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Combined Hormonal Contraceptive Use in High Risk Women: A Longitudinal Study

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ClinicalTrials.gov Identifier: NCT00361400
Recruitment Status : Completed
First Posted : August 8, 2006
Last Update Posted : August 2, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is an examination of "high risk" young women, 15-24 years of age, who initiate first time use of vaginal ring, oral contraceptives, contraceptive path, or Depo-provera.

Condition or disease

Detailed Description:
Approximately 1600 young women will be enrolled in a 12 month, observation study of their contraceptive use. They will complete surveys at baseline, 3, 6 and 12 months. They will also undergo pregnancy testing at baseline, 6 and 12 month visits. The study is examining such things are the relationship between partnerships, parental and peer influences, and contraceptive choice; Factors associated with long term continuation of contraceptive methods; Attributes of new hormonal contraceptive associated with user satisfaction and long-term continuation; And the extent to which high-risk women who use these methods are also condom users and determine the characteristics of these users.

Study Design

Study Type : Observational
Actual Enrollment : 1387 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Combined Hormonal Contraceptive Use in High Risk Women: A Longitudinal Study
Study Start Date : August 2005
Primary Completion Date : September 2008
Study Completion Date : September 2008
Groups and Cohorts

Outcome Measures

Biospecimen Retention:   Samples Without DNA
urine for pregnancy testing

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Planned Parenthood patients who present to start a hormonal birth control for the first time.

Inclusion Criteria:

- 15-24 years old, English or spanish speaking, Starting ring, pill, patch, or Depo for first time, Sexually active, Single, Not pregnant, Living in Bay Area for next 12 months

Exclusion Criteria:

Past user of method, Married, Pregnant, Moving out of area, Not sexually active

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361400

United States, California
Planned Parenthood-Golden Gate
Hayward, California, United States, 94541
Planned Parenthood-Golden Gate
Oakland, California, United States, 94605
Planned Parenthood - Shasta Diablo
Richmond, California, United States, 94806
University of California, San Francisco
San Francisco, California, United States, 94110
Planned Parenthood - Shasta Diablo
Vallejo, California, United States, 94590
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
Principal Investigator: Tina R Raine, MD, MPH University of California, San Francisco
Principal Investigator: Cynthia Harper, PhD University of California, San Francisco
More Information

Additional Information:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00361400     History of Changes
Other Study ID Numbers: R01HD045480-03 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2006    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013

Keywords provided by University of California, San Francisco:
hormonal contraception

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs