A Phase 2, Randomized Study to Evaluate the Safety and Efficacy of Two Contraceptive Vaginal Rings Delivering a Daily Dose of 1500 or 2500 μg of CDB-2914 on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling Women

Population Council3 sites in 3 countries55 target enrollmentOctober 2008

ConditionsContraception

InterventionsCDB-2914

DrugsCDB-2914

Overview

Phase: Phase 2
Intervention: CDB-2914
Conditions: Contraception
Sponsor: Population Council
Enrollment: 55
Locations: 3
Primary Endpoint: The primary efficacy variable will be ovulation suppression measured by progesterone serum levels.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to to determine pharmacodynamic effects of a vaginal ring delivering either 1,500 or 2,500 μg of CDB-2914 per day during 6 months of treatment on:

follicular function and inhibition of ovulation
the endometrium
bleeding patterns; and also to assess safety including effects on the endometrium

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

September 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Population Council

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy women of reproductive age (21-40 years)
•Not at risk for pregnancy based on one of the following
•subject has undergone sterilization
•subject is monogamous and her male partner has undergone sterilization
•subject agrees to be abstinent for the entire duration of the study (Oregon site only)
•subject does not have sex with men (Oregon site only)
•Have regular menstrual cycles of 25-35 days duration
•Have an intact uterus and both ovaries
•Will be able to comply with the protocol
•Capable of giving informed consent

Exclusion Criteria

•Women participating in another clinical trial
•Women not living in the catchment area of the clinic
•Known hypersensitivity to progestins or antiprogestins
•Known hypersensitivity to silicone rubber
•Any chronic disease
•All contraindications to oral contraceptive use, including
•Thrombophlebitis or thromboembolic disorders
•Past history of deep vein thrombophlebitis or thromboembolic disorders
•Past or current cerebrovascular or coronary artery disease
•Migraine with focal aura

Arms & Interventions

1

Contraceptive Vaginal Ring delivering a daily dose of 1500 μg of CDB-2914

Intervention: CDB-2914

2

Contraceptive Vaginal Ring delivering a daily dose of 2500 μg of CDB-2914

Intervention: CDB-2914

Outcomes

Primary Outcomes

The primary efficacy variable will be ovulation suppression measured by progesterone serum levels.

Time Frame: All women will use the assigned CVR for 6 months

Secondary Outcomes

Clinical safety will be evaluated and the effects on the endometrium will be measured.(All women will use the assigned CVR for 6 months)
Regular follow-up of follicle diameter will be made with USS to determine the timing of ovulation or, in the absence of ovulation, the fate of the dominant follicle.(All women will use the assigned CVR for 6 months)