Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring
A Multicenter, Open-label Study on the Efficacy, Cycle Control and Safety of a Contraceptive Vaginal Ring Delivering a Daily Dose of 150µg of Nestorone® and 15µg of Ethinyl Estradiol (150/15 NES/EE CVR)
1 other identifier
interventional
1,200
1 country
15
Brief Summary
The purpose of this study is to evaluate the one-year data on the contraceptive efficacy and safety of the 150/15 NES/EE CVR as the basis for regulatory approvals of this CVR as a new delivery system for contraception.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2006
Longer than P75 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 2, 2007
CompletedFirst Posted
Study publicly available on registry
April 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
January 23, 2026
CompletedJanuary 23, 2026
January 1, 2026
2.1 years
April 2, 2007
November 22, 2023
January 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Contraceptive Efficacy Using the Pearl Index for All Subjects
The Pearl Index derived from using all cycles for which back up contraception is not used will be the primary efficacy endpoint. The Pearl Index is used to indicate how many women out of 100 would get pregnant using a specific birth control method over a year. It uses the formula: (Pregnancies x 12 x 100) / (Women x Months of study). The lower the Pearl Index, the more effective the contraceptive.
12 Months
Changes From Baseline in Pap Smear
Changes from Baseline in Pap Smear results as measured at Screening (Baseline) and at Visit 5 (Cycle 13)
Visit 0 and Visit 5, up to 13 months
Contraceptive Efficacy Using the Pearl Index for Subjects Less Than or Equal to 35 Years of Age
The Pearl Index derived from using all cycles for which back up contraception is not used will be the primary efficacy endpoint and analyzed for subjects that are less than or equal to 35 years of age. The Pearl Index is used to indicate how many women out of 100 would get pregnant using a specific birth control method over a year. It uses the formula: (Pregnancies x 12 x 100) / (Women x Months of study). The lower the Pearl Index, the more effective the contraceptive.
12 Months
Secondary Outcomes (4)
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days
Cycles 1-13, up to 13 months
Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days
Cycles 1-13, up to 13 months
Return to Fertility Assessed by Intended Pregnancies
Up to 6 Months
Number of Participants With Return of Post-Treatment Menses Within 6 Months
Up to 6 Months
Study Arms (1)
150/15 NES/EE CVR
EXPERIMENTAL150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
Interventions
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
Eligibility Criteria
You may qualify if:
- Healthy women, aged 18-\<40 years who wish to use a combined hormonal contraceptive.
- Women not intending to become pregnant for 13 months.
- Intact uterus and both ovaries.
- Prior history of regular menstrual cycles of 28 ± 7 days when not using hormonal contraception; if postpartum or postabortal, history of regular menstrual cycles of 21-35 days in length and at least one cycle (2 menses) with a cycle length consistent with her past cycles.
- Sexually active (currently) and willing to discontinue current contraceptive method to participate in the study.
- In the opinion of the investigator, able to comply with the protocol, e.g. live within the study site catchment area or within a reasonable distance from the site.
You may not qualify if:
- Signed informed consent prior to entry into the trial.
- Known hypersensitivity to estrogens or progestins.
- Known hypersensitivity to silicone rubber.
- Known or suspected pregnancy.
- History of infertility of \>1.0 year in woman or her male partner.
- History of vasectomy or sterility in male partner; tubal ligation (sterilization) in women
- Undiagnosed abnormal genital bleeding.
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities. (Subjects diagnosed at screening with Chlamydia or gonorrhea may be included in the trial following treatment; partner treatment is also recommended. Investigators should make a determination if subjects are at high risk for reinfection, e.g. multiple sex partners, untreated partner, and whether such subjects can be included.)
- History of pelvic inflammatory disease since last pregnancy episode.
- History of toxic shock syndrome.
- Current abnormal Pap smear (women who have abnormal Paps but are ASCUS HPV negative may participate provided there is follow up for this finding per standard of care).
- Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a vaginal ring.
- Women planning to undergo major surgery.
- Breastfeeding.
- Current or past thrombophlebitis or thromboembolic disorders.
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
California Family Health Council
Los Angeles, California, 90010, United States
University of Colorado - Adv. Repro. Med.
Denver, Colorado, 80010, United States
University of Kentucky
Lexington, Kentucky, 40536-0293, United States
Contraceptive Research and Programs
Baltimore, Maryland, 21224, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
NYU Medical Center Family Planning Division
New York, New York, 10016, United States
Columbia University
New York, New York, 10032, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States
MacDonald Physicians, Inc.
Cleveland, Ohio, 44124, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health Sciences University
Portland, Oregon, 97201, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
UT Southwestern Medical Center; Division of Community Women's Health Care
Dallas, Texas, 75235, United States
Jones Institute of Repro Medicine, EVMS
Norfolk, Virginia, 23507, United States
Related Publications (4)
Plagianos MG, Ramanadhan S, Merkatz RB, Brache V, Friedland BA, Haddad LB. Risk factors for and outcomes of ring expulsions with a 1-year contraceptive vaginal system. Am J Obstet Gynecol. 2024 May;230(5):548.e1-548.e8. doi: 10.1016/j.ajog.2024.01.020. Epub 2024 Jan 29.
PMID: 38295968DERIVEDVieira CS, Fraser IS, Plagianos MG, Burke AE, Westhoff CL, Jensen J, Brache V, Bahamondes L, Merkatz R, Sitruk-Ware R, Blithe DL. Bleeding profile associated with 1-year use of the segesterone acetate/ethinyl estradiol contraceptive vaginal system: pooled analysis from Phase 3 trials. Contraception. 2019 Dec;100(6):438-444. doi: 10.1016/j.contraception.2019.07.145. Epub 2019 Aug 6.
PMID: 31398307DERIVEDArcher DF, Merkatz RB, Bahamondes L, Westhoff CL, Darney P, Apter D, Jensen JT, Brache V, Nelson AL, Banks E, Bartfai G, Portman DJ, Plagianos M, Dart C, Kumar N, Creasy GW, Sitruk-Ware R, Blithe DL. Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: results of two multicentre, open-label, single-arm, phase 3 trials. Lancet Glob Health. 2019 Aug;7(8):e1054-e1064. doi: 10.1016/S2214-109X(19)30265-7. Epub 2019 Jun 20.
PMID: 31231065DERIVEDHuang Y, Merkatz RB, Hillier SL, Roberts K, Blithe DL, Sitruk-Ware R, Creinin MD. Effects of a One Year Reusable Contraceptive Vaginal Ring on Vaginal Microflora and the Risk of Vaginal Infection: An Open-Label Prospective Evaluation. PLoS One. 2015 Aug 12;10(8):e0134460. doi: 10.1371/journal.pone.0134460. eCollection 2015.
PMID: 26267119DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kimberly Myer
- Organization
- Premier Research
Study Officials
- STUDY DIRECTOR
Diana L. Blithe, PH.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Program Director, NICHD
Study Record Dates
First Submitted
April 2, 2007
First Posted
April 3, 2007
Study Start
December 1, 2006
Primary Completion
January 1, 2009
Study Completion
September 1, 2011
Last Updated
January 23, 2026
Results First Posted
January 23, 2026
Record last verified: 2026-01