Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive - Tabular View

Tracking Information

First Received Date ^ICMJE

August 9, 2006

Last Updated Date

July 23, 2009

Start Date ^ICMJE

August 2006

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluation of pregnancy rates [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Evaluation of pregnancy rates

Change History

Complete list of historical versions of study NCT00362479 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse events reported by patients and investigators [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Adverse events reported by patients and investigators

Descriptive Information

Brief Title ^ICMJE

Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive

Official Title ^ICMJE

A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021

Brief Summary

This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Detailed Description

The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study drug.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Contraception

Intervention ^ICMJE

Drug: DR-1021

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1347

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00362479

Responsible Party

Duramed Protocol Chair, Duramed Research, Inc.

Study ID Numbers ^ICMJE

DR-DSG-301

Study Sponsor ^ICMJE

Duramed Research

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Duramed Medical Monitor

Duramed Research

Information Provided By

Duramed Research

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP