Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring
NCT ID: NCT03432416
Last Updated: 2025-10-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
385 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-02-12
Study Completion Date
2021-12-14
Brief Summary
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This will be a multi-site, open-label, randomized clinical trial. The investigators will randomize 300 eligible participants in a 1:1 ratio to two different treatment regimens that are to be followed when using a contraceptive vaginal ring delivering a daily dose of Nestorone® and estradiol (NES-E2 CVR).
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Detailed Description
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The total duration of the study for each participant is expected to be approximately 13.5-15.5 months: including screening and enrollment (up to 8 weeks), 12 months of participation, and a post-removal follow up period removal of at least 17 days. After enrollment, subject visits occur at day 31, 92, 183, 274, and 364 with telephone calls at day 60, 120, 150, 210, 240, 300, and 330. Subjects will use a home pregnancy test 17 days post-removal of the ring and will call the site report the result and for safety follow-up. Another phone call will be required after that if the subject chooses not to being a hormonal contraceptive; this call will occur at the time of the subject's first spontaneous menses.
Subject recruitment is expected to begin Q1 (in the first quarter of) 2018 and is planned to continue through Q1 2019. However, if the enrollment rate declines, the enrollment period may be extended beyond this date. If this enrollment timeline is met, all subjects should finish active treatment by approximately the end of Q1 2020. The end of the study will occur when the last subject to be enrolled has completed her post-removal telephone call(s).
Preliminary results of the study are expected to be available Q3 of 2020 based on the current study plan.
Subject recruitment is expected to begin Q1 (in the first quarter of) 2018 and is planned to continue through Q1 2019. However, if the enrollment rate declines, the enrollment period may be extended beyond this date. If this enrollment timeline is met, all subjects should finish active treatment by approximately the end of Q1 2020. The end of the study will occur when the last subject to be enrolled has completed her post-removal telephone call(s).
Preliminary results of the study are expected to be available Q3 of 2020 based on the current study plan.
Conditions
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Healthy Women
Female Contraception
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Regimen 1: Continuous Usage
Contraceptive vaginal ring delivering a daily dose of Nestorone® and estradiol (NES-E2 CVR) worn continuously for 91 days.
Group Type
EXPERIMENTAL
NES-E2 CVR
Intervention Type
DRUG
NES-E2 CVR
Regimen 2: Cyclical Usage
Contraceptive vaginal ring delivering a daily dose of Nestorone® and estradiol (NES-E2 CVR) worn for 91 days, but is removed for 2 days each month (days 29-30, 59-60, and 90-91).
Group Type
EXPERIMENTAL
NES-E2 CVR
Intervention Type
DRUG
NES-E2 CVR
Interventions
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NES-E2 CVR
NES-E2 CVR
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Good general overall health with no chronic medical conditions that result in periodic exacerbations requiring significant medical care.
2. Age 18-35 years, inclusive, at the enrollment visit. (Note: subjects must be at least 18 years of age to provide consent.)
3. Have a regular menstrual cycle 21-35 days in duration when not using hormonal contraception
4. Have an intact uterus and at least one ovary.
5. Consistent use of effective contraception during the preceding cycle with no unprotected intercourse since last use (NOTE: women who use oral, transdermal, vaginal, or implantable hormonal contraceptives in the preceding cycle must have discontinued hormone use at least 4 days prior to start of treatment and must not have had unprotected intercourse since discontinuing the method. Copper IUD or Levonorgestrel releasing IUD users must have discontinued IUD use at least 4 days prior to start of treatment and have experienced a spontaneous menses following IUD removal.)
6. No use of injectable contraceptives (e.g. depomedroxyprogesterone acetate) during the 10 months prior to screening unless the subject has returned to normal menses (two consecutive menses) since last injection.
