- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00361400
Combined Hormonal Contraceptive Use in High Risk Women: A Longitudinal Study
August 1, 2013 updated by: University of California, San Francisco
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
1387
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Hayward, California, United States, 94541
- Planned Parenthood-Golden Gate
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Oakland, California, United States, 94605
- Planned Parenthood-Golden Gate
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Richmond, California, United States, 94806
- Planned Parenthood - Shasta Diablo
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San Francisco, California, United States, 94110
- University of California, San Francisco
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Vallejo, California, United States, 94590
- Planned Parenthood - Shasta Diablo
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Planned Parenthood patients who present to start a hormonal birth control for the first time.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Tina R Raine, MD, MPH, University of California, San Francisco
- Principal Investigator: Cynthia Harper, PhD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
August 4, 2006
First Submitted That Met QC Criteria
August 4, 2006
First Posted (Estimate)
August 8, 2006
Study Record Updates
Last Update Posted (Estimate)
August 2, 2013
Last Update Submitted That Met QC Criteria
August 1, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01HD045480-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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