Loading clinical trials...

A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy

A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen (DR-103) for the Prevention of Pregnancy in Women

NCT00996580•Teva Women's Health

View on ClinicalTrials.gov

Summary

This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Eligibility

Age

18 - 40 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Sexually active at risk for pregnancy
•Agreement to use study OC therapy as their only method of birth control during the study
•history of regular spontaneous menstrual cycles or withdrawal bleeding episodes
•Others as dictated by FDA-approved protocol

Exclusion Criteria

•Any contraindication to the use of oral contraceptives
•Pregnancy or plans to become pregnant in the next 14 months
•Smoker and age ≥ 35 years
•Others as dictated by FDA-approved protocol

Locations (94)

Teva Women's Health Research Investigational Site

Montgomery, Alabama, United States

Teva Women's Health Research Investigational Site

Phoenix, Arizona, United States

Teva Women's Health Research Investigational Site

Phoenix, Arizona, United States

Teva Women's Health Research Investigational Site

Tucson, Arizona, United States

Teva Women's Health Research Investigational Site

Little Rock, Arkansas, United States

Teva Women's Health Research Investigational Site

Anaheim, California, United States

Teva Women's Health Research Investigational Site

Irvine, California, United States

Teva Women's Health Research Investigational Site

Los Angeles, California, United States

Teva Women's Health Research Investigational Site

National City, California, United States

Teva Women's Health Research Investigational Site

San Diego, California, United States

Key Dates

Start Date

October 1, 2009

Primary Completion Date

September 1, 2011

Completion Date

September 1, 2011

Last Updated

June 24, 2013

Enrollment

3,597

ACTUAL participants

Conditions

Pregnancy Prevention

Interventions

DR-103

DRUG

Sponsors

Lead Sponsor

Teva Women's Health

Related Studies

NOT_YET_RECRUITINGNA

Telemedicine for Contraceptive Counselling- An Open Randomized Controlled Trial

NCT06896539

Unintended Pregnancy Prevention

Evaluating the Impact of Online Educator Microskill Training on Educator Knowledge and Skill

NCT05950828

HIV/AIDS PreventionSTI Prevention+1 more

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions