessed. The percentage of AUs who were very satisfied and satisfied was presented. (NCT00620035)
Timeframe: Day 1

InterventionPercentage of Applicator Users (Number)
Radiopaque Etonogestrel Implant100

[back to top]

Implant Removal Time (Seconds)

The implant removal time was the time expressed in seconds, from making the removal incision until placing the butterfly closure. Data was presented for overall investigators including experienced and non-experienced. (NCT00620035)
Timeframe: Day 1

InterventionSeconds (Mean)
Radiopaque Etonogestrel Implant119.3

[back to top]

Bioequivalence of Implanon® and Radiopaque Implanon

"Bioequivalence testing was performed based on serum etonogestrel Cmax. Bioequivalence was to be concluded when the 90% confidence limits of Cmax were fully contained within the acceptance range of 0.80-1.25.~Cmax (pg/mL): Peak concentration." (NCT00620464)
Timeframe: 3 years

Interventionpg/mL (Mean)
Radiopaque Implanon (ro Imp)1200
Implanon (Imp)1145

[back to top]

Bioequivalence of Implanon® and Radiopaque Implanon.

"Bioequivalence testing was performed based on serum etonogestrel AUC0-6months, AUC0-24months, and AUC0-36months. Bioequivalence was to be concluded when the 90% confidence limits of AUC0-6months, AUC0-24months, and AUC0-36months were fully contained within the acceptance range of 0.80-1.25.~AUC0-6months (Area under the curve from zero to six months).~AUC0-24months (Area under the curve from zero to 24 months).~AUC0-36months (Area under the curve from zero to 36 months)." (NCT00620464)
Timeframe: 3 years

,
Interventionpg•month/mL (Mean)
AUC (0-6 months) (n=46 ro imp; n=46 imp)AUC (0-24 months) (n=37 ro imp; n=32 imp)AUC (0-36 months) (n=32 ro imp; n=30 imp)
Implanon (Imp)229061317819
Radiopaque Implanon (ro Imp)229659547667

[back to top]

Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks

"Activated protein C (APC) resistance is the most important marker of coagulation system in women using hormonal contraceptive methods.~APC resistance was determined by testing the effect of APC on the endogenous thrombin potential (ETP) using the Calibrated Automated Thrombogram® (CAT) assay. The sensitivity ratio or APC (APCsr) of each plasma sample was determined in the presence or absence of approximately 4 nM APC (Enzyme Research Laboratories, Swansea, United Kingdom). The APC concentration was adjusted to maintain the residual thrombin generation activity in normal pooled plasma at approximately 10%. Normal pooled plasma was run in parallel on each plate.~The normalized ratio (nAPCsr) was determined by dividing the APCsr of an individual sample by the APCsr of the pooled plasma.~Thus, nAPCsr >1.0 indicated APC resistance." (NCT00828542)
Timeframe: 12 weeks

Interventionratio (Mean)
Etonogestrel Implant5.9
Depot Medroxyprogesterone5.5

[back to top]

Crematocrit of Human Milk

Determination of creamatocrit is a simple method for estimating the fat & energy content of human milk based on the centrifugation of milk in a hematocrit centrifuge. The method for creamatocrit measurement was as described by Lucas et al (LucasA, GibbsJA, LysterRL, BaumJD. Creamatocrit: simple clinical technique for estimating fat concentration and energy value of human milk. BritMedJnl1978;1:1018-20)using a standard hematocrit centrifuge, standard hematocrit glass capillary tube, & vernier calipers. Measurements were performed in duplicate and the mean for each measurement used for analysis. (NCT00847587)
Timeframe: 6 weeks postpartum

InterventionPercent creamatocrit (Mean)
Early Postpartum Insertion7.5
Standard Postpartum Insertion6.8

[back to top]

Time to Lactogenesis Stage II

"The primary outcome, time to lactogenesis stage II in hours, was documented by maternal perception as previously described and validated in the literature. Subjects were asked, Has your milk come in? Some women experience this as a prickly feeling or tingling in the breast, dripping from the other nipple when nursing, milk running from the baby's mouth, or gulping by the baby. If the response was positive, subjects were then asked, When did your milk come in? and the response recorded to the nearest hour." (NCT00847587)
Timeframe: 5 days postpartum

Interventionhours (Mean)
Early Postpartum Insertion64.3
Standard Postpartum Insertion65.2

[back to top]

Contraceptive Method Discontinuation

(NCT01299116)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
SARC - Preference300
LARC - Randomized62
SARC - Randomized142

[back to top]

Unintended Pregnancy

Intent-to-treat principles applied. (NCT01299116)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
SARC - Preference47
LARC - Randomized6
SARC - Randomized13

[back to top]

Number of Participants Who Plan to Continue Using Vaginal Ring

Participants were asked at follow-up visits after every cycle whether they planned to continue using NuvaRing, and their answers were recorded. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionParticipants (Number)
First cycle (N = 252): YesFirst cycle (N = 252): NoFirst cycle (N = 252): Missing dataSecond cycle (N = 213): YesSecond cycle (N = 213): NoSecond cycle (N = 213): Missing dataThird cycle (N = 207): YesThird cycle (N = 207): NoThird cycle (N = 207): Missing data
NuvaRing21692720553159471

[back to top]

Number of Participants Who Would Recommend Vaginal Ring to Others

Participants were asked at follow-up visits after every cycle whether they would recommend NuvaRing to other women, and their answers were reported. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionParticipants (Number)
First cycle (N = 252): YesFirst cycle (N = 252): NoFirst cycle (N = 252): Missing dataSecond cycle (N = 213): YesSecond cycle (N = 213): NoSecond cycle (N = 213): Missing dataThird cycle (N = 207): YesThird cycle (N = 207): NoThird cycle (N = 207): Missing data
NuvaRing2081628197133193131

[back to top]

Number of Participants With Intermenstrual Bleeding/Spotting

Number of participants who experienced vaginal bleeding, which includes BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. Vaginal bleeding that required >=2 pads per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad per day was classified as SPOTTING. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionParticipants (Number)
First cycle: Total bleeding/spottingFirst cycle: BleedingFirst cycle: SpottingSecond cycle: Total bleeding/spottingSecond cycle: BleedingSecond cycle: SpottingThird cycle: Total bleeding/spottingThird cycle: BleedingThird cycle: Spotting
NuvaRing514000101

[back to top]

Number of Participants With Regular Menstrual Cycles

The number of participants who experienced regular menstrual bleeding patterns throughout the period of NuvaRing use. Bleeding patterns were to be characterized by particpants as regular or irregular. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionParticipants (Number)
First cycle: RegularFirst cycle: IrregularFirst cycle: Missing dataSecond cycle: RegularSecond cycle: IrregularSecond cycle: Missing dataThird cycle: RegularThird cycle: IrregularThird cycle: Missing data
NuvaRing192931994120031

[back to top]

Number of Pregnancies Due to Contraceptive Method Failure During the Study

For participants with suspected pregnancy during in-treatment period, pregnancy was to be confirmed by hCG qualitative analysis using strip and/or other test(s) at the discretion of the treating physician. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionPregnancies (Number)
First cycle (N = 252): YesFirst cycle (N = 252): NoFirst cycle (N = 252): Missing dataSecond cycle (N = 213): YesSecond cycle (N = 213): NoSecond cycle (N = 213): Missing dataThird cycle (N = 207): YesThird cycle (N = 207): NoThird cycle (N = 207): Missing data
NuvaRing0226260210302070

[back to top]

Participants' Assessment of Ease of Insertion of Vaginal Ring

Participants were asked to classify their ability to insert the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionParticipants (Number)
First cycle: Very easyFirst cycle: EasyFirst cycle: NeutralFirst cycle: DifficultFirst cycle: Very difficultFirst cycle: FailedSecond cycle: Very easySecond cycle: EasySecond cycle: NeutralSecond cycle: DifficultSecond cycle: Very difficultSecond cycle: FailedThird cycle: Very easyThird cycle: EasyThird cycle: NeutralThird cycle: DifficultThird cycle: Very difficultThird cycle: Failed
NuvaRing59825940073105206007811312100

[back to top]

Participants' Assessment of Ease of Removal of Vaginal Ring

Participants were asked to classify their ability to remove the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionParticipants (Number)
First cycle: Very easyFirst cycle: EasyFirst cycle: NeutralFirst cycle: DifficultFirst cycle: Very difficultFirst cycle: FailedSecond cycle: Very easySecond cycle: EasySecond cycle: NeutralSecond cycle: DifficultSecond cycle: Very difficultSecond cycle: FailedThird cycle: Very easyThird cycle: EasyThird cycle: NeutralThird cycle: DifficultThird cycle: Very differentThird cycle: Failed
NuvaRing701286000811194000881132100

[back to top]

Number of Participants Who Reported a Serious Adverse Event During the Study

A serious adverse event is any adverse drug or biologic or device experience that results in death, a life-threatening adverse event, persistent or significant disability or incapacity; requires in-patient hospitalization, or prolonged hospitalization; or causes a congenital anomaly or birth defect. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionParticipants (Number)
NuvaRing0

[back to top]

Frequency of Partner Feeling Vaginal Ring During Intercourse

Participants were asked if their partners could feel the NuvaRing during intercourse and to characterize their partners' experience as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionParticipants (Number)
First cycle: NeverFirst cycle: RarelyFirst cycle: OccasionallyFirst cycle: MostlyFirst cycle: AlwaysSecond cycle: NeverSecond cycle: RarelySecond cycle: OccasionallySecond cycle: MostlySecond cycle: AlwaysThird cycle: NeverThird cycle: RarelyThird cycle: OccasionallyThird cycle: MostlyThird cycle: Always
NuvaRing88753452112652331121691031

[back to top]

Number of Participants Who Reported at Least One Adverse Event During the Study

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic, or medical device, which does not necessarily have a causal relationship with the treatment. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionParticipants (Number)
NuvaRing47

[back to top]

Number of Spotting Days Per Cycle

Intermenstrual vaginal bleeding that required <=1 pad per day was classified as SPOTTING. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionDays (Mean)
First cycle (N = 4)Second cycle (N = 0)Third cycle (N = 1)
NuvaRing5.503

[back to top]

Average Number of Bleeding Days Per Cycle

Mean duration of menstruation, per day, per cycle, during the study period. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionDays (Mean)
First cycle (N = 201)Second cycle (N = 203)Third cycle (N = 203)
NuvaRing3.83.73.6

[back to top]

Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring

Intensity of menstruation, as indicated by the median number of pads used per day by participants during each cycle of NuvaRing use. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionPads (Median)
First cycle (N = 201)Second cycle (N = 203)Third cycle (N = 203)
NuvaRing222

[back to top]

Frequency of Partner Objecting to Vaginal Ring Use

Participants were asked if their partners objected to their using the NuvaRing during intercourse and to characterize the frequency of their partners' objections as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionParticipants (Number)
First cycle: NeverFirst cycle: RarelyFirst cycle: OccasionallyFirst cycle: MostlyFirst cycle: AlwaysSecond cycle: NeverSecond cycle: RarelySecond cycle: OccasionallySecond cycle: MostlySecond cycle: AlwaysThird cycle: NeverThird cycle: RarelyThird cycle: OccasionallyThird cycle: MostlyThird cycle: Always
NuvaRing129704101435551015345330

[back to top]

Number of Bleeding Days Per Cycle

Intermenstrual vaginal bleeding that required >=2 pads per day was classified as BLEEDING. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionDays (Mean)
First cycleSecond cycleThird cycle
NuvaRing400

[back to top]

