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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
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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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.
No text entered.

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) ]

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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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