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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00361400
First received: August 4, 2006
Last updated: August 1, 2013
Last verified: August 2013
  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


Enrollment: 1387
Study Start Date: August 2005
Study Completion Date: September 2008
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
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

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00361400     History of Changes
Other Study ID Numbers: R01-HD045480-03
Study First Received: August 4, 2006
Last Updated: August 1, 2013
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 April 23, 2014