Participants' Assessment of Feeling Vaginal Ring at Any Time

Participants were asked to assess whether they could feel the NuvaRing at any time and to characterize how often as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionParticipants (Number)
First cycle: NeverFirst cycle: RarelyFirst cycle: OccasionallyFirst cycle: MostlyFirst cycle: AlwaysSecond cycle: NeverSecond cycle: RarelySecond cycle: OccasionallySecond cycle: MostlySecond cycle: AlwaysThird cycle: NeverThird cycle: RarelyThird cycle: OccasionallyThird cycle: MostlyThird cycle: Always
NuvaRing878925121078682111779530

[back to top]

Participants' Assessment of Feeling Vaginal Ring During Intercourse

Participants were asked to assess whether they could feel the NuvaRing during intercourse and to characterize how often as one the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionParticipants (Number)
First cycle: NeverFirst cycle: RarelyFirst cycle: OccasionallyFirst cycle: MostlyFirst cycle: AlwaysSecond cycle: NeverSecond cycle: RarelySecond cycle: OccasionallySecond cycle: MostlySecond cycle: AlwaysThird cycle: NeverThird cycle: RarelyThird cycle: OccasionallyThird cycle: MostlyThird cycle: Always
NuvaRing8581333210082210112569901

[back to top]

Participants' Overall Satisfaction With Vaginal Ring

Participants were asked to characterize their overall satisfaction with the NuvaRing as one of the following: very satisfied, satisfied, neutral, unsatisfied, or very unsatisfied. The number of participants who responded to each category was reported. (NCT01490190)
Timeframe: Up to 84 days (three 28-day cycles)

InterventionParticipants (Number)
First cycle (N = 252): Very satisfiedFirst cycle (N = 252): SatisfiedFirst cycle (N = 252): NeutralFirst cycle (N = 252): UnsatisfiedFirst cycle (N = 252): Very unsatisfiedFirst cycle (N = 252): Missing dataSecond cycle (N = 213): Very satisfiedSecond cycle (N = 213): SatisfiedSecond cycle(N = 213): NeutralSecond cycle (N = 213): UnsatisfiedSecond cycle (N = 213): Very unsatisfiedSecond cycle (N = 213): Missing dataThird cycle (N = 207): Very satisfiedThird cycle (N = 207): SatisfiedThird cycle (N = 207): NeutralThird cycle (N = 207): UnsatisfiedThird cycle (N = 207): Very unsatisfiedThird cycle (N = 207): Missing data
NuvaRing681192891278211215103881079111

[back to top]

Satisfaction

"To assess satisfaction with the contraceptive implant inserted in the postpartum period, using a scale of 0-10, with 0 being not satisfied at all to 10 being extremely satisfied." (NCT01666912)
Timeframe: 12 months

Interventionunits on a scale (Mean)
6 Week Postpartum Contraceptive Implant8.68
Immediate Postpartum Contraceptive Implant8.29

[back to top]

Rapid Repeat Pregnancy

To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum. (NCT01666912)
Timeframe: 12 months

Interventionparticipants (Number)
6 Week Postpartum Contraceptive Implant2
Immediate Postpartum Contraceptive Implant5

[back to top]

Continuation at 1 Year

The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum. (NCT01666912)
Timeframe: 12-14 months

Interventionparticipants (Number)
6 Week Postpartum Contraceptive Implant21
Immediate Postpartum Contraceptive Implant30

[back to top]

Change From Baseline in Total Mean Impact Score Through Cycle 2

"Total Mean Impact Score is the mean of the sum of the daily responses to questions 6, 8, 9, and 10 in the Dysmenorrhea Daily e-Dairy, as recorded within the menstrual cramping pain analysis window. These questions assessed how much interference there was from pelvic cramping pain on work/school activities (Q6), physical activities (Q8), social/leisure activities (Q9) and sleep (Q10). Each question was rated on a 5-point (0-4) scale, with 0 being not at all, 1 slightly, 2 moderately, 3 quite a bit and 4 extremely. The total mean impact score could thus range from 0 (lowest possible impact) to 16 (highest possible impact)." (NCT01670656)
Timeframe: Baseline and Day 29 to 56 (Cycle 2)

InterventionUnits on a scale (Least Squares Mean)
NOMAC-E2 700/300 mcg-4.8
NOMAC-E2 900/300 mcg-5.0
ENG-E2 100/300 mcg-4.7
ENG-E2 125/300 mcg-4.3
Placebo-3.1

[back to top]

Change From Baseline in Number of Ibuprofen Tablets Taken Through Cycle 2

Participants were provided with ibuprofen 400 mg tablets at the screening visit to be taken throughout the study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose was 3200 mg (8 tablets). Participants were instructed to take the provided ibuprofen, and no other medications, for the relief of menstrual cramping pain, and to record their ibuprofen usage in their e-Diaries. (NCT01670656)
Timeframe: Baseline and Day 29 to 56 (Cycle 2)

InterventionIbuprofen tablets (Least Squares Mean)
NOMAC-E2 700/300 mcg-6.4
NOMAC-E2 900/300 mcg-6.3
ENG-E2 100/300 mcg-7.1
ENG-E2 125/300 mcg-6.0
Placebo-4.8

[back to top]

Change From Baseline in Number of Days of Ibuprofen Intake Through Cycle 2

Participants were provided with ibuprofen 400 mg tablets at the screening visit to be taken throughout the study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose was 3200 mg (8 tablets). Participants were instructed to take the provided ibuprofen, and no other medications, for the relief of menstrual cramping pain, and to record their ibuprofen usage in their e-Diaries. (NCT01670656)
Timeframe: Baseline and Day 29 to 56 (Cycle 2)

InterventionDays of ibuprofen intake (Least Squares Mean)
NOMAC-E2 700/300 mcg-1.3
NOMAC-E2 900/300 mcg-1.7
ENG-E2 100/300 mcg-1.7
ENG-E2 125/300 mcg-1.4
Placebo-1.1

[back to top]

Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2

"The Mean Menstrual Cramping Pain score was calculated as the average of the three highest daily menstrual cramping scores (item #3 of the Menstrual Distress Questionnaire: Cramps) in the baseline cycle and treatment Cycle 2, respectively. The daily menstrual cramping pain score was based on five pain categories: none (0); mild (1); moderate (2); strong (3); and severe (4). In case of absence of withdrawal bleeding, or onset of menstruation, the mean of the three highest menstrual cramping pain scores recorded within Days 21-28 was used for analysis. The Mean Menstrual Cramping Pain Score in the baseline or subsequent cycles could range from 0 (none) to 4 (severe)." (NCT01670656)
Timeframe: Baseline and Day 29 to 56 (Cycle 2)

InterventionUnits on a scale (Least Squares Mean)
NOMAC-E2 700/300 mcg-1.7
NOMAC-E2 900/300 mcg-1.7
ENG-E2 100/300 mcg-1.9
ENG-E2 125/300 mcg-1.7
Placebo-1.2

[back to top]

Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event

An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01709318)
Timeframe: Up to ~92 days

InterventionPercentage of Participants (Number)
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day3.8
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day4.7
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day2.6
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day2.6
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day0
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day1.2
NuvaRing®1.1

[back to top]

Percentage of Participants Who Experienced At Least One Adverse Event

An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01709318)
Timeframe: Up to ~92 days

InterventionPercentage of Participants (Number)
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day43.0
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day40.0
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day43.6
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day37.7
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day39.0
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day46.5
NuvaRing®39.3

[back to top] [back to top]

Percentage of Participants Who Experienced At Least One Serious Adverse Event

A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment. (NCT01709318)
Timeframe: Up to ~92 days

InterventionPercentage of Participants (Number)
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day0.0
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day0.0
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day0.0
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day0.0
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day0.0
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day0.0
NuvaRing®0.0

[back to top]

Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2

Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed. (NCT01709318)
Timeframe: Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)

InterventionPercentage of Participants (Number)
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day5.5
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day1.9
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day4.4
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day7.8
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day3.7
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day1.9
NuvaRing®1.8

[back to top] [back to top]

Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3

Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day. (NCT01709318)
Timeframe: Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~28 days)

InterventionPercentage of Participants (Number)
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day14.6
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day13.3
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day17.5
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day13.6
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day16.3
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day6.4
NuvaRing®6.2

[back to top]

Percentage of Participants With Ovulation Incidence, by Cycle

Ovulation was defined as having 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days, confirmed by ultrasound evidence of ovulation (follicular rupture or preceding presence of a follicle-like structure >15 mm in size). (NCT01709318)
Timeframe: Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)

,,,,,,
InterventionPercentage of Participants (Number)
Cycle 1Cycle 2Cycle 3
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day000
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day000
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day000
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day000
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day000
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day000
NuvaRing®000

[back to top]

Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle

Maximum progesterone (Max P) was defined as the maximum progesterone value. Ovulation was defined as 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days during the 3 treatment cycles, supported by ultrasound evidence of ovulation. The Max P values greater than 16 nmol/L are presented by vaginal ring group and cycle. (NCT01709318)
Timeframe: Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)

,,,,,,
InterventionPercentage of Participants (Number)
Cycle 1 Max P > 16 nmol/LCycle 2 Max P > 16 nmol/LCycle 3 Max P > 16 nmol/L
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day000
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day000
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day000
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day000
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day000
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day000
NuvaRing®000

[back to top]

Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3

Intensity of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3 was defined as the ratio of the number of breakthrough bleeding days divided by the number of breakthrough bleeding and/or spotting days. Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day. (NCT01709318)
Timeframe: Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~ 28 days)

InterventionRatio (Mean)
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day0.42
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day0.80
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day0.68
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day0.73
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day0.67
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day0.33
NuvaRing®0.67

[back to top]

Intensity of Withdrawal Bleeding During Cycle 2

Intensity of withdrawal bleeding during Cycle 2 was defined as the ratio of the number of withdrawal bleeding days divided by the number of withdrawal bleeding and/or spotting days. Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed. (NCT01709318)
Timeframe: Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)

InterventionRatio (Mean)
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day0.87
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day0.92
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day0.86
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day0.90
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day0.92
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day0.93
NuvaRing®0.95

[back to top]

Number of Participants With Venous or Arterial Thrombotic/Thromboembolic Events

Venous or arterial thrombotic/thrombo-embolic events, (VTEs or ATEs) (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident) were assessed. (NCT01709318)
Timeframe: From Cycle 1 Day 1 up to 8 days after Day 28 of Cycle 3 (Up to ~92 days)

InterventionParticipants (Count of Participants)
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day0.0
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day0.0
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day0.0
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day0.0
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day0.0
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day0.0
NuvaRing®0.0

[back to top]

Patient Satisfaction

To identify differences in satisfaction with birth control method between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement. (NCT01767285)
Timeframe: 12 months

Interventionparticipants (Number)
Immediate Postpartum Etonogestrel Implant15
Delayed Postpartum Etonogestrel Implant13

[back to top]

Pregnancy Rate

To identify differences pregnancy rates between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement. (NCT01767285)
Timeframe: 12 months

Interventionparticipants (Number)
Immediate Postpartum Etonogestrel Implant0
Delayed Postpartum Etonogestrel Implant1

[back to top]

Rate of Intercourse

To identify differences in the rates of intercourse prior to the 6-week postpartum visit. (NCT01767285)
Timeframe: 6 weeks

Interventionparticipants (Number)
Immediate Postpartum Etonogestrel Implant8
Delayed Postpartum Etonogestrel Implant14

[back to top]

Continuation Rate

To identify a difference in continuation rates of Implanon® at one year between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit. (NCT01767285)
Timeframe: 6 months

Interventionparticipants (Number)
Immediate Postpartum Etonogestrel Implant27
Delayed Postpartum Etonogestrel Implant21

[back to top]

Continuation of Breastfeeding

To identify differences in continuation of breast-feeding at 6 months between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement. (NCT01767285)
Timeframe: 6 months

Interventionparticipants (Number)
Immediate Postpartum Etonogestrel Implant6
Delayed Postpartum Etonogestrel Implant5

[back to top]

Continuation Rate

To identify a difference in continuation rates of Implanon® between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit. (NCT01767285)
Timeframe: 1 year