7. Have a negative pregnancy test at the enrollment visit.
8. Have a diastolic blood pressure (BP) \<90 mm Hg and systolic BP \<140 mm Hg after 5 minutes rest in sitting position at the admission visit (below hypertension stage 2). (Note: History of hypertension stage 2 or higher, even if controlled with treatment, is exclusionary.)
9. Willing to abstain from use of non-water based (including silicone based) vaginal lubricants during the study that could adversely affect the ring, causing it to expand.
10. Understand and sign an IRB-approved informed consent form prior to screening activities (including fasting blood draws).
11. BMI ≤ 35 kg/m2 and not having previously undergone bariatric surgery.
12. Planning to have at least one act of heterosexual intercourse without the use of another contraceptive method each month during study participation until end of treatment and at risk for pregnancy.
2. Age 18-35 years, inclusive, at the enrollment visit. (Note: subjects must be at least 18 years of age to provide consent.)
3. Have a regular menstrual cycle 21-35 days in duration when not using hormonal contraception
4. Have an intact uterus and at least one ovary.
5. Consistent use of effective contraception during the preceding cycle with no unprotected intercourse since last use (NOTE: women who use oral, transdermal, vaginal, or implantable hormonal contraceptives in the preceding cycle must have discontinued hormone use at least 4 days prior to start of treatment and must not have had unprotected intercourse since discontinuing the method. Copper IUD or Levonorgestrel releasing IUD users must have discontinued IUD use at least 4 days prior to start of treatment and have experienced a spontaneous menses following IUD removal.)
6. No use of injectable contraceptives (e.g. depomedroxyprogesterone acetate) during the 10 months prior to screening unless the subject has returned to normal menses (two consecutive menses) since last injection.
7. Have a negative pregnancy test at the enrollment visit.
8. Have a diastolic blood pressure (BP) \<90 mm Hg and systolic BP \<140 mm Hg after 5 minutes rest in sitting position at the admission visit (below hypertension stage 2). (Note: History of hypertension stage 2 or higher, even if controlled with treatment, is exclusionary.)
9. Willing to abstain from use of non-water based (including silicone based) vaginal lubricants during the study that could adversely affect the ring, causing it to expand.
10. Understand and sign an IRB-approved informed consent form prior to screening activities (including fasting blood draws).
11. BMI ≤ 35 kg/m2 and not having previously undergone bariatric surgery.
12. Planning to have at least one act of heterosexual intercourse without the use of another contraceptive method each month during study participation until end of treatment and at risk for pregnancy.
Exclusion Criteria
1. Planning pregnancy during study participation through the end of treatment visit.
2. Within 30 days post-partum, currently breast-feeding, or has not had a spontaneous menses.
3. Post-abortal and has not had a spontaneous menses.
4. Abnormal genital bleeding.
5. Participating in another clinical trial involving an investigational product within the last 30 days (prior to screening) or planning to participate in another clinical trial during this study.
6. Not living in the catchment area of the study site.
7. Known hypersensitivity to progestins or estrogens.
8. Contraindications to combined estrogen-progestin contraceptive use including:
1. Thrombophlebitis or thromboembolic disorders.
2. Personal history of deep vein thrombophlebitis or thromboembolic disorders.
3. History of venous thrombosis or embolism in a first-degree relative \<55 years of age suggesting a familial defect in the blood coagulation system.
4. History of thrombosis or embolism OR any other personal or family history which in the opinion of the investigator suggests increased risk.
5. History of stroke.
6. Known history of any of the following genetic mutations: Factor V Leiden mutation, prothrombin mutation, antithrombin deficiency, or other clinically significant thrombophilia.
7. Known or suspected carcinoma of the breast.
8. Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasm.
9. History of cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use.
10. History of hepatic adenomas or carcinomas.
11. Known or suspected pregnancy.
12. Smoking in women who are or will be 35 years during the course of the trial; women \<35 years who smoke 15 cigarettes or more per day must be evaluated by the investigator for inclusion based on risk factors that would increase their risk for cardiovascular disease (CVD) and thromboembolism, e.g. lipid levels, glucose level, BP, BMI, family history of CVD at a young age. Individuals who use other forms of tobacco should be evaluated similarly by the investigator for inclusion based on the amount of tobacco use and their risk factors.
13. History of retinal vascular lesions, unexplained partial or complete loss of vision.
14. History of headaches with focal neurological symptoms (e.g., migraines with auras).
15. Impaired mobility (e.g. wheelchair bound, bed-ridden) that, in the opinion of the investigator, places the woman at increased risk of thrombosis.
9. Unevaluated vaginal discharge or vaginal lesions. Subjects diagnosed at screening with a chlamydia or gonococcal infection may be included in the trial following treatment completion; partner treatment is also recommended. Subjects with yeast, trichomoniasis, or bacterial vaginosis infection requiring treatment may be enrolled after treatment completion. Investigators should determine if subjects are at an elevated risk for reinfection, e.g. multiple sex partners, untreated partner, and whether such subjects can be included. Women with a history of genital herpes can be included if outbreaks are infrequent.
10. Have a known clinically significant Pap test abnormality, as managed by normal standard of care guidelines, that would require repeat evaluation or treatment during study participation based on the initial Pap findings.
11. Known benign or malignant liver tumors, renal disease or active liver disease.
12. Invasive cancer (past history of any carcinoma or sarcoma, except non-melanoma skin cancer).
13. Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive.
14. Known or suspected current alcohol dependence, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of study product and/or study treatment compliance. A chronic marijuana user is defined as someone who uses marijuana 4 or more times per week for study purposes.
15. Elevated fasting clinical chemistry values or complete blood count (CBC) values designated clinically significant by the investigator or medically qualified sub-investigator.
16. Uncontrolled thyroid disease.
17. Known impaired hypothalamic-pituitary-adrenal axis.
18. Known hypersensitivity to silicone rubber.
19. History of toxic shock syndrome.
20. Vaginal anatomic abnormality such as cystocele or rectocele that would preclude correct use of a vaginal ring.
21. Planning major surgery during study participation.
22. Severe current constipation.
23. Use of liver enzyme inducers or inhibitors on a regular basis.
24. Known HIV infection.
25. Use of any medications, including antibiotics that can significantly interfere with the metabolism of hormonal contraceptives.
26. Have an anticipated need for regular condom use, defined as use of at least one condom per month after enrollment.
27. Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
28. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.
2. Within 30 days post-partum, currently breast-feeding, or has not had a spontaneous menses.
3. Post-abortal and has not had a spontaneous menses.
4. Abnormal genital bleeding.
5. Participating in another clinical trial involving an investigational product within the last 30 days (prior to screening) or planning to participate in another clinical trial during this study.
6. Not living in the catchment area of the study site.
7. Known hypersensitivity to progestins or estrogens.
8. Contraindications to combined estrogen-progestin contraceptive use including:
1. Thrombophlebitis or thromboembolic disorders.
2. Personal history of deep vein thrombophlebitis or thromboembolic disorders.
3. History of venous thrombosis or embolism in a first-degree relative \<55 years of age suggesting a familial defect in the blood coagulation system.
4. History of thrombosis or embolism OR any other personal or family history which in the opinion of the investigator suggests increased risk.
5. History of stroke.
6. Known history of any of the following genetic mutations: Factor V Leiden mutation, prothrombin mutation, antithrombin deficiency, or other clinically significant thrombophilia.
7. Known or suspected carcinoma of the breast.
8. Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasm.
9. History of cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use.
10. History of hepatic adenomas or carcinomas.
11. Known or suspected pregnancy.
12. Smoking in women who are or will be 35 years during the course of the trial; women \<35 years who smoke 15 cigarettes or more per day must be evaluated by the investigator for inclusion based on risk factors that would increase their risk for cardiovascular disease (CVD) and thromboembolism, e.g. lipid levels, glucose level, BP, BMI, family history of CVD at a young age. Individuals who use other forms of tobacco should be evaluated similarly by the investigator for inclusion based on the amount of tobacco use and their risk factors.
