PregnancyNCT00361400
Combined Hormonal Contraceptive Use in High Risk Women: A Longitudinal Study
An observational study of Pregnancy, run by University of California, San Francisco at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 1,387 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2005to Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Planned Parenthood patients who present to start a hormonal birth control for the first time.
Who may be able to join
- 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
Who cannot join
- Past user of method, Married, Pregnant, Moving out of area, Not sexually active
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Planned Parenthood-Golden Gate
Hayward, California, 94541
Planned Parenthood-Golden Gate
Oakland, California, 94605
Planned Parenthood - Shasta Diablo
Richmond, California, 94806
University of California, San Francisco
San Francisco, California, 94110
Planned Parenthood - Shasta Diablo
Vallejo, California, 94590
About this study
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.
Read the 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.
- Conditions
- Pregnancy
- Keywords
- pregnancy, hormonal contraception
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startAug 2005
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,387 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Tina R Raine, MD, MPH, Principal investigator, University of California, San FranciscoCynthia Harper, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361400
- Sponsor's protocol ID
- R01HD045480-03
- Status last verified
- Aug 2013
- First submitted
- 4 Aug 2006
- Last updated
- 2 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Hormonal Contraceptive Use in High Risk Women: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT00361400
- Acronym / sponsor ID
- R01HD045480-03
- Conditions
- Pregnancy
- Keywords
- pregnancy, hormonal contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,387 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 8 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Planned Parenthood patients who present to start a hormonal birth control for the first time.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Past user of method, Married, Pregnant, Moving out of area, Not sexually active
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina R Raine, MD, MPH principal investigator
University of California, San Francisco
Cynthia Harper, PhD principal investigator
University of California, San Francisco
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University of California, San Francisco at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.