Interventionparticipants (Number)
Immediate Postpartum Etonogestrel Implant20
Delayed Postpartum Etonogestrel Implant18

[back to top]

RTV PK Parameter Cmin Determined Based on RTV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter Cmin of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionng/mL (Median)
Cmin day 0Cmin day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs70.051.9

[back to top]

Ethinyl Estradiol Concentrations at Study Day 21

This evaluates the effect of EFV and ATV/r on ethinyl estradiol by measuring ethinyl estradiol concentrations on all three study arms 21 days after NuvaRing administration. The PK blood sample for measurement of ethinyl estradiol on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for ethinyl estradiol was 5 pg/mL ; values < 5 were assigned a value of half the lower limit (ie, 2.5 pg/mL). (NCT01903031)
Timeframe: Day 21

Interventionpg/mL (Median)
NuvaRing and no ART21.30
NuvaRing With EFV Plus ≥2 NRTIs11.40
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs16.05

[back to top]

Etonogestrel Concentrations at Study Day 21

This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 21 days after NuvaRing administration. The pharmacokinetic (PK) blood sample for measurement of etonogestrel on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values < 250 were assigned a value of half the lower limit (ie, 125 pg/mL). (NCT01903031)
Timeframe: Day 21

Interventionpg/mL (Median)
NuvaRing and no ART1860.00
NuvaRing With EFV Plus ≥2 NRTIs429.00
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs3290.00

[back to top] [back to top]

ATV PK Parameter AUC(0-24h) Calculated Based on Intensive Atazanavir (ATV) PK Samples Obtained From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of ATV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionh*ng/mL (Median)
AUC0-24h day 0AUC0-24h day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs44313.736764.7

[back to top]

ATV PK Parameter CLss/F Determined Based on ATV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the ATV PK parameter CLss/F obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/f defines apparent oral clearance. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

InterventionL/h (Median)
CLss/F day 0CLss/F day 21
NuvaRing With ATV/r Plus TDF ≥1 NRTIs6.88.2

[back to top]

ATV PK Parameter Cmax Determined Based on ATV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the ATV PK parameter Cmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionng/mL (Median)
Cmax day 0Cmax day 21
NuvaRing With ATV/r Plus TDF ≥1 NRTIs4291.03583.0

[back to top]

ATV PK Parameter Cmin Determined Based on ATV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the ATV PK parameter Cmin obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionng/mL (Median)
Cmin day 0Cmin day 21
NuvaRing With ATV/r Plus TDF ≥1 NRTIs796.7599.4

[back to top]

ATV PK Parameter Time to Cmax (Tmax) Determined Based on ATV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the ATV PK parameter Tmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Tmax defines time to maximum concentration since dose is initiated. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionhour (Median)
Tmax day 0Tmax day 21
NuvaRing With ATV/r Plus TDF ≥1 NRTIs2.93.0

[back to top]

EFV PK Parameter Area Under the Concentration-Time Curve (AUC0-24hours) Calculated Based on Intensive EFV PK Samples Obtained From Individual Participants Enrolled in Arm B

This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of EFV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionh*ng/mL (Median)
AUC0-24h day 0AUC0-24h day 21
NuvaRing With EFV Plus ≥2 NRTIs68949.157795.9

[back to top]

EFV PK Parameter Clearance (CLss/F) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B

This evaluates the effect of NuvaRing on the EFV PK parameter CLss/F obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/F defines apparent oral clearance (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

InterventionL/h (Median)
CLss/F day 0CLss/F day 21
NuvaRing With EFV Plus ≥2 NRTIs8.710.4

[back to top]

EFV PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B

This evaluates the effect of NuvaRing on the EFV PK parameter Cmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionng/mL (Median)
Cmax day 0Cmax day 21
NuvaRing With EFV Plus ≥2 NRTIs4541.03786.0

[back to top]

EFV PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B

This evaluates the effect of NuvaRing on the EFV PK parameter Cmin obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).

Interventionng/mL (Median)
Cmin day 0Cmin day 21
NuvaRing With EFV Plus ≥2 NRTIs2121.51766.0

[back to top]

Ethinyl Estradiol Concentrations Obtained on Study Days 7 and 14.

This evaluates the effect of EFV and ATV/r on ethinyl estradiol by measuring ethinyl estradiol concentrations on all three study arms 7 and 14 days after NuvaRing administration. The assay lower limit of quantification for ethinyl estradiol was 5 pg/mL; values < 5 were assigned a value of half the lower limit (ie, 2.5 pg/mL). (NCT01903031)
Timeframe: Study days 7 and 14

,,
Interventionpg/mL (Median)
Concentration at Day 7Concentration at Day 14
NuvaRing and no ART18.0519.70
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs15.7016.55
NuvaRing With EFV Plus ≥2 NRTIs9.9810.50

[back to top]

Etonogestrel Concentrations Obtained on Study Days 7 and 14

This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 7 and 14 days after NuvaRing administration. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values < 250 were assigned a value of half the lower limit (ie, 125 pg/mL). (NCT01903031)
Timeframe: Study days 7 and 14

,,
Interventionpg/mL (Median)
Concentration at Day 7Concentration at Day 14
NuvaRing and no ART1970.002070.00
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs3250.003530.00
NuvaRing With EFV Plus ≥2 NRTIs427.00437.00

[back to top]

Proportion of Participants With Plasma HIV-1 RNA Levels <40 Copies/mL

This evaluates the short-term impact of Nuvaring on virologic suppression in participants who have been administered Nuvaring alone or together with EFV or ATV/r by measuring proportion of participants with plasma HIV-1 RNA levels <40 copies/mL at study day 0 (before vaginal ring placement) and study day 21 (three weeks after vaginal ring placement). An FDA-approved HIV-1 RNA assay was required. (NCT01903031)
Timeframe: Study day 0 and study day 21

,,
Interventionproportion of participants (Number)
Proportion with HIV-1 RNA <40 copies/mL at day 0Proportion with HIV-1 RNA <40 copies/mL at day 21
NuvaRing and no ART0.220.17
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs0.890.85
NuvaRing With EFV Plus ≥2 NRTIs0.930.85

[back to top]

Proportion of Participants With Progesterone Levels Greater Than 5 ng/mL.

This evaluates alterations in progesterone levels due to the potential PK interaction between NuvaRing and the ARVs EFV and ATV/r by examining progesterone levels at study days 0 (before vaginal ring placement), 7, 14, and 21 (before vaginal ring removal), and study day 28, without regard to menstrual cycle status at study entry. (NCT01903031)
Timeframe: Study days 0, 7, 14, 21 and 28

,,
Interventionproportion of participants (Number)
Proportion with progesterone >5 at day 0Proportion with progesterone >5 at day 7Proportion with progesterone >5 at day 14Proportion with progesterone >5 at day 21Proportion with progesterone >5 at day 28
NuvaRing and no ART0.080.080.000.000.00
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs0.250.080.000.000.00
NuvaRing With EFV Plus ≥2 NRTIs0.040.240.040.000.00

[back to top]

Ritonavir (RTV) PK Parameter AUC(0-24h) Calculated Based on Intensive RTV PK Samples Obtained From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionh*ng/mL (Median)
AUC0-24h day 0AUC0-24h day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs10740.07210.7

[back to top]

RTV PK Parameter CLss/F Determined Based on RTV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter CLss/F of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/F defines apparent oral clearance. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionhour (Median)
CLss/F day 0CLss/F day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs9.313.9

[back to top]

RTV PK Parameter Cmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter Cmax of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionng/mL (Median)
Cmax day 0Cmax day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs1437.01063.0

[back to top]

RTV PK Parameter Tmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C

This evaluates the effect of NuvaRing on the PK parameter Tmax of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Tmax defines time to maximum concentration since dose is initiated. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)

Interventionhour (Median)
Tmax day 0Tmax day 21
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs3.03.0

[back to top]

Contraceptive Satisfaction

"Satisfaction will be measured in response to the question, How satisfied are you with your current birth control method? This question will be asked to the participant at the 6 month follow-up visit. Answer choices that participants could choose from range from Very Good to Very Poor. Good or Very Good responses will be analyzed as having been satisfied with the method." (NCT02144259)
Timeframe: 1 year

Interventionpercentage of women satisfied w. method (Number)
DMPA Group74
Implanon Group89
Control Group75

[back to top]

Weight

Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups (NCT02144259)
Timeframe: 6 months from postpartum (baseline)

Interventionpercent weight lost (Mean)
DMPA Group3.2
Implanon Group6.8
Control Group7.0

[back to top]

Pregnancy Rate

The secondary outcome variable is pregnancy rate. Pregnancy testing will occur at 3, 6 and 12 months postpartum or at any time that a participant felt that she might be pregnant. (NCT02144259)
Timeframe: 1 year

Interventionnumber of pregnancies (Number)
DMPA Group1
Implanon Group1
Control Group4

[back to top]

Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood

CD4/CD8 ratios above 1 indicate a strong immune system while lower ratios indicate a viral infection. (NCT02357368)
Timeframe: Week 1, Week 17

,,,
InterventionCD4/CD8 (Mean)
CD4/CD8 Ratio Cervicovaginal Lavage (CVL) Week 1CD4/CD8 Ratio CVL Week 17CD4/CD8 Ratio Peripheral Blood Mononuclear Cell (PBMC) Week 1CD4/CD8 Ratio PBMC Week 17
Depot Medroxyprogesterone Acetate (DMPA)2.42.64.32.6
Etonogestrel Impant (Eng-Implant)2.62.33.13.3
Levonorgestrel Intrauterine Device (Lng-IUD)2.92.32.92.5
ParaGard® T 380A Intrauterine Copper Contraceptive3.94.94.75.4

[back to top]

Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood

The concentration levels of interleukin 1 (IL-1) family cytokines and interferon gamma-induced protein 10 (IP-10) chemokines were determined using multiplex Luminex® assays combined with a customized multi-analytical panel of 22 human cytokines and chemokines. IL-1 and IP-10 have been found to influence recruitment of HIV target cells to the female reproductive tract and this study is examining changes in IL-1 and PI-10 to gain further understanding of these mechanisms. (NCT02357368)
Timeframe: Week 1, Week 17

,,
Interventionpg/mL (Mean)
IP-10 Cervicovaginal Lavage (CVL) Week 1IP-10 CVL Week 17IP-10 Peripheral Blood Mononuclear Cell (PBMC) Week 1IP-10 PBMC Week 17IL-1a CVL Week 1IL-1a CVL Week 17IL-1a PBMC Week 1IL-1a PBMC Week 17IL-1b CVL Week 1IL-1b CVL Week 17IL-1b PBMC Week 1IL-1b PBMC Week 17
Depot Medroxyprogesterone Acetate (DMPA)689.8445.83298.53114.4752.2550.758.547.832.921.120.020.8
Etonogestrel Impant (Eng-Implant)2551.12417.64107.33954.31640.22120.6156.2144.1583.4485.851.446.5
Levonorgestrel Intrauterine Device (Lng-IUD)1100.21241.5204.4209.6256.4184.754.665.143.937.14.24.3

[back to top]

Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood

Following exposure to HIV, initial infection occurs at the genital mucosa and may involve complex interactions between a number of HIV target immune cells. HIV often uses C-C Chemokine Receptor Type 5 (CCR5) for entrance into target immune cells, causing infection of the cell. The amount of CCR5 expressing macrophages is associated with HIV infection. Cluster of differentiation 4 (CD4) T Cells are targeted and infected by HIV and CD4 percentages are used to assess immune status. CD4 counts vary by individuals and generally decrease with HIV infection. (NCT02357368)
Timeframe: Week 1, Week 17

,,,
Interventionpercentage of HIV target immune cells (Mean)
CCR5+ CD4 T-cells Cervicovaginal Lavage (CVL) Week 1CCR5+ CD4 T-cells CVL Week 17CCR5+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1CCR5+ CD4 T-cells PBMC Week 17CD4% CVL Week 1CD4% CVL Week 17CD4% PBMC Week 1CD4% PBMC Week 17
Depot Medroxyprogesterone Acetate (DMPA)26.639.24.15.747.247.465.663.9
Etonogestrel Impant (Eng-Implant)22.832.23.94.248.747.067.467.5
Levonorgestrel Intrauterine Device (Lng-IUD)16.923.32.92.654.048.865.763.4
ParaGard® T 380A Intrauterine Copper Contraceptive22.415.38.37.563.447.573.371.1

[back to top]

Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood

T cell activation correlates with HIV infection progression and this study seeks to gain better understanding of these underlying mechanisms by assessment of HIV target cells. Changes in cluster of differentiation 38 (CD38) expression are indicators of HIV disease progression with increases seen in CD38+ when a chronic HIV infection is progressing. Human leukocyte antigen-antigen D related (HLA-DR)+ expression appears to be involved in HIV proliferation. (NCT02357368)
Timeframe: Week 1, Week 17

,,,
Interventionpercentage of T cell activation markers (Mean)
CD38+ CD4 T-cells Cervicovaginal Lavage (CVL) Week 1CD38+ CD4 T-cells CVL Week 17CD38+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1CD38+ CD4 T-cells PBMC Week 17HLA-DR+ CD4 T-cells CVL Week 1HLA-DR+ CD4 T-cells CVL Week 17HLA-DR+ CD4 T-cells PBMC Week 1HLA-DR+ CD4 T-cells PBMC Week 17CD38+ Target (CCR5+ CD4+) T cells CVL Week 1CD38+ Target (CCR5+ CD4+) T cells CVL Week 17CD38+ Target (CCR5+ CD4+) T cells PBMC Week 1CD38+ Target (CCR5+ CD4+) T cells PBMC Week 17HLA-DR+ Target (CCR5+ CD4+) T cells CVL Week 1HLA-DR+ Target (CCR5+ CD4+) T cells CVL Week 17HLA-DR+ Target (CCR5+ CD4+) T cells PBMC Week 1HLA-DR+ Target (CCR5+ CD4+) T cells PBMC Week 17
Depot Medroxyprogesterone Acetate (DMPA)36.735.917.117.725.021.24.84.462.552.522.724.130.730.024.423.2
Etonogestrel Impant (Eng-Implant)36.941.717.617.626.917.83.02.364.561.626.029.641.325.522.621.6
Levonorgestrel Intrauterine Device (Lng-IUD)32.644.017.017.215.411.43.33.666.270.828.231.728.217.628.325.5
ParaGard® T 380A Intrauterine Copper Contraceptive23.245.525.236.38.721.13.42.512.742.418.630.920.126.516.510.1

[back to top]

Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index)

The Primary Efficacy Outcome Measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days). NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. (NCT02616146)
Timeframe: Up to 1 year (13 28-day cycles)

InterventionPregnancies per 100 woman years (Number)
ENG-E2 125 μg/300 μg1.54
LNG-EE 150 μg/30 μg2.93

[back to top]

Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle

BTB-S was considered any bleeding/spotting that occurred during expected non-bleeding interval that was neither early nor continued withdrawal bleeding. BTB-S was classified as follows: Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. (NCT02616146)
Timeframe: Up to 1 year

,
InterventionParticipants (Count of Participants)
Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Cycle 7Cycle 8Cycle 9
ENG-E2 125 μg/300 μg1661127942291381
LNG-EE 150 μg/30 μg543620138720

[back to top]

Number of Participants With Absence of Withdrawal Bleeding (AWB), by Cycle

Participants were asked to keep a daily diary to record vaginal bleeding events. AWB was defined as no bleeding/spotting during the expected bleeding period. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. (NCT02616146)
Timeframe: Up to 1 year

,
InterventionParticipants (Count of Participants)
Cycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Cycle 7Cycle 8Cycle 9
ENG-E2 125 μg/300 μg7634261733000
LNG-EE 150 μg/30 μg151010601210

[back to top]

Number of Participants Who Experienced an Adverse Event (AE)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. (NCT02616146)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
ENG-E2 125 μg/300 μg530
LNG-EE 150 μg/30 μg140

[back to top]

Number of Participants Who Discontinued Treatment Due to an AE

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. (NCT02616146)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
ENG-E2 125 μg/300 μg61
LNG-EE 150 μg/30 μg23

[back to top]

Number of Participants Who Experienced an Adverse Event (AE)

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who experienced an AE is presented. (NCT02668783)
Timeframe: Up to approximately 158 days

InterventionParticipants (Number)
ENG-E2 125 μg/300 μg1
Placebo2

[back to top]

Number of Participants Who Discontinued Treatment Due to an AE

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinued study treatment due to an AE is presented. (NCT02668783)
Timeframe: Up to approximately 128 days

InterventionParticipants (Number)
ENG-E2 125 μg/300 μg0
Placebo0

[back to top]

Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)

Evaluate the tolerability (side effects) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception (NCT02852265)
Timeframe: 6 months

,
Interventionparticipants (Number)
headachenauseamastalgiamood complaintsworsening acneworsening dysmenorrheaweight gain
Continuing COC Users0000011
New Start COC Users2111222

[back to top]

Patient Interest (Measurement: Ability to Enroll)

"Demonstrate that women desiring a COC are willing to use ENG implant concomitantly as a continuous back-up contraceptive" (NCT02852265)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
COC Users10
COC New Starts10

[back to top]

Number of Participants Evaluating ENG as Acceptable: Acceptability (Measurement: Questionnaire)

Evaluate the acceptability (continuation of the implant throughout the study) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception (NCT02852265)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
New Start COC Users9
Continuing COC Users8

[back to top]

COC Continuation Rate (Measurement: Participant Interview)

Continuation rate of COC over 6 months of evaluation regardless on whether or not the implant was still present at 6 months (NCT02852265)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
COC Users6
New Starts5