13. History of retinal vascular lesions, unexplained partial or complete loss of vision.
14. History of headaches with focal neurological symptoms (e.g., migraines with auras).
15. Impaired mobility (e.g. wheelchair bound, bed-ridden) that, in the opinion of the investigator, places the woman at increased risk of thrombosis.
9. Unevaluated vaginal discharge or vaginal lesions. Subjects diagnosed at screening with a chlamydia or gonococcal infection may be included in the trial following treatment completion; partner treatment is also recommended. Subjects with yeast, trichomoniasis, or bacterial vaginosis infection requiring treatment may be enrolled after treatment completion. Investigators should determine if subjects are at an elevated risk for reinfection, e.g. multiple sex partners, untreated partner, and whether such subjects can be included. Women with a history of genital herpes can be included if outbreaks are infrequent.
10. Have a known clinically significant Pap test abnormality, as managed by normal standard of care guidelines, that would require repeat evaluation or treatment during study participation based on the initial Pap findings.
11. Known benign or malignant liver tumors, renal disease or active liver disease.
12. Invasive cancer (past history of any carcinoma or sarcoma, except non-melanoma skin cancer).
13. Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive.
14. Known or suspected current alcohol dependence, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of study product and/or study treatment compliance. A chronic marijuana user is defined as someone who uses marijuana 4 or more times per week for study purposes.
15. Elevated fasting clinical chemistry values or complete blood count (CBC) values designated clinically significant by the investigator or medically qualified sub-investigator.
16. Uncontrolled thyroid disease.
17. Known impaired hypothalamic-pituitary-adrenal axis.
18. Known hypersensitivity to silicone rubber.
19. History of toxic shock syndrome.
20. Vaginal anatomic abnormality such as cystocele or rectocele that would preclude correct use of a vaginal ring.
21. Planning major surgery during study participation.
22. Severe current constipation.
23. Use of liver enzyme inducers or inhibitors on a regular basis.
24. Known HIV infection.
25. Use of any medications, including antibiotics that can significantly interfere with the metabolism of hormonal contraceptives.
26. Have an anticipated need for regular condom use, defined as use of at least one condom per month after enrollment.
27. Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
28. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.
Minimum Eligible Age
18 Years
Maximum Eligible Age
35 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sponsor Role
collaborator
Population Council
OTHER
Sponsor Role
collaborator
Premier Research
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Essential Access Health
Los Angeles, California, United States
Site Status
University of California, Davis
Sacramento, California, United States
Site Status
University of Colorado Denver
Aurora, Colorado, United States
Site Status
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Site Status
Bellevue Hospital Center
New York, New York, United States
Site Status
Columbia University
New York, New York, United States
Site Status
University of Cincinnati
Cincinnati, Ohio, United States
Site Status
Oregon Health Science University
Portland, Oregon, United States
Site Status
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States
Site Status
University of Utah
Salt Lake City, Utah, United States
Site Status
Eastern Virginia Medical School
Norfolk, Virginia, United States
Site Status
Countries
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United States
References
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Sitruk-Ware R. Pharmacological profile of progestins. Maturitas. 2008 Sep-Oct;61(1-2):151-7. doi: 10.1016/j.maturitas.2008.11.011.
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Heikinheimo O, Ranta S, Moo-Young A, Lahteenmaki P, Gordon K. Parenteral administration of progestin Nestorone to lactating cynomolgus monkeys: an ideal hormonal contraceptive at lactation? Hum Reprod. 1999 Aug;14(8):1993-7. doi: 10.1093/humrep/14.8.1993.
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Sivin I, Mishell DR Jr, Alvarez F, Brache V, Elomaa K, Lahteenmaki P, Massai R, Miranda P, Croxatto H, Dean C, Small M, Nash H, Jackanicz TM. Contraceptive vaginal rings releasing Nestorone and ethinylestradiol: a 1-year dose-finding trial. Contraception. 2005 Feb;71(2):122-9. doi: 10.1016/j.contraception.2004.08.010.
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Weisberg E, Brache V, Alvarez F, Massai R, Mishell DR Jr, Apter D, Gale J, Sivin I, Tsong YY, Fraser IS. Clinical performance and menstrual bleeding patterns with three dosage combinations of a Nestorone progestogen/ethinyl estradiol contraceptive vaginal ring used on a bleeding-signaled regimen. Contraception. 2005 Jul;72(1):46-52. doi: 10.1016/j.contraception.2004.12.014.
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Rad M, Kluft C, Menard J, Burggraaf J, de Kam ML, Meijer P, Sivin I, Sitruk-Ware RL. Comparative effects of a contraceptive vaginal ring delivering a nonandrogenic progestin and continuous ethinyl estradiol and a combined oral contraceptive containing levonorgestrel on hemostasis variables. Am J Obstet Gynecol. 2006 Jul;195(1):72-7. doi: 10.1016/j.ajog.2005.12.007. Epub 2006 Mar 20.
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Kluft C, Meijer P, LaGuardia KD, Fisher AC. Comparison of a transdermal contraceptive patch vs. oral contraceptives on hemostasis variables. Contraception. 2008 Feb;77(2):77-83. doi: 10.1016/j.contraception.2007.10.004. Epub 2008 Jan 11.
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BACKGROUND
Mashchak CA, Lobo RA, Dozono-Takano R, Eggena P, Nakamura RM, Brenner PF, Mishell DR Jr. Comparison of pharmacodynamic properties of various estrogen formulations. Am J Obstet Gynecol. 1982 Nov 1;144(5):511-8. doi: 10.1016/0002-9378(82)90218-6.
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Marty JP, James M, Hajo N, Wepierre J Percutaneous absorption of oestradiol and progesterone: Pharmacokinetic studies. In P Mauvais-Jarvis, CFH Vickers, J Wepierre (Eds), Percutaneous absorption of steroids. London: Academic Press Inc. (London) Ltd. 1980.
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Timmer CJ, Mulders TM. Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring. Clin Pharmacokinet. 2000 Sep;39(3):233-42. doi: 10.2165/00003088-200039030-00005.
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Merkatz RB, Plagianos M, Hoskin E, Cooney M, Hewett PC, Mensch BS. Acceptability of the Nestorone(R)/ethinyl estradiol contraceptive vaginal ring: development of a model; implications for introduction. Contraception. 2014 Nov;90(5):514-21. doi: 10.1016/j.contraception.2014.05.015. Epub 2014 Jun 2.
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Isidori AM, Pozza C, Esposito K, Giugliano D, Morano S, Vignozzi L, Corona G, Lenzi A, Jannini EA. Development and validation of a 6-item version of the female sexual function index (FSFI) as a diagnostic tool for female sexual dysfunction. J Sex Med. 2010 Mar;7(3):1139-46. doi: 10.1111/j.1743-6109.2009.01635.x. Epub 2009 Dec 1.
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Borch KH, Braekkan SK, Mathiesen EB, Njolstad I, Wilsgaard T, Stormer J, Hansen JB. Anthropometric measures of obesity and risk of venous thromboembolism: the Tromso study. Arterioscler Thromb Vasc Biol. 2010 Jan;30(1):121-7. doi: 10.1161/ATVBAHA.109.188920. Epub 2009 Oct 15.
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Pomp ER, le Cessie S, Rosendaal FR, Doggen CJ. Risk of venous thrombosis: obesity and its joint effect with oral contraceptive use and prothrombotic mutations. Br J Haematol. 2007 Oct;139(2):289-96. doi: 10.1111/j.1365-2141.2007.06780.x.
