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

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

This study has been completed.

Study NCT00196326. Last updated on February 29, 2008. Information provided by Duramed Research

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

Contraception

Intervention ^†

Drug: DR-1011

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

2000

Start Date ^†

June 2005

Completion Date

June 2007

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00196326

Organization ID

DR-PSE-309

Secondary IDs ^††

Study Sponsor ^†

Duramed Research

Collaborators ^††

Investigators ^†

Study Chair:

Duramed Protocol Chair

Duramed Research, Inc.

Information Provided By

Duramed Research

Verification Date

February 2008

First Received Date ^†

September 12, 2005

Last Updated Date

February 29, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.