[back to top]

Bleeding Patterns (Measurement: Diaries)

Bleeding patterns while using a COC concomitantly with ENG implant (NCT02852265)
Timeframe: 6 months

,
InterventionParticipants (Count of Participants)
prolonged 1st 90 daysfrequent 1st 90 daysirregular 1st 90 daysinfrequent 1st 90 daysamenorrhea 1st 90 daysregular 1st 90 daysprolonged 2nd 90 daysfrequent 2nd 90 daysirregular 2nd 90 daysinfrequent 2nd 90 daysamenorrhea 2nd 90 daysregular 2nd 90 days
COC Users122103002511
New Starts112302122211

[back to top]

Number of Participants Breastfeeding at 6 Months

Exclusive Breastfeeding at 6 months (NCT02866279)
Timeframe: 6 months postpartum

InterventionParticipants (Count of Participants)
Postplacental6
Immediate Postpartum4
Delayed6

[back to top]

Time to Lactogenesis Stage II

Difference in time to Lactogenesis Stage II (NCT02866279)
Timeframe: 1-5 days postpartum

Interventionhours (Mean)
Postplacental66.9
Immediate Postpartum62.1
Delayed57.3

[back to top]

Vaginal Bleeding

Number of Participants that reported heavy bleeding at 6 months postpartum (NCT02866279)
Timeframe: 0-6 months postpartum

InterventionParticipants (Count of Participants)
Postplacental7
Immediate Postpartum6
Delayed4

[back to top]

Satisfaction With Contraceptive Implant

Satisfaction on a 1-10 scale (10 being highly satisfied) at 6 months postpartum (NCT02866279)
Timeframe: 0-6 months postpartum

Interventionscore on a scale (Mean)
Postplacental8.41
Immediate Postpartum8.14
Delayed8.69

[back to top]

Number of Participants Reporting a Pregnancy Within 12 Months

(NCT02866643)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Delivery Room Insertion1
Postpartum Insertion1

[back to top]

Number of Participants Attending a Postpartum Care Visit by Month 3

(NCT02866643)
Timeframe: month 3

InterventionParticipants (Count of Participants)
Delivery Room Insertion17
Postpartum Insertion24

[back to top]

Number of Participants Still With the Contraceptive Implant at Month 12.

(NCT02866643)
Timeframe: month 12

InterventionParticipants (Count of Participants)
Delivery Room Insertion14
Postpartum Insertion12

[back to top]

Time to Lactogenesis Stage II [Questionnaire]

"Lactogenesis Stage II: The initiation of copious milk secretion as documented by maternal perception.~To obtain measurement of time to lactogenesis, we will document time at which participants perceive initiation of copious milk secretion using a set of specific validated questions and subtract this by the documented time of delivery." (NCT02866643)
Timeframe: Participants will be monitored daily by the research staff, in the first seven days postpartum, or until lactogenesis reported, beginning at 24-hours following delivery, to determine time to lactogenesis stage II.

Interventionhours (Mean)
Delivery Room Insertion65
Postpartum Insertion67.5

[back to top]

Number of of Participants Actively Breastfeeding

Exclusive breastfeeding means feedling with breast milk only. Any breast feeding means feeding with breast milk, with water and/or formula. (NCT02866643)
Timeframe: 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after delivery

,
InterventionParticipants (Count of Participants)
Exclusive - week 2Exclusive - week 4Exclusive - month 3Exclusive - month 6Any - week 2Any - week 4Any - month 3Any - month 6Any - month 12
Delivery Room Insertion131097251718135
Postpartum Insertion16863272220137

[back to top]

Number of Participants Satisfied or Very Satisfied With Implant Contraceptive

Participant-rated as very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, or very dissatisfied. (NCT02866643)
Timeframe: month 12

InterventionParticipants (Count of Participants)
Delivery Room Insertion16
Postpartum Insertion10

[back to top]

Number of Participants With Contraceptive Implant Continuation at Six Months Postpartum

We compare the number of participants continuing the implant at six months in each group. (NCT03585504)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Intervention Group15
Control Group7

[back to top]

Number of Participants Who Reported That They Were Somewhat or Very Satisfied With the Contraceptive Implant at Six Months Postpartum.

"Comparison of the number of participants in each group who report that they were somewhat or very satisfied with their contraceptive method choice at six months postpartum in each group. Participants were asked, How would you rate your overall satisfaction with implanon? The response options were very satisfied, somewhat satisfied, somewhat dissatisfied, and very dissatisfied. The outcome measure was treated as a categorical variable." (NCT03585504)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Intervention Group14
Control Group6

[back to top]

Number of Participants That Reported They Were Somewhat or Very Satisfied With Their Subjective Bleeding Experience at Six Months Postpartum.

"Compare the number of participants who reported that they were somewhat or very satisfied with their subjective bleeding experience at six months postpartum in each group. Each participant was asked, Please indicate your overall level of satisfaction with your bleeding. The response options were very satisfied, somewhat satisfied, somewhat dissatisfied, and very dissatisfied. The outcome measure was treated as a categorical variable." (NCT03585504)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Intervention Group10
Control Group8

[back to top]

Number of Participants With Side Effects

Local and systematic side effects associated with etonogestrel contraceptive implant use (NCT04463693)
Timeframe: "One and two weeks for post-insertion site discomfort, over 12 months for Amenorrhea, Persistent bleeding, and Intermittent bleeding"

InterventionParticipants (Count of Participants)
One-week post insertion site discomfortTwo-week post insertion site discomfortAmenorrheaPersistent bothersome bleedingIntermittent bleeding
Etonogestrel Implant40113

[back to top]

Pharmacokinetics in the Form of Serum Etonogestrel Concentrations

Serum etonogestrel concentration curves measured over the first year of implant use (NCT04463693)
Timeframe: 1 week and 12 months

Interventionpg/mL (Mean)
One-week post insertion12 months post-insertion
Etonogestrel Implant511.7136.6

[back to top]