A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone® and Estradiol, on Cycle Control, Ovulation Inhibition, and Pharmacokinetics in Normal Cycling Women

NCT01586000 | Completed Phase 2 Results

• 1 other identifier: CCN012
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 8

Brief Summary

This clinical trial is an experimental research study using a potential new form of birth control. Clinical trials include people who volunteer to take part in a study. Take your time to decide if you want to be part of this experimental research study. If you want to know more about this study first, ask the study doctor or study site staff. The investigators can also give you the study information written for doctors and clinic staff.

Conditions

Suppression of Ovulation

Keywords

vaginal ring

Outcome Measures

Primary Outcomes (1)

• Number of Days Bleeding is Reported.

  The primary outcome will be the number of days that bleeding or spotting is reported in the first 3 cycles (90 days) of treatment.

  Three months

Secondary Outcomes (31)

• Number of Subjects With Ovulation at During Each Cycle

  Control Cycle 1, Treatment Cycles 2, 3, and 7, Recovery Cycle 8, up to 8 months

• Area Under the Curve of NES and E2 at Specified Time Points

  Visits 12, 32, and 41 (Treatment Period)

• The Safety of Administering 200 µg/Day of NES and One of Three Doses (10, 20, or 40 µg/Day) of E2 Delivered by CVR Continuously for 6 Months (180 Days).

  Through Recovery Cycle 8, up to 8 months

• Number of Days Bleeding is Reported.

  Three months

• Changes From Baseline in Albumin (g/dL)

  Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening)

Study Arms (3)

10 µg/day E2

EXPERIMENTAL

Two consecutive 3-month (90-day) rings will be used continuously for six months (180 days).

Drug: 10 µg/day E2 with NES 200® µg/day

20 µg/day E2

EXPERIMENTAL

Two consecutive 3-month (90-day) rings will be used continuously for six months (180 days).

Drug: 20 µg/day E2 with NES 200® µg/day

40 µg/day E2

EXPERIMENTAL

Two consecutive 3-month (90-day) rings will be used continuously for six months (180 days).

Drug: 40 µg/day E2 with NES 200® µg/day

Interventions

10 µg/day E2 with NES 200® µg/day DRUG

10 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)

10 µg/day E2

20 µg/day E2 with NES 200® µg/day DRUG

20 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)

20 µg/day E2

40 µg/day E2 with NES 200® µg/day DRUG

40 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)

40 µg/day E2

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women who meet all the following criteria are eligible for enrollment in the trial:
• Healthy women of reproductive age (18-39 years, inclusive, at the enrollment visit).
• Have a regular menstrual cycle that is 21-35 days in duration.
• Have intact uterus and both ovaries.
• Will be able and willing to comply with the protocol and sign an informed consent.
• Will not be at risk for pregnancy. They will be consistently using a non-hormonal method, have a surgically sterile male partner with a vasectomy, be abstinent, or be in a same-sex relationship from the control period through study exit (including recovery period).
• Will have diastolic blood pressure (BP) ≤85 mm Hg and systolic BP ≤135 mm Hg after 5 minutes in sitting position.
• Willing to abstain from use of non-water based vaginal lubricant during the study.

You may not qualify if:

• Women who meet any of the following criteria are not eligible for enrollment in the trial:
• 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 clinic.
• Known hypersensitivity to progestins or estrogen.
• All contraindications to combined estrogen-progestin contraceptive use including:
• Thrombophlebitis or thromboembolic disorders.
• Past 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 familial defect in blood coagulation system, which in the opinion of the investigator, suggests use of a hormonal contraceptive could pose a significant risk.
• History of stroke.
• Known or suspected carcinoma of the breast.
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
• Undiagnosed abnormal genital bleeding.
• Cholestatic jaundice of pregnancy or jaundice with prior oral contraceptive use.
• Hepatic adenomas or carcinomas.
• Known or suspected pregnancy.

Sponsors & Collaborators

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

Study Sites (8)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21224, United States

Location

NYU School of Medicine

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

Univeristy of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Results Point of Contact

• Title: Kimberly Myer, Sr. Program Director, NIH
• Organization: Premier Research

Kimberly.Myer@premier-research.com

984-238-1297

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Program Director

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: April 26, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 8, 2025
• Results First Posted: December 8, 2025

Record last verified: 2022-06

Locations

US (8)