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Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00274261
First received: January 6, 2006
Last updated: April 30, 2013
Last verified: November 2012
Results First Received: December 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Pregnancy
Interventions: Drug: C31G
Drug: nonoxynol-9 (N-9)

  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
Female subjects were screened and enrolled at 15 sites in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None.

Reporting Groups
  Description
C31G C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
Conceptrol Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.

Participant Flow:   Overall Study
    C31G     Conceptrol  
STARTED     932     633  
COMPLETED     443     296  
NOT COMPLETED     489     337  
Adverse Event                 19                 11  
Pregnancy                 114                 83  
Withdrawal by Subject                 179                 126  
Protocol Violation                 71                 42  
Lost to Follow-up                 106                 75  



  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
C31G C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
Conceptrol Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
Total Total of all reporting groups

Baseline Measures
    C31G     Conceptrol     Total  
Number of Participants  
[units: participants]
  932     633     1565  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     932     633     1565  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  28.1  ± 5.58     28.3  ± 5.90     28.2  ± 5.71  
Gender  
[units: participants]
     
Female     932     633     1565  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     932     633     1565  



  Outcome Measures

1.  Primary:   The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.   [ Time Frame: 6 months ]

2.  Secondary:   Incidence of Adverse Events.   [ Time Frame: The DSMB will review safety data at 3 months following 200 subjects enrolled, 3 months following 400 subject enrolled, as well as additional meetings as needed. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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
None.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Jason Woo, MD, MPH
Organization: NICHD
phone: 301-496-1662
e-mail: woojj@mail.nih.gov


No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications automatically indexed to this study:

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00274261     History of Changes
Other Study ID Numbers: HHSN27500002, HHSN2752004033661
Study First Received: January 6, 2006
Results First Received: December 14, 2012
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration