PregnancyNCT00357526
Oral Contraceptive Pills Compared to Vaginal Rings
A study testing OCPs and vaginal ring in people with Pregnancy, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine whether teens and young women would prefer the Nuvaring to oral contraceptive pills after having tried both methods. Read more about this study
- Who is it for?
- Ages 15 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- OCPs and vaginal ring
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Aug 2004
- Phase
- Interventional
- 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 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Sexually active young women (n=130), English or Spanish speaking, aged 15-21 years, able and willing to try oral contraceptives and vaginal rings for 6 months
Who cannot join
- Not able or willing to use hormonal contraceptives, moving out of the area, pregnant or intending to become pregnant during the study time frame, not sexually active
Trial locations and contacts
1 site in 1 country.
United States1 site
New Generation Health Center
San Francisco, California, 94110
About this study
Official title: YOUNG WOMEN'S EXPERIENCES: ORAL CONTRACEPTIVE PILLS VS The VAGINAL RING
The purpose of this study is to determine whether teens and young women would prefer the Nuvaring to oral contraceptive pills after having tried both methods.
Read the detailed description
Sexually active young women (n=130), aged 15-21 years, were randomly assigned to use either the vaginal ring or oral contraceptive pills for an initial study interval of three 28-day cycles, followed by three cycles of the alternate method. Participants completed surveys about method use, acceptability and side effects at baseline, after three cycles, and after six cycles, as well as in a follow up telephone interview one month after study completion.
- Conditions
- Pregnancy
- Being tested
- OCPs, vaginal ring
- Keywords
- vaginal ring, Oral contraceptive pills, Teenagers, Young women, Patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCPsDrug
vaginal ringDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction
Secondary outcomes (2)
Compliance
Acceptability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startApr 2003
- Study completionAug 2004
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Organon
- Investigators
- Felicia Stewart, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357526
- Sponsor's protocol ID
- H10857-19674-04
- Status last verified
- Mar 2006
- First submitted
- 25 Jul 2006
- Last updated
- 23 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YOUNG WOMEN'S EXPERIENCES: ORAL CONTRACEPTIVE PILLS VS The VAGINAL RING
- ClinicalTrials.gov ID
- NCT00357526
- Acronym / sponsor ID
- H10857-19674-04
- Conditions
- Pregnancy
- Keywords
- vaginal ring, Oral contraceptive pills, Teenagers, Young women, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Organon
- Study start
- Apr 2003
- Study completion
- Aug 2004
- First posted
- 27 Jul 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.
The purpose of this study is to determine whether teens and young women would prefer the Nuvaring to oral contraceptive pills after having tried both methods.
Detailed description
Sexually active young women (n=130), aged 15-21 years, were randomly assigned to use either the vaginal ring or oral contraceptive pills for an initial study interval of three 28-day cycles, followed by three cycles of the alternate method. Participants completed surveys about method use, acceptability and side effects at baseline, after three cycles, and after six cycles, as well as in a follow up telephone interview one month after study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Sexually active young women (n=130), English or Spanish speaking, aged 15-21 years, able and willing to try oral contraceptives and vaginal rings for 6 months
Key exclusion criteria (1 listed)
- Not able or willing to use hormonal contraceptives, moving out of the area, pregnant or intending to become pregnant during the study time frame, 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCPs | Drug | – |
| vaginal ring | Device | – |
Primary outcome
Satisfaction
2 secondary outcomes
Compliance
Acceptability
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 23 Apr 2007.
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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.
Felicia Stewart, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCPs and vaginal ring in people with Pregnancy, run by University of California, San Francisco at 1 site 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 23 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Satisfaction. It is what the study was designed to measure, not a finding.
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 23 Apr 2007.