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:
NCT00391807
First received: October 20, 2006
Last updated: April 15, 2013
Last verified: April 2013
Results First Received: November 23, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Contraception
Intervention: Drug: Norethindrone acetate/ethinyl estradiol

  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
Recruitment period 01 Nov '06 thru 24 Aug '08

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Norethindrone/Ethinyl Estradiol 1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days

Participant Flow:   Overall Study
    Norethindrone/Ethinyl Estradiol  
STARTED     1683  
COMPLETED     968  
NOT COMPLETED     715  
Did not receive study medication                 23  
Adverse Event                 177  
Pregnancy                 25  
Lost to Follow-up                 227  
Withdrawal by Subject                 147  
Protocol Violation                 20  
Various                 96  



  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
Norethindrone/Ethinyl Estradiol 1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days

Baseline Measures
    Norethindrone/Ethinyl Estradiol  
Number of Participants  
[units: participants]
  1683  
Age [1]
[units: years]
Mean ± Standard Deviation
  28.6  ± 6.9  
Age, Customized [2]
[units: participants]
 
18-35 years     1295  
>35 years     287  
Gender [2]
[units: participants]
 
Female     1582  
Male     0  
Region of Enrollment [2]
[units: participants]
 
United States     1582  
[1] MITT (Modified Intent to Treat) Population
[2] MITT Population



  Outcome Measures
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1.  Primary:   Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,   [ Time Frame: 13 cycles, 28 days each (1 year) ]

2.  Primary:   Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population   [ Time Frame: 13 Cycles, 28 days each (1 year) ]

3.  Secondary:   Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population   [ Time Frame: 2 Cycles, 28 days each (56 days) ]

4.  Secondary:   Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population   [ Time Frame: 6 cycles, 28 days each (168 days) ]

5.  Secondary:   Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population   [ Time Frame: 13 cycles, 28 days each (1 year) ]

6.  Secondary:   Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population   [ Time Frame: 2 cycles, 28 days each (56 days) ]

7.  Secondary:   Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population   [ Time Frame: 6 cycles, 28 days each (168 days) ]

8.  Secondary:   Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population   [ Time Frame: 13 cycles, 28 days each (1 year) ]

9.  Secondary:   Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population   [ Time Frame: 2 cycles, 28 days each (56 days) ]

10.  Secondary:   Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population   [ Time Frame: 6 cycles, 28 days each (168 days) ]

11.  Secondary:   Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population   [ Time Frame: 12 cycles, 28 days each (336 days) ]

12.  Secondary:   Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population   [ Time Frame: 2 cycles, 28 days each (56 days) ]

13.  Secondary:   Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population   [ Time Frame: 6 cycles, 28 days each (168 days) ]

14.  Secondary:   Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population   [ Time Frame: 13 cycles, 28 days each (1 year) ]

15.  Secondary:   Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population   [ Time Frame: 2 cycles, 28 days each (56 days) ]

16.  Secondary:   Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population   [ Time Frame: 6 cycles, 28 days each (168 days) ]

17.  Secondary:   Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population   [ Time Frame: 13 cycles, 28 days each (1 year) ]


  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
No text entered.


  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 by Warner Chilcott

Publications automatically indexed to this study:

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00391807     History of Changes
Other Study ID Numbers: PR-05806
Study First Received: October 20, 2006
Results First Received: November 23, 2010
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration