| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| A Multicenter, Open Label, Randomized, Two-period Crossover Study on the Insertion of MK-8342A (NuvaRing®) Placebo With and Without the Use of NuvaRing Applicator in Healthy Female Subjects [NCT02275546] | Phase 3 | 164 participants (Actual) | Interventional | 2014-12-11 | Completed |
| Combined Contraceptive Vaginal Ring or Norethisterone for Treatment of Idiopathic Menorrhagia [NCT01266759] | | 95 participants (Actual) | Interventional | 2008-07-31 | Completed |
| An Open-label, Randomized, Parallel Group Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) [NCT01044056] | Phase 4 | 24 participants (Actual) | Interventional | 2004-03-31 | Completed |
| Phase 4 Study Comparison of Two Combined Oral Contraceptive Regimens and an Intravaginal Hormonal Ring Against Placebo for Management of Bleeding Problems in Women Using Implanon, the Sub-dermal Contraceptive Implant [NCT01384331] | Phase 4 | 200 participants (Anticipated) | Interventional | 2011-07-31 | Not yet recruiting |
| AFTER: Application for the Etonogestrel/Ethinyl Estradiol Ring--potential for Emergency Contraception [NCT03120728] | Phase 4 | 36 participants (Anticipated) | Interventional | 2017-07-10 | Recruiting |
| "Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents: A Randomized Controlled Trial" [NCT00369967] | | 48 participants (Actual) | Interventional | 2007-02-28 | Terminated(stopped due to difficulty in subject recruitment) |
| Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity [NCT02432404] | Phase 4 | 120 participants (Actual) | Interventional | 2016-03-31 | Completed |
| Clinical Trial of Acceptability, Adherence and Immune/Microbiologic Effects of a Vaginal Contraceptive Ring Among HIV-negative Women in Western Kenya [NCT02529683] | | 200 participants (Actual) | Interventional | 2014-04-30 | Completed |
| The Impact of Different Administration Routes of Hormonal Contraceptives on Androgen Synthesis, Glucose Metabolism and Inflammation. A Prospective Randomized Trial. [NCT01087879] | | 45 participants (Anticipated) | Interventional | 2007-10-31 | Completed |
| The Effect of Oral vs. Non-oral Contraceptive Therapy on Bone Turnover Using 41Ca Methodology [NCT02367846] | Phase 4 | 6 participants (Actual) | Interventional | 2015-01-31 | Active, not recruiting |
| Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing® [NCT00710606] | | 40 participants (Actual) | Interventional | 2008-06-30 | Completed |
| The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health [NCT00612508] | | 14 participants (Actual) | Interventional | 2007-05-31 | Completed |
| Acceptability of the NuvaRing Among College and Graduate Students [NCT00635570] | Phase 4 | 273 participants (Actual) | Interventional | 2008-07-31 | Completed |
| Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women Protocol: WHIRL-07-2971 [NCT00565240] | | 41 participants (Actual) | Interventional | 2007-11-30 | Completed |
| Does Vaginal Delivery of Combined Hormonal Contraception Affect the Risk of Metabolic Syndrome in Overweight/Obese Women With PCOS [NCT04257500] | Phase 4 | 40 participants (Anticipated) | Interventional | 2020-06-24 | Recruiting |
| SINGLE DOSE CROSSOVER COMPARATIVE BIOAVAILABILITY STUDY OF ETHINYL ESTRADIOL/ETONOGESTREL VAGINAL RING (DELIVERING 0.015 mg/0.12 mg PER DAY) WORN FOR 21 DAYS IN HEALTHY FEMALE SUBJECTS [NCT05994599] | Phase 1 | 36 participants (Anticipated) | Interventional | 2023-07-28 | Recruiting |
| An Open-Label, Randomized, Multicenter Trial to Evaluate Continuation Rates, Side Effects and Acceptability of NuvaRing Versus OrthoEvra [NCT00269620] | Phase 4 | 500 participants (Actual) | Interventional | 2005-06-30 | Completed |
| The Frequency and Management of Breakthrough Bleeding During Extended Therapy With the Transvaginal Contraceptive Ring [NCT00475553] | | 75 participants (Actual) | Interventional | 2006-05-31 | Completed |
| Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity [NCT02445989] | Phase 4 | 120 participants (Actual) | Interventional | 2016-05-31 | Completed |
| An Open-label, Randomized, 2-Period, Crossover Study to Assess the Comparative Pharmacokinetics of LSP-5415 and NuvaRing® in Healthy Adult Females [NCT05360576] | Phase 2 | 40 participants (Actual) | Interventional | 2022-02-24 | Completed |
| A Randomized Controlled Trial of NuvaRing® Versus Combined Oral Contraceptive Pills for Pre-treatment in In-Vitro Fertilization (IVF) Cycles [NCT01298128] | | 70 participants (Actual) | Interventional | 2006-02-28 | Terminated |
| Effect of Using the Nuvaring on the Level of Satisfaction, Stress on Users and on Coordinating In Vitro Fertilization (IVF) Cycles: Randomized Public Study [NCT01638767] | Phase 4 | 7 participants (Actual) | Interventional | 2012-07-31 | Terminated(stopped due to Difficulty to recruit patient due to lack of eligible patient) |
| The Effects of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) on Vaginal Innate and Inflammatory Biomarkers [NCT01448291] | Phase 4 | 30 participants (Anticipated) | Interventional | 2011-10-31 | Recruiting |
| An Open-Label, Randomized Crossover Study to Evaluate the Acceptability and Preference for Contraceptive Options in Healthy HIV-Uninfected Female Adolescents, 16-17 Years of Age, as Proxy for HIV Prevention Methods [NCT02404038] | | 131 participants (Actual) | Interventional | 2015-07-31 | Active, not recruiting |
| The Effects of Contraceptive Pill and Hormonal Vaginal Ring on Hormonal, Inflammatory and Metabolic Parameters in Women of Reproductive Age With Polycystic Ovary Syndrome (PCOS). [NCT01588873] | Phase 4 | 42 participants (Anticipated) | Interventional | 2012-04-30 | Recruiting |
| Psychosocial and Physiological Mechanisms in the Effect of Hormonal Contraception on the Female Sexual Desire [NCT00374387] | | 150 participants (Anticipated) | Interventional | 2006-09-30 | Completed |
| Safety and Acceptability of Vaginal Rings That Protect Women From Unintended Pregnancy [NCT01796613] | Phase 2/Phase 3 | 120 participants (Actual) | Interventional | 2013-06-30 | Completed |
| Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and Antiretroviral Therapy (ART) [NCT01903031] | Phase 2 | 84 participants (Actual) | Interventional | 2014-12-30 | Completed |
| Contraceptive Vaginal Ring Releasing Etonogestrel and Ethinylestradiol (NuvaRing): Cycle Control, Acceptability and Tolerability Study in Indian Women [NCT01490190] | Phase 4 | 252 participants (Actual) | Interventional | 2011-12-26 | Completed |
| A Randomized, Open-Label, Controlled, Multi-Center Trial to Evaluate the Contraceptive Efficacy, Cycle Control, Safety and Acceptability of NuvaRing® (SCH 900702) in Chinese Women [NCT01277211] | Phase 3 | 983 participants (Actual) | Interventional | 2011-09-19 | Completed |
| Primary Mechanisms Underlying the Effects of Oral vs. Non-oral Contraceptives on the GH/IGF-1 Axis and Bone Metabolism in Young Women [NCT02367833] | Phase 4 | 60 participants (Actual) | Interventional | 2015-01-31 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
| Trial | Outcome |
|---|
| NCT00369967 (4) [back to overview] | Method Continuation at 12 Months |
| NCT00369967 (4) [back to overview] | Continuation With the Contraceptive Method |
| NCT00369967 (4) [back to overview] | Method Continuation at 6 Months |
| NCT00369967 (4) [back to overview] | Pregnancy |
| NCT00612508 (2) [back to overview] | Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. |
| NCT00612508 (2) [back to overview] | Adverse Events |
| NCT00635570 (4) [back to overview] | Adherence Rate (Rate of Perfect Method Use) |
| NCT00635570 (4) [back to overview] | Continuation Rate |
| NCT00635570 (4) [back to overview] | Continuation Rate |
| NCT00635570 (4) [back to overview] | Satisfaction Rate |
