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A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy

A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of a Combination Oral Contraceptive Regimen (DR-102) for the Prevention of Pregnancy in Women

NCT01178125•Teva Branded Pharmaceutical Products R&D, Inc.

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-102. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a daily diary.

Eligibility

Age

18 - 40 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Sexually active at risk for pregnancy
•Agreement to use study oral contraceptive 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 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 greater than or equal to 35 years
•Others as dictated by protocol

Locations (62)

Teva Investigational Site 10007

Montgomery, Alabama, United States

Teva Investigational Site 10013

Phoenix, Arizona, United States

Teva Investigational Site 10017

Phoenix, Arizona, United States

Teva Investigational Site 10032

Little Rock, Arkansas, United States

Teva Investigational Site 10026

San Diego, California, United States

Teva Investigational Site 10056

San Diego, California, United States

Teva Investigational Site 10002

Colorado Springs, Colorado, United States

Teva Investigational Site 10033

Colorado Springs, Colorado, United States

Teva Investigational Site 10057

Washington D.C., District of Columbia, United States

Teva Investigational Site 10052

Clearwater, Florida, United States

Key Dates

Start Date

August 1, 2010

Primary Completion Date

January 1, 2013

Completion Date

January 1, 2013

Last Updated

November 9, 2021

Enrollment

2,858

ACTUAL participants

Conditions

ContraceptionFemale Contraception

Interventions

DR-102

DRUG

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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: November 9, 2021Data 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.

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A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy

Inclusion Criteria

Exclusion Criteria

Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study

Effect of Different Sex Hormone Profiles for the Response to Physical Training

Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing Potential

Investigating Ovulation Inhibition for Use as a Contraceptive

Improving Shared Decision-Making in Menstrual Management and Contraception for Adolescents and Young Adults

Oral Contraceptive Pill (OCP) Pharmacogenomics