A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carrie Cwiak, Emory University
ClinicalTrials.gov Identifier:
NCT00253019
First received: November 14, 2005
Last updated: August 10, 2013
Last verified: August 2013
Results First Received: April 9, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Contraception

  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
Participants were recruited from a medical clinic beginning in 10/2004 through 11/2005.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients were invited to participate.

Reporting Groups
  Description
Oral Contraceptive Participants self-selected to receive oral contraceptives.
Depo Provera Participants self-selected to receive Depo Provera
Ortho Evra Participants self-selected to receive Ortho Evra.

Participant Flow:   Overall Study
    Oral Contraceptive     Depo Provera     Ortho Evra  
STARTED     111     109     101  
COMPLETED     82     78     83  
NOT COMPLETED     29     31     18  



  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
Oral Contraceptive Participants self-selected to receive oral contraceptives.
Depo Provera Participants self-selected to receive Depo Provera
Ortho Evra Participants self-selected to receive Ortho Evra.
Total Total of all reporting groups

Baseline Measures
    Oral Contraceptive     Depo Provera     Ortho Evra     Total  
Number of Participants  
[units: participants]
  111     109     101     321  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     111     109     101     321  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     111     109     101     321  
Male     0     0     0     0  
The measure is of what contraceptive method the participants chose to use  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     111     109     101     321  
>=65 years     0     0     0     0  



  Outcome Measures

1.  Primary:   Continuation Rates   [ Time Frame: 3 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Carrie Cwiak, MD, MPH
Organization: Emory University
phone: 404-778-1696
e-mail: ccwiak@emory.edu


No publications provided


Responsible Party: Carrie Cwiak, Emory University
ClinicalTrials.gov Identifier: NCT00253019     History of Changes
Other Study ID Numbers: 518-2003
Study First Received: November 14, 2005
Results First Received: April 9, 2013
Last Updated: August 10, 2013
Health Authority: United States: Institutional Review Board