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•Kimberly Myer

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.

Eligibility

Age

18 - 39 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Women who meet all the following criteria are eligible for enrollment in the trial:
•1. Healthy women of reproductive age (18-39 years, inclusive, at the enrollment visit).
•2. Have a regular menstrual cycle that is 21-35 days in duration.
•3. Have intact uterus and both ovaries.
•4. Will be able and willing to comply with the protocol and sign an informed consent.
•5. 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).
•6. Will have diastolic blood pressure (BP) ≤85 mm Hg and systolic BP ≤135 mm Hg after 5 minutes in sitting position.
•7. Willing to abstain from use of non-water based vaginal lubricant during the study.

Exclusion Criteria

•1. 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.
•2. Not living in the catchment area of the clinic.
•3. Known hypersensitivity to progestins or estrogen.
•4. 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.
+39 more criteria

Locations (8)

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

NYU School of Medicine

New York, New York, United States

Columbia University

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

Univeristy of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

Eastern Virginia Medical School

Norfolk, Virginia, United States

Key Dates

Start Date

March 1, 2012

Primary Completion Date

May 1, 2015

Completion Date

May 1, 2015

Last Updated

December 8, 2025

Enrollment

197

ACTUAL participants

Conditions

Suppression of Ovulation

Interventions

10 µg/day E2 with NES 200® µg/day

DRUG

20 µg/day E2 with NES 200® µg/day

DRUG

40 µg/day E2 with NES 200® µg/day

DRUG