Loading clinical trials...

COMPLETEDPHASE3

Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive

A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose, Combination Oral Contraceptive, Which Utilizes Ethinyl Estradiol During the Seven Day Interval Between Each 84-day Cycle

NCT00196326•Duramed Research

View on ClinicalTrials.gov

Summary

This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. 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

•Premenopausal
•Not pregnant or breastfeeding
•Sexually active at risk of pregnancy

Exclusion Criteria

•Any contraindication to the use of oral contraceptives
•Pregnancy within the last 3 months
•Smoking \> 10 cigarettes per day

Locations (55)

Duramed Investigational Site

Huntsville, Alabama, United States

Duramed Investigational Site

Phoenix, Arizona, United States

Duramed Investigational Site

Phoenix, Arizona, United States

Duramed Investigational Site

Phoenix, Arizona, United States

Duramed Investigational Site

Tucson, Arizona, United States

Duramed Investigational Site

San Diego, California, United States

Duramed Investigational Site

San Diego, California, United States

Duramed Investigational Site

Colorado Springs, Colorado, United States

Duramed Investigational Site

Colorado Springs, Colorado, United States

Duramed Investigational Site

Denver, Colorado, United States

Key Dates

Start Date

June 1, 2005

Primary Completion Date

June 1, 2007

Completion Date

June 1, 2007

Last Updated

November 16, 2016

Enrollment

2,235

ACTUAL participants

Conditions

Contraception

Interventions

DR-1011

DRUG

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

NCT06345586

Contraception

View study

RECRUITINGNA

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

NCT07115849

EumenorrheaIntrauterine Devices, Medicated+1 more

View study

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 16, 2016Data 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

Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive

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