Oral Contraceptive Pills Compared to Vaginal Rings

NCT ID: NCT00357526

Last Updated: 2007-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-08-31

Brief Summary

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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

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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

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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OCPs

Intervention Type DRUG

vaginal ring

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Organon

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Principal Investigators

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Felicia Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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New Generation Health Center

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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H10857-19674-04

Identifier Type: -

Identifier Source: org_study_id