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A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods

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ClinicalTrials.gov Identifier: NCT00253019
Recruitment Status : Completed
First Posted : November 15, 2005
Results First Posted : August 9, 2013
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):
Carrie Cwiak, Emory University

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Contraception
Enrollment 321
Recruitment Details Participants were recruited from a medical clinic beginning in 10/2004 through 11/2005.
Pre-assignment Details All patients were invited to participate.
Arm/Group Title Oral Contraceptive Depo Provera Ortho Evra
Hide Arm/Group Description Participants self-selected to receive oral contraceptives. Participants self-selected to receive Depo Provera Participants self-selected to receive Ortho Evra.
Period Title: Overall Study
Started 111 109 101
Completed 82 78 83
Not Completed 29 31 18
Arm/Group Title Oral Contraceptive Depo Provera Ortho Evra Total
Hide Arm/Group Description Participants self-selected to receive oral contraceptives. Participants self-selected to receive Depo Provera Participants self-selected to receive Ortho Evra. Total of all reporting groups
Overall Number of Baseline Participants 111 109 101 321
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 109 participants 101 participants 321 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
111
 100.0%
109
 100.0%
101
 100.0%
321
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 109 participants 101 participants 321 participants
Female
111
 100.0%
109
 100.0%
101
 100.0%
321
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
The measure is of what contraceptive method the participants chose to use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 111 participants 109 participants 101 participants 321 participants
<=18 years 0 0 0 0
Between 18 and 65 years 111 109 101 321
>=65 years 0 0 0 0
1.Primary Outcome
Title Continuation Rates
Hide Description We followed subjects to evaluate the continuation rates for subjects receiving oral contraceptive pills, Depo Provera and Ortho Evra.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
It was a convenience sample.
Arm/Group Title Oral Contraceptive Depo Provera Ortho Evra
Hide Arm/Group Description:
Participants self-selected to receive oral contraceptives.
Participants self-selected to receive Depo Provera
Participants self-selected to receive Ortho Evra.
Overall Number of Participants Analyzed 111 109 101
Measure Type: Number
Unit of Measure: participants
82 78 83
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Contraceptives Depo Provera Ortho Evra
Hide Arm/Group Description participants self-selected to take oral contraceptives Participants self-selected to use depo provera participants self-selected to receive ortho evra
All-Cause Mortality
Oral Contraceptives Depo Provera Ortho Evra
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oral Contraceptives Depo Provera Ortho Evra
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/111 (0.00%)   0/109 (0.00%)   0/101 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oral Contraceptives Depo Provera Ortho Evra
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/111 (0.00%)   0/109 (0.00%)   0/101 (0.00%) 
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
Responsible Party: Carrie Cwiak, Emory University
ClinicalTrials.gov Identifier: NCT00253019     History of Changes
Other Study ID Numbers: 518-2003
First Submitted: November 14, 2005
First Posted: November 15, 2005
Results First Submitted: April 9, 2013
Results First Posted: August 9, 2013
Last Update Posted: August 21, 2013