Oral Contraceptive Pills Compared to Vaginal Rings

This study has been completed.

Sponsors and Collaborators:	University of California, San Francisco Organon
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00357526

Purpose

The purpose of this study is to determine whether teens and young women would prefer the Nuvaring to oral contraceptive pills after having tried both methods.

Condition	Intervention
Pregnancy	Drug: OCPs Device: vaginal ring

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment
Official Title:	YOUNG WOMEN’S EXPERIENCES: ORAL CONTRACEPTIVE PILLS VS The VAGINAL RING

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Satisfaction

Secondary Outcome Measures:

Compliance
Acceptability

Estimated Enrollment:	130
Study Start Date:	April 2003
Estimated Study Completion Date:	August 2004

Detailed Description:

Sexually active young women (n=130), aged 15-21 years, were randomly assigned to use either the vaginal ring or oral contraceptive pills for an initial study interval of three 28-day cycles, followed by three cycles of the alternate method. Participants completed surveys about method use, acceptability and side effects at baseline, after three cycles, and after six cycles, as well as in a follow up telephone interview one month after study completion.

Eligibility

Ages Eligible for Study:	15 Years to 21 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Sexually active young women (n=130), English or Spanish speaking, aged 15-21 years, able and willing to try oral contraceptives and vaginal rings for 6 months

Exclusion Criteria:

Not able or willing to use hormonal contraceptives, moving out of the area, pregnant or intending to become pregnant during the study time frame, not sexually active

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357526

Locations

United States, California
New Generation Health Center
San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

Organon

Investigators

Principal Investigator:

Felicia Stewart, MD

University of California, San Francisco

More Information

Study ID Numbers:	H10857-19674-04
Study First Received:	July 25, 2006
Last Updated:	April 19, 2007
ClinicalTrials.gov Identifier:	NCT00357526
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

vaginal ring
Oral contraceptive pills
Teenagers
Young women
Patient satisfaction

ClinicalTrials.gov processed this record on January 16, 2009