Study of Safety and Efficacy of an Oral Contraceptive

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Warner Chilcott

ClinicalTrials.gov Identifier:

NCT00932321

First received: June 30, 2009

Last updated: April 15, 2013

Last verified: April 2013

History of Changes

Results First Received: February 22, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Prevention of Pregnancy
Interventions:	Drug: Norethindrone Acetate/Ethinyl Estradiol 24 Days Drug: Norethindrone Acetate /Ethinyl Estradiol 21 Days

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
32 investigational study sites recruited 938 women aged 18 - 45 years of age beginning Feb '04

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
MITT Population defined as subset of All Treated Subjects who were evaluated for pregnancy, either positive or negative, at least once after beginning the study medication. Completed subjects - subset of MITT subjects completing at least 161 days of treatment based on returned drug or diary.

Reporting Groups

	Description
24 Day NA/EE	Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
21 Day NA/EE	Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets

Participant Flow: Overall Study

	24 Day NA/EE	21 Day NA/EE
STARTED	751	187
MITT Population	705	181
COMPLETED	580	141
NOT COMPLETED	171	46

Baseline Characteristics

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Reporting Groups

	Description
24 Day NA/EE	Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
21 Day NA/EE	Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
Total	Total of all reporting groups

Baseline Measures

	24 Day NA/EE	21 Day NA/EE	Total
Number of Participants [units: participants]	751	187	938
Age, Customized ^[1] [units: Participants]
Age, Unknown	1	1	2
18-35 years	579	151	730
> 35 years	125	29	154
Gender [units: participants]
Female	751	187	938
Male	0	0	0
Region of Enrollment [units: participants]
United States	751	187	938

[1]	MITT (Modified Intent to Treat) Population

Outcome Measures

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1. Primary:

Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population [ Time Frame: 5.6 months (6 - 28 day cycles) ]

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2. Secondary:

Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population [ Time Frame: 5.6 months (6 - 28 day cycles) ]

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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.

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: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
phone: 973-442-3376
e-mail: gwulff@wcrx.com

No publications provided

Responsible Party:	Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00932321 History of Changes
Other Study ID Numbers:	PR-03903
Study First Received:	June 30, 2009
Results First Received:	February 22, 2011
Last Updated:	April 15, 2013
Health Authority:	United States: Food and Drug Administration

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