Study to Evaluate the Safety and Efficacy of Two Contraceptive Vaginal Rings Delivering a Daily Dose of 1500 or 2500 μg of CDB-2914

NCT00791297 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2017-08-15

No results posted yet for this study

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:

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

Conditions

  • Contraception

Interventions

DRUG

CDB-2914

Contraceptive Vaginal Rings delivering a daily dose of 1500 or 2500 μg of CDB-2914

Sponsors & Collaborators

  • Population Council

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States
  • Chile
  • Dominican Republic

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00791297 on ClinicalTrials.gov