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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:
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 
Overall Participants Analyzed 
[Units: Participants]
 1683 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 28.6  (6.9) 
[1] MITT (Modified Intent to Treat) Population
Age, Customized [1] 
[Units: Participants]
 
18-35 years   1295 
>35 years   287 
[1] MITT Population
Gender [1] 
[Units: Participants]
 
Female   1582 
Male   0 
[1] MITT Population
Region of Enrollment [1] 
[Units: Participants]
 
United States   1582 
[1] MITT Population


  Outcome Measures
  Show All Outcome Measures

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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