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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

July 23, 2009

Start Date ^ICMJE

June 2005

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Pregnancy Rate (Pearl Index) [ Time Frame: After the onset of treatment and within 14 days after the last combination pill (approx. 1 year of treatment) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Evaluation of pregnancy rates

Change History

Complete list of historical versions of study NCT00196326 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse Events Reported by Patients and Investigators [ Time Frame: Up to one year ] [ 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 Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive

Official Title ^ICMJE

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

Brief 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.

Detailed Description

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-1011

Study Arms / Comparison Groups

Experimental: Investigational Drug

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

2235

Completion Date

June 2007

Primary Completion Date

June 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 40 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

NCT00196326

Responsible Party

Druamed Protocol Chair, Duramed Research, Inc.

Study ID Numbers ^ICMJE

DR-PSE-309

Study Sponsor ^ICMJE

Duramed Research

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Duramed Protocol Chair

Duramed Research, Inc.

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