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 Information provided by Duramed Research

First Received: September 12, 2005 Last Updated: July 23, 2009 History of Changes

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Condition:	Contraception
Intervention:	Drug: DR-1011

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
DR-1011	Investigational Drug: Take 1 tablet daily

Participant Flow: Overall Study

[1]	Took at least one dose of study medication

Baseline Characteristics

Reporting Groups

	Description
DR-1011	Investigational Drug: Take 1 tablet daily

Baseline Measures

	DR-1011
Number of Participants [units: participants]	2185
Age [units: years] Mean ± Standard Deviation	27.7 ± 5.80
Gender [units: participants]
Female	2185
Male	0
Region of Enrollment [units: participants]
United States	2185

Outcome Measures

1. Primary:

Pregnancy Rate (Pearl Index) [ After the onset of treatment and within 14 days after the last combination pill (approx. 1 year of treatment) ]

Show Outcome Measure 1

2. Secondary:

Adverse Events Reported by Patients and Investigators [ Up to one year ]

Show Outcome Measure 2