| NCT00710606 (3) [back to overview] | Mean Endometrial Proliferation |
| NCT00710606 (3) [back to overview] | Number of Participants Achieving a Maximum Follicle Diameter > 13mm During the 3 Weeks of Follow-up |
| NCT00710606 (3) [back to overview] | Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol |
| NCT01044056 (4) [back to overview] | Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group |
| NCT01044056 (4) [back to overview] | AUC 0-infinity (PK Parameter) for the ASPE Group. |
| NCT01044056 (4) [back to overview] | AUC 0-tlast (PK Parameter) for the ASPE Group. |
| NCT01044056 (4) [back to overview] | Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group |
| NCT01277211 (3) [back to overview] | Pearl Index, by Treatment Group |
| NCT01277211 (3) [back to overview] | Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle |
| NCT01277211 (3) [back to overview] | Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle |
| NCT01298128 (1) [back to overview] | Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description) |
| 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] | Number of Spotting Days Per Cycle |
| NCT01490190 (18) [back to overview] | Participants' Assessment of Ease of Insertion of Vaginal Ring |
| 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 |
| 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] | Number of Participants Who Reported at Least One Adverse Event During the Study |
| 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 Feeling Vaginal Ring During Intercourse |
| NCT01490190 (18) [back to overview] | Frequency of Partner Objecting to Vaginal Ring Use |
| NCT01490190 (18) [back to overview] | Number of Bleeding Days Per Cycle |
| 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] | RTV PK Parameter Tmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C |
| 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] | EFV PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B |
| 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 Cmin Determined Based on RTV Levels From Individual Participants Enrolled in Arm C |
| 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 Clearance (CLss/F) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B |
| 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 |
| NCT02275546 (2) [back to overview] | Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion |
| NCT02275546 (2) [back to overview] | Percentage of Participants With Successful Ring Insertion |
| NCT02367833 (1) [back to overview] | Changes in Insulin-like Growth Factor-1 (IGF-1), IGF Binding Proteins (IGFBP-1, IGFBP-3), and Acid Labile Subunit (ALS) |
Method Continuation at 12 Months
Participants reporting continuation with method at 12 months (NCT00369967)
Timeframe: 12 months
| Intervention | participants (Number) |
|---|
| Quick Start | 0 |
| Traditional Start | 2 |
Continuation With the Contraceptive Method
Participants reporting continuation with contraceptive method at 3 months (NCT00369967)
Timeframe: 3 months
| Intervention | participants (Number) |
|---|
| Quick Start | 5 |
| Traditional Start | 11 |
Method Continuation at 6 Months
Participants reporting continuation of method at 6 months (NCT00369967)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Traditional Start | 7 |
| Quick Start | 2 |
Pregnancy
Number of pregnancies reported (NCT00369967)
Timeframe: 3,6, and 12 mo
| Intervention | participants (Number) |
|---|
| Quick Start | 0 |
| Traditional Start | 0 |
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
| Intervention | mm (Mean) |
|---|
| mean difference at 84 days | mean difference at 168 days |
|---|
| Desogen | 0.01 | -0.02 |
,| NuvaRing | -0.005 | .007 |
Adverse Events
Self-reported treatment-related and serious adverse events (NCT00612508)
Timeframe: over 168 days
| Intervention | participants (Number) |
|---|
| Oral Contraceptive | 1 |
| Intravaginal Ring Contraceptive | 0 |
