Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring

NCT03432416 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: CCN012B
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 11

Brief Summary

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).

Conditions

Healthy Women; Female Contraception

Keywords

Healthy Women; Female Contraception; Vaginal Ring; Contraceptive Vaginal Ring

Outcome Measures

Primary Outcomes (1)

• Pregnancy Rate

  1 year

Secondary Outcomes (27)

• Change in subjects' bleeding patterns for continuous vs cyclic use as compared to reported baseline bleeding patterns when the subjects were not on hormonal contraception using a bleeding questionnaire.

  1 year

• Difference in bleeding patterns for continuous vs cyclic use using a bleeding diary.

  1 year

• Incidence of adverse events, including serious adverse events

  1 year

• Summary of number of bleeding and spotting days per 30- and 90- day intervals using a bleeding diary.

  Every 30 and 90 days up to a total of 1 year

• Summary of cyclic versus continuous use adverse events.

  1 year

Study Arms (2)

Regimen 1: Continuous Usage

EXPERIMENTAL

Contraceptive vaginal ring delivering a daily dose of Nestorone® and estradiol (NES-E2 CVR) worn continuously for 91 days.

Drug: NES-E2 CVR

Regimen 2: Cyclical Usage

EXPERIMENTAL

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).

Drug: NES-E2 CVR

Interventions

NES-E2 CVR DRUG

NES-E2 CVR

Regimen 1: Continuous Usage; Regimen 2: Cyclical Usage

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good general overall health with no chronic medical conditions that result in periodic exacerbations requiring significant medical care.
• Age 18-35 years, inclusive, at the enrollment visit. (Note: subjects must be at least 18 years of age to provide consent.)
• Have a regular menstrual cycle 21-35 days in duration when not using hormonal contraception
• Have an intact uterus and at least one ovary.
• 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.)
• 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.
• Have a negative pregnancy test at the enrollment visit.
• 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.
• Understand and sign an IRB-approved informed consent form prior to screening activities (including fasting blood draws).
• BMI ≤ 35 kg/m2 and not having previously undergone bariatric surgery.
• 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.

You may not qualify if:

• Planning pregnancy during study participation through the end of treatment visit.
• Within 30 days post-partum, currently breast-feeding, or has not had a spontaneous menses.
• Post-abortal and has not had a spontaneous menses.
• Abnormal genital bleeding.
• 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.
• Not living in the catchment area of the study site.
• Known hypersensitivity to progestins or estrogens.
• Contraindications to combined estrogen-progestin contraceptive use including:
• Thrombophlebitis or thromboembolic disorders.
• Personal history of deep vein thrombophlebitis or thromboembolic disorders.
• History of venous thrombosis or embolism in a first-degree relative \<55 years of age suggesting a familial defect in the blood coagulation system.
• History of thrombosis or embolism OR any other personal or family history which in the opinion of the investigator suggests increased risk.
• History of stroke.
• Known history of any of the following genetic mutations: Factor V Leiden mutation, prothrombin mutation, antithrombin deficiency, or other clinically significant thrombophilia.
• Known or suspected carcinoma of the breast.

Sponsors & Collaborators

• Premier Research: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Population Council: collaborator

Study Sites (11)

Essential Access Health

Los Angeles, California, 30010, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Bellevue Hospital Center

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Oregon Health Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (32)

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Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: February 14, 2018
• Study Start: February 12, 2018
• Primary Completion: August 28, 2021
• Study Completion: December 14, 2021
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)