Trial Outcomes & Findings for A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods (NCT NCT00253019)

NCT ID: NCT00253019

Last Updated: 2013-08-21

Results Overview

We followed subjects to evaluate the continuation rates for subjects receiving oral contraceptive pills, Depo Provera and Ortho Evra.

• Recruitment status: COMPLETED
• Target enrollment: 321 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2013-08-21

Participant Flow

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

All patients were invited to participate.

Participant milestones

Measure	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.
Overall Study STARTED	111	109	101
Overall Study COMPLETED	82	78	83
Overall Study NOT COMPLETED	29	31	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods

Baseline characteristics by cohort

Measure	Oral Contraceptive n=111 Participants Participants self-selected to receive oral contraceptives.	Depo Provera n=109 Participants Participants self-selected to receive Depo Provera	Ortho Evra n=101 Participants Participants self-selected to receive Ortho Evra.	Total n=321 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	111 Participants n=5 Participants	109 Participants n=7 Participants	101 Participants n=5 Participants	321 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	111 Participants n=5 Participants	109 Participants n=7 Participants	101 Participants n=5 Participants	321 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
The measure is of what contraceptive method the participants chose to use <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
The measure is of what contraceptive method the participants chose to use Between 18 and 65 years	111 participants n=5 Participants	109 participants n=7 Participants	101 participants n=5 Participants	321 participants n=4 Participants
The measure is of what contraceptive method the participants chose to use >=65 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants

PRIMARY outcome

Timeframe: 3 months

Population: It was a convenience sample.

We followed subjects to evaluate the continuation rates for subjects receiving oral contraceptive pills, Depo Provera and Ortho Evra.

Outcome measures

Measure	Oral Contraceptive n=111 Participants Participants self-selected to receive oral contraceptives.	Depo Provera n=109 Participants Participants self-selected to receive Depo Provera	Ortho Evra n=101 Participants Participants self-selected to receive Ortho Evra.
Continuation Rates	82 participants	78 participants	83 participants

Adverse Events

Oral Contraceptives

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Depo Provera

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ortho Evra

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carrie Cwiak, MD, MPH

Emory University

Phone: 404-778-1696

Email: ccwiak@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place