Adherence Rate (Rate of Perfect Method Use)
"Perfect use was defined as reporting never missing a pill or never removing the contraceptive vaginal ring for more than 2 hours during days 1-21 of all three monthly cycles" (NCT00635570)
Timeframe: For the first 3 months
| Intervention | Percentage of Participants (Number) |
|---|
| Contraceptive Vaginal Ring | 57 |
| Oral Contraceptive Pill | 45 |
Continuation Rate
Rate of intention to continue the contraceptive method at 3 months (NCT00635570)
Timeframe: at 3 months
| Intervention | Percentage of Participants (Number) |
|---|
| Continuation - Yes | Continuation - No | Missing |
|---|
| Contraceptive Vaginal Ring | 43 | 52 | 5 |
,| Oral Contraceptive Pill | 52 | 48 | 0 |
Continuation Rate
Rate of intention to continue the contraceptive method at 6 months (NCT00635570)
Timeframe: at 6 month (3 month after the end of the study period)
| Intervention | Percentage of Participants (Number) |
|---|
| Continuation - Yes | Continuation - No | Missing |
|---|
| Contraceptive Vaginal Ring | 26 | 72 | 2 |
,| Oral Contraceptive Pill | 29 | 68 | 2 |
Satisfaction Rate
(NCT00635570)
Timeframe: at 3 months
| Intervention | Percentage of Participants (Number) |
|---|
| Satisfaction - Yes | Satisfaction - No | Missing |
|---|
| Contraceptive Vaginal Ring | 68 | 23 | 9 |
,| Oral Contraceptive Pill | 71 | 25 | 4 |
Mean Endometrial Proliferation
The mean endometrial proliferation from week 1, week 2 and week3 (NCT00710606)
Timeframe: Transvaginal ultrasound measurements of endometrial proliferation will be completed over continuous ring use, an average of 3 weeks
| Intervention | millimeters (Mean) |
|---|
| Obese Subjects | 4.7 |
| Normal Weight Subjects | 3.9 |
Number of Participants Achieving a Maximum Follicle Diameter > 13mm During the 3 Weeks of Follow-up
Follicular development was minimal in both groups, with only five women achieving a maximum follicle diameter > 13mm at any time during the 3 weeks of follow-up (3 normal weight and 2 obese women). (NCT00710606)
Timeframe: continuous ring use, an average of 3 weeks
| Intervention | Participant w/follicular diameter >=13mm (Number) |
|---|
| Obese Subjects | 2 |
| Normal Weight Subjects | 3 |
Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol
Serum concentrations were obtained from thirty-seven women completed follow-up. (NCT00710606)
Timeframe: Measurements at Week 3 and Week 6 continuous ring use
| Intervention | ng/L (Geometric Mean) |
|---|
| Etonogesterel (ENG) Week 3 | Ethinyl Estradiol (EE) Week 3 | Etonogesterel (ENG) Week 6 | Ethinyl Estradiol (EE) Week 6 |
|---|
| Normal Weight | 1275 | 21.9 | 1063 | 16.2 |
,| Obese | 1240 | 14.8 | 1096 | 12.5 |
Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group
AUC 0-21 days was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment (NCT01044056)
Timeframe: 21 days
| Intervention | nh.h/mL (Mean) |
|---|
| Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill | 21.9 |
| Norelgestrominum and Ethinylestradiol Contraceptive Patch | 35.8 |
| Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring | 10.6 |
AUC 0-infinity (PK Parameter) for the ASPE Group.
AUC 0-infinity was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter. AUC 0-infinity was calculated as AUC 0-tlast extrapolated to infinity using the regression line from which t 1/2 was calculated. (NCT01044056)
Timeframe: 21 days of active treatment and the washout period thereafter
| Intervention | ng.h/mL (Mean) |
|---|
| Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill | 22.7 |
| Norelgestrominum and Ethinylestradiol Contraceptive Patch | 37.7 |
| Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring | 11.2 |
AUC 0-tlast (PK Parameter) for the ASPE Group.
AUC 0-tlast was measured using ethinylestradiol serum concentrations using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter. (NCT01044056)
Timeframe: 21 days of active treatment and washout period thereafter
| Intervention | ng.h/mL (Mean) |
|---|
| Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill | 22.5 |
| Norelgestrominum and Ethinylestradiol Contraceptive Patch | 37.5 |
| Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring | 11.1 |
Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group
Cmax was measured using ethinylstradiol serum concentration at several time points during the 21 days of active treatment and the washout thereafter. (NCT01044056)
Timeframe: 21 days of active treatment and washout period thereafter
| Intervention | pg/ml (Mean) |
|---|
| Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill | 168 |
| Norelgestrominum and Ethinylestradiol Contraceptive Patch | 105 |
| Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring | 37.1 |
Pearl Index, by Treatment Group
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). (NCT01277211)
Timeframe: Up to 1 year
| Intervention | Pregnancies per 100 woman-years (Mean) |
|---|
| ENG-EE (NuvaRing) | 1.92 |
| DRSP-EE | 3.12 |
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
"Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as breakthough bleeding.) Vaginal bleeding that required >=2 pads/tampons per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad/tampon per day was classified as SPOTTING." (NCT01277211)
Timeframe: Up to 1 year
| Intervention | Percentage of participants (Number) |
|---|
| Cycle 1 (n=598,199) | Cycle 2 (n=604,195) | Cycle 3 (n=578,196) | Cycle 4 (n=587,194) | Cycle 5 (n=592,187) | Cycle 6 (n=590,185) | Cycle 7 (n=583,186) | Cycle 8 (n=585,188) | Cycle 9 (n=576,187) | Cycle 10 (n=572,183) | Cycle 11 (n=578,177) | Cycle 12 (n=569,176) | Cycle 13 (n=544,173) |
|---|
| DRSP-EE | 21.6 | 18.5 | 14.3 | 15.5 | 8.0 | 10.8 | 11.3 | 10.6 | 8.0 | 10.4 | 7.9 | 9.7 | 11.0 |
,| ENG-EE (NuvaRing) | 18.6 | 12.3 | 8.5 | 7.5 | 6.8 | 6.9 | 7.5 | 6.3 | 6.9 | 5.9 | 4.2 | 5.3 | 6.4 |
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period. (NCT01277211)
Timeframe: Up to 1 year
| Intervention | Percentage of participants (Number) |
|---|
| Cycle 1 (n=596,199) | Cycle 2 (n=602,195) | Cycle 3 (n=577,196) | Cycle 4 (n=586,194) | Cycle 5 (n=590,187) | Cycle 6 (n=588,185) | Cycle 7 (n=581,186) | Cycle 8 (n=583,188) | Cycle 9 (n=575,187) | Cycle 10 (n=571,183) | Cycle 11 (n=576,177) | Cycle 12 (n=568,176) | Cycle 13 (n=543,173) |
|---|
| DRSP-EE | 14.6 | 9.7 | 11.7 | 7.7 | 6.4 | 9.7 | 7.5 | 6.9 | 8.6 | 6.6 | 7.3 | 10.2 | 10.4 |
,| ENG-EE (NuvaRing) | 8.6 | 4.8 | 5.2 | 4.1 | 5.4 | 5.8 | 3.4 | 5.0 | 4.3 | 3.7 | 3.0 | 4.0 | 5.9 |
Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)
abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain (NCT01298128)
Timeframe: patients were followed for the duration of an in-vitro fertilization cycle- 2 months
| Intervention | participants (Number) |
|---|
| NuvaRing | 3 |
| Combined Oral Contraceptive Pill | 4 |
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)
| Intervention | Participants (Number) |
|---|
| First cycle (N = 252): Yes | First cycle (N = 252): No | First cycle (N = 252): Missing data | Second cycle (N = 213): Yes | Second cycle (N = 213): No | Second cycle (N = 213): Missing data | Third cycle (N = 207): Yes | Third cycle (N = 207): No | Third cycle (N = 207): Missing data |
|---|
| NuvaRing | 216 | 9 | 27 | 205 | 5 | 3 | 159 | 47 | 1 |
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)
| Intervention | Participants (Number) |
|---|
| First cycle (N = 252): Yes | First cycle (N = 252): No | First cycle (N = 252): Missing data | Second cycle (N = 213): Yes | Second cycle (N = 213): No | Second cycle (N = 213): Missing data | Third cycle (N = 207): Yes | Third cycle (N = 207): No | Third cycle (N = 207): Missing data |
|---|
| NuvaRing | 208 | 16 | 28 | 197 | 13 | 3 | 193 | 13 | 1 |
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)
| Intervention | Participants (Number) |