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Simmons KB, Kumar N, Plagianos M, Roberts K, Hoskin E, Han L, Alami M, Creasy G, Variano B, Merkatz R. Effects of concurrent vaginal miconazole treatment on the absorption and exposure of Nestorone(R) (segesterone acetate) and ethinyl estradiol delivered from a contraceptive vaginal ring: a randomized, crossover drug-drug interaction study. Contraception. 2018 Mar;97(3):270-276. doi: 10.1016/j.contraception.2017.10.010. Epub 2017 Oct 31.
Reference Type
BACKGROUND
Other Identifiers
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CCN012B
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
PHASE2
A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)
NCT01709318
COMPLETED
PHASE2
An Open-label Study to Evaluate the Effects of Concurrent Administration of Vaginal Antimycotic Medication Miconazole Nitrate on the Pharmacokinetics of Nestorone and Ethinyl Estradiol Delivered by a Contraceptive Vaginal Ring in Normal Ovulating Women
NCT02215395
COMPLETED
PHASE1
Study of Safety and Efficacy of an Oral Contraceptive
NCT00932321
COMPLETED
PHASE3
Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
NCT00245921
COMPLETED
PHASE3
Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring in Women at Risk for Pregnancy (MK-8342B-061)
NCT02524288
TERMINATED
PHASE3
"Quick-starting" of a New Combined Hormonal Contraceptive Pills, 15 mg Estetrol/3 mg Drospirenone VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition
NCT06396221
COMPLETED
NA
Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens
NCT00805415
COMPLETED
PHASE2
Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception
NCT00248963
COMPLETED
PHASE3
Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
NCT00254189
COMPLETED
PHASE2
"Quick-starting" of a Quadriphasic Contraceptive Pills, 1 - 3 mg Estradiol Valerate/ 2 - 3 mg Dienogest VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition
NCT06396208
COMPLETED
NA
Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring (MK-8342B) in Women With Primary Dysmenorrhea (With Optional Extension) (MK-8342B-059)
NCT02668783
TERMINATED
PHASE3
Ethylvinyl Acetate (EVA) Vaginal Ring Delivery System Study
NCT00706784
TERMINATED
PHASE1/PHASE2
Performance and Safety of Vaginal Ring Applicator in Healthy Females (MK-8342A-063)
NCT02275546
COMPLETED
PHASE3
Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
NCT00196326
COMPLETED
PHASE3
Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids
NCT04267250
COMPLETED
PHASE1
Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder
NCT00128934
COMPLETED
PHASE3
Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert
NCT06668896
NOT_YET_RECRUITING
PHASE1
A Multi-center, Open-label, Randomized, Parallel Group Study to Evaluate Pharmacokinetic Profile, Effects on the Mechanisms of Contraceptive Efficacy and Safety of Two Progestin-only Patches Containing Different Doses of Levonorgestrel (LNG)
NCT01166412
COMPLETED
PHASE1/PHASE2
Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring (MK-8342B) in the Treatment of Women With Primary Dysmenorrhea (MK-8342B-060)
NCT02668822
TERMINATED
PHASE3
The Effect of BMS-986142 on the Pharmacokinetics of a Combined Oral Contraceptive (OC) Containing Ethinyl Estradiol (EE) and Norethindrone Acetate (NET) in Healthy Female Subjects
NCT02832180
COMPLETED
PHASE1
Evaluation of Pharmacodynamic Effects on Ovulation and Cycle Control
NCT01250210
COMPLETED
PHASE2
A Phase 2, Dose-finding, Cross-over Study to Evaluate the Effect of a NES/E2 Transdermal Gel Delivery on Ovulation Suppression in Normal Ovulating Women
NCT00796133
COMPLETED
PHASE2
A Study to Determine the Effects of PF-04965842 on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Subjects
NCT03662516
COMPLETED
PHASE1
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
NCT00212342
COMPLETED
PHASE3