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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014