|---|
| First cycle: Total bleeding/spotting | First cycle: Bleeding | First cycle: Spotting | Second cycle: Total bleeding/spotting | Second cycle: Bleeding | Second cycle: Spotting | Third cycle: Total bleeding/spotting | Third cycle: Bleeding | Third cycle: Spotting |
|---|
| NuvaRing | 5 | 1 | 4 | 0 | 0 | 0 | 1 | 0 | 1 |
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)
| Intervention | Participants (Number) |
|---|
| First cycle: Regular | First cycle: Irregular | First cycle: Missing data | Second cycle: Regular | Second cycle: Irregular | Second cycle: Missing data | Third cycle: Regular | Third cycle: Irregular | Third cycle: Missing data |
|---|
| NuvaRing | 192 | 9 | 3 | 199 | 4 | 1 | 200 | 3 | 1 |
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)
| Intervention | Pregnancies (Number) |
|---|
| First cycle (N = 252): Yes | First cycle (N = 252): No | First cycle (N = 252): Missing data | Second cycle (N = 213): Yes | Second cycle (N = 213): No | Second cycle (N = 213): Missing data | Third cycle (N = 207): Yes | Third cycle (N = 207): No | Third cycle (N = 207): Missing data |
|---|
| NuvaRing | 0 | 226 | 26 | 0 | 210 | 3 | 0 | 207 | 0 |
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)
| Intervention | Days (Mean) |
|---|
| First cycle (N = 4) | Second cycle (N = 0) | Third cycle (N = 1) |
|---|
| NuvaRing | 5.5 | 0 | 3 |
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)
| Intervention | Participants (Number) |
|---|
| First cycle: Very easy | First cycle: Easy | First cycle: Neutral | First cycle: Difficult | First cycle: Very difficult | First cycle: Failed | Second cycle: Very easy | Second cycle: Easy | Second cycle: Neutral | Second cycle: Difficult | Second cycle: Very difficult | Second cycle: Failed | Third cycle: Very easy | Third cycle: Easy | Third cycle: Neutral | Third cycle: Difficult | Third cycle: Very difficult | Third cycle: Failed |
|---|
| NuvaRing | 59 | 82 | 59 | 4 | 0 | 0 | 73 | 105 | 20 | 6 | 0 | 0 | 78 | 113 | 12 | 1 | 0 | 0 |
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)
| Intervention | Participants (Number) |
|---|
| First cycle: Never | First cycle: Rarely | First cycle: Occasionally | First cycle: Mostly | First cycle: Always | Second cycle: Never | Second cycle: Rarely | Second cycle: Occasionally | Second cycle: Mostly | Second cycle: Always | Third cycle: Never | Third cycle: Rarely | Third cycle: Occasionally | Third cycle: Mostly | Third cycle: Always |
|---|
| NuvaRing | 87 | 89 | 25 | 1 | 2 | 107 | 86 | 8 | 2 | 1 | 117 | 79 | 5 | 3 | 0 |
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)
| Intervention | Participants (Number) |
|---|
| First cycle: Never | First cycle: Rarely | First cycle: Occasionally | First cycle: Mostly | First cycle: Always | Second cycle: Never | Second cycle: Rarely | Second cycle: Occasionally | Second cycle: Mostly | Second cycle: Always | Third cycle: Never | Third cycle: Rarely | Third cycle: Occasionally | Third cycle: Mostly | Third cycle: Always |
|---|
| NuvaRing | 85 | 81 | 33 | 3 | 2 | 100 | 82 | 21 | 0 | 1 | 125 | 69 | 9 | 0 | 1 |
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)
| Intervention | Participants (Number) |
|---|
| First cycle (N = 252): Very satisfied | First cycle (N = 252): Satisfied | First cycle (N = 252): Neutral | First cycle (N = 252): Unsatisfied | First cycle (N = 252): Very unsatisfied | First cycle (N = 252): Missing data | Second cycle (N = 213): Very satisfied | Second cycle (N = 213): Satisfied | Second cycle(N = 213): Neutral | Second cycle (N = 213): Unsatisfied | Second cycle (N = 213): Very unsatisfied | Second cycle (N = 213): Missing data | Third cycle (N = 207): Very satisfied | Third cycle (N = 207): Satisfied | Third cycle (N = 207): Neutral | Third cycle (N = 207): Unsatisfied | Third cycle (N = 207): Very unsatisfied | Third cycle (N = 207): Missing data |
|---|
| NuvaRing | 68 | 119 | 28 | 9 | 1 | 27 | 82 | 112 | 15 | 1 | 0 | 3 | 88 | 107 | 9 | 1 | 1 | 1 |
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)
| Intervention | Participants (Number) |
|---|
| First cycle: Very easy | First cycle: Easy | First cycle: Neutral | First cycle: Difficult | First cycle: Very difficult | First cycle: Failed | Second cycle: Very easy | Second cycle: Easy | Second cycle: Neutral | Second cycle: Difficult | Second cycle: Very difficult | Second cycle: Failed | Third cycle: Very easy | Third cycle: Easy | Third cycle: Neutral | Third cycle: Difficult | Third cycle: Very different | Third cycle: Failed |
|---|
| NuvaRing | 70 | 128 | 6 | 0 | 0 | 0 | 81 | 119 | 4 | 0 | 0 | 0 | 88 | 113 | 2 | 1 | 0 | 0 |
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)
| Intervention | Participants (Number) |
|---|
| NuvaRing | 0 |
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)
| Intervention | Participants (Number) |
|---|
| NuvaRing | 47 |
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)
| Intervention | Days (Mean) |
|---|
| First cycle (N = 201) | Second cycle (N = 203) | Third cycle (N = 203) |
|---|
| NuvaRing | 3.8 | 3.7 | 3.6 |
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)
| Intervention | Pads (Median) |
|---|
| First cycle (N = 201) | Second cycle (N = 203) | Third cycle (N = 203) |
|---|
| NuvaRing | 2 | 2 | 2 |
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)
| Intervention | Participants (Number) |
|---|
| First cycle: Never | First cycle: Rarely | First cycle: Occasionally | First cycle: Mostly | First cycle: Always | Second cycle: Never | Second cycle: Rarely | Second cycle: Occasionally | Second cycle: Mostly | Second cycle: Always | Third cycle: Never | Third cycle: Rarely | Third cycle: Occasionally | Third cycle: Mostly | Third cycle: Always |
|---|
| NuvaRing | 88 | 75 | 34 | 5 | 2 | 112 | 65 | 23 | 3 | 1 | 121 | 69 | 10 | 3 | 1 |
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)
| Intervention | Participants (Number) |
|---|
| First cycle: Never | First cycle: Rarely | First cycle: Occasionally | First cycle: Mostly | First cycle: Always | Second cycle: Never | Second cycle: Rarely | Second cycle: Occasionally | Second cycle: Mostly | Second cycle: Always | Third cycle: Never | Third cycle: Rarely | Third cycle: Occasionally | Third cycle: Mostly | Third cycle: Always |
|---|
| NuvaRing | 129 | 70 | 4 | 1 | 0 | 143 | 55 | 5 | 1 | 0 | 153 | 45 | 3 | 3 | 0 |
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)
| Intervention | Days (Mean) |
|---|
| First cycle | Second cycle | Third cycle |
|---|
| NuvaRing | 4 | 0 | 0 |
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
| Intervention | pg/mL (Median) |
|---|
| NuvaRing and no ART | 21.30 |
| NuvaRing With EFV Plus ≥2 NRTIs | 11.40 |
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 16.05 |
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
| Intervention | pg/mL (Median) |
|---|
| NuvaRing and no ART | 1860.00 |
| NuvaRing With EFV Plus ≥2 NRTIs | 429.00 |
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 3290.00 |
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)
| Intervention | h*ng/mL (Median) |
|---|
| AUC0-24h day 0 | AUC0-24h day 21 |
|---|
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 44313.7 | 36764.7 |
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).
| Intervention | L/h (Median) |
|---|
| CLss/F day 0 | CLss/F day 21 |
|---|
| NuvaRing With ATV/r Plus TDF ≥1 NRTIs | 6.8 | 8.2 |
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).
| Intervention | ng/mL (Median) |
|---|
| Cmax day 0 | Cmax day 21 |
|---|
| NuvaRing With ATV/r Plus TDF ≥1 NRTIs | 4291.0 | 3583.0 |
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).
| Intervention | ng/mL (Median) |
|---|
| Cmin day 0 | Cmin day 21 |
|---|
| NuvaRing With ATV/r Plus TDF ≥1 NRTIs | 796.7 | 599.4 |
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).
| Intervention | hour (Median) |
|---|
| Tmax day 0 | Tmax day 21 |
|---|
| NuvaRing With ATV/r Plus TDF ≥1 NRTIs | 2.9 | 3.0 |
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)
| Intervention | hour (Median) |
|---|
| Tmax day 0 | Tmax day 21 |
|---|
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 3.0 | 3.0 |
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
| Intervention | pg/mL (Median) |
|---|
| Concentration at Day 7 | Concentration at Day 14 |
|---|
| NuvaRing and no ART | 18.05 | 19.70 |
,| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 15.70 | 16.55 |
,| NuvaRing With EFV Plus ≥2 NRTIs | 9.98 | 10.50 |
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
| Intervention | pg/mL (Median) |
|---|
| Concentration at Day 7 | Concentration at Day 14 |
|---|
| NuvaRing and no ART | 1970.00 | 2070.00 |
,| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 3250.00 | 3530.00 |
,| NuvaRing With EFV Plus ≥2 NRTIs | 427.00 | 437.00 |
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
| Intervention | proportion of participants (Number) |
|---|
| Proportion with HIV-1 RNA <40 copies/mL at day 0 | Proportion with HIV-1 RNA <40 copies/mL at day 21 |
|---|
| NuvaRing and no ART | 0.22 | 0.17 |
,| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 0.89 | 0.85 |
,| NuvaRing With EFV Plus ≥2 NRTIs | 0.93 | 0.85 |
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
| Intervention | proportion of participants (Number) |
|---|
| Proportion with progesterone >5 at day 0 | Proportion with progesterone >5 at day 7 | Proportion with progesterone >5 at day 14 | Proportion with progesterone >5 at day 21 | Proportion with progesterone >5 at day 28 |
|---|
| NuvaRing and no ART | 0.08 | 0.08 | 0.00 | 0.00 | 0.00 |
,| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 0.25 | 0.08 | 0.00 | 0.00 | 0.00 |
,| NuvaRing With EFV Plus ≥2 NRTIs | 0.04 | 0.24 | 0.04 | 0.00 | 0.00 |
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)
| Intervention | h*ng/mL (Median) |
|---|
| AUC0-24h day 0 | AUC0-24h day 21 |
|---|
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 10740.0 | 7210.7 |
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).
| Intervention | ng/mL (Median) |
|---|
| Cmin day 0 | Cmin day 21 |
|---|
| NuvaRing With EFV Plus ≥2 NRTIs | 2121.5 | 1766.0 |
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)
| Intervention | hour (Median) |
|---|
| CLss/F day 0 | CLss/F day 21 |
|---|
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 9.3 | 13.9 |
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)
| Intervention | ng/mL (Median) |
|---|
| Cmax day 0 | Cmax day 21 |
|---|
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 1437.0 | 1063.0 |
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)
| Intervention | ng/mL (Median) |
|---|
| Cmin day 0 | Cmin day 21 |
|---|
| NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 70.0 | 51.9 |
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).
| Intervention | ng/mL (Median) |
|---|
| Cmax day 0 | Cmax day 21 |
|---|
| NuvaRing With EFV Plus ≥2 NRTIs | 4541.0 | 3786.0 |
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).
| Intervention | L/h (Median) |
|---|
| CLss/F day 0 | CLss/F day 21 |
|---|
| NuvaRing With EFV Plus ≥2 NRTIs | 8.7 | 10.4 |
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).
| Intervention | h*ng/mL (Median) |
|---|
| AUC0-24h day 0 | AUC0-24h day 21 |
|---|
| NuvaRing With EFV Plus ≥2 NRTIs | 68949.1 | 57795.9 |
Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion
Participants completed a Follow-Up Questionnaire in which they asked if they experienced vaginal ring expulsion. Their answers were recorded and evaluated. (NCT02275546)
Timeframe: Up to 48 hours after vaginal ring insertion
| Intervention | Percentage of participants (Number) |
|---|
| Applicator | 0 |
| No Applicator (Manual) | 0 |
Percentage of Participants With Successful Ring Insertion
Participants completed a Post-Insertion Questionnaire in which they were asked about their experience inserting the vaginal ring. Their answers were recorded and evaluated. (NCT02275546)
Timeframe: Day 1 (immediately after vaginal ring insertion)
| Intervention | Percentage of participants (Number) |
|---|
| Applicator | 100 |
| No Applicator (Manual) | 100 |
Changes in Insulin-like Growth Factor-1 (IGF-1), IGF Binding Proteins (IGFBP-1, IGFBP-3), and Acid Labile Subunit (ALS)
Changes in serially-sampled fasting serum concentrations of insulin-like growth factor-1 (IGF-1) before and after 49 days of contraceptive therapy. Data were only collected for IGF-1 levels, no assays were performed for IGFBP-1, IGFBP-3, and acid labile subunit (ALS) and no raw data were collected due to insufficient funds. (NCT02367833)
Timeframe: Baseline and post-49 days of contraceptive therapy
| Intervention | ng/mL (Mean) |
|---|
| Baseline IGF-1 Concetration | Post-Therapy IGF-1 Concentration |
|---|
| Combined Oral Contraceptives (COC) | 228.7 | 185.9 |
,| Contraceptive Vaginal Ring (CVR) | 197.1 | 175.2 |
,| Control Group | 220.6 | 221.4 |