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

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

	DR-1011
STARTED	2185^[1]
COMPLETED	1249
NOT COMPLETED	936

[1]	Took at least one dose of study medication

Baseline Characteristics

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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

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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) ]

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2. Secondary:

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

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Measure Type	Secondary
Measure Title	Adverse Events Reported by Patients and Investigators
Measure Description	Safety was assessed by summarizing adverse events recorded in the patient's daily diary and reported by subjects at each study visit, and by summarizing results of examinationa, vital signs and clinical laboratory values.
Time Frame	Up to one year
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety cohort consisted of all patient who took at least one dose of study medication

Reporting Groups

	Description
DR-1011	Investigational Drug: Take 1 tablet daily

Measured Values

	DR-1011
Number of Participants Analyzed [units: participants]	2185
Adverse Events Reported by Patients and Investigators [units: Participants]	1742

No statistical analysis provided for Adverse Events Reported by Patients and Investigators

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The sponsor can (i) review results communications prior to public release and can embargo communications regarding trial results for a period of at least 60 days but no more than 180 days from the time submitted to the sponsor for review; and (ii) require in instances of a multi-center study, that a single PI not disclose study data until after the multi-center results are published, provided such results are published within eighteen (18) months of the conclusion of the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Duramed Research Protocol Chair
Organization: Duramed Research
phone: 215-293-7279
e-mail: medicalaffairs@barrlabs.com

No publications provided

Responsible Party:	Duramed Research, Inc. ( Druamed Protocol Chair )
Study ID Numbers:	DR-PSE-309
Study First Received:	September 12, 2005
Results First Received:	November 21, 2008
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00196326 History of Changes
Health Authority:	United States: Food and Drug Administration