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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by University of California, San Francisco.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00361400
First received: August 4, 2006
Last updated: May 19, 2008
Last verified: May 2008
History of Changes
  Purpose

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
Pregnancy

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Combined Hormonal Contraceptive Use in High Risk Women: A Longitudinal Study

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

Biospecimen Retention:   Samples Without DNA

urine for pregnancy testing


Estimated Enrollment: 1600
Study Start Date: August 2005
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years to 24 Years
Genders 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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361400

Locations
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)
Investigators
Principal Investigator: Tina R Raine, MD, MPH University of California, San Francisco
Principal Investigator: Cynthia Harper, PhD University of California, San Francisco
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00361400     History of Changes
Other Study ID Numbers: R01-HD045480-03
Study First Received: August 4, 2006
Last Updated: May 19, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013