Oral Contraceptive Pills Compared to Vaginal Rings

April 19, 2007 updated by: University of California, San Francisco

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

130

Phase

  • Not Applicable

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

  • United States
    • California
      • San Francisco, California, United States, 94110
        • New Generation Health Center

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 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Satisfaction

Secondary Outcome Measures

Outcome Measure
Compliance
Acceptability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Organon

Investigators

  • Principal Investigator: Felicia Stewart, MD, University of California, San Francisco

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

April 1, 2003

Study Completion

August 1, 2004

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 26, 2006

First Posted (Estimate)

July 27, 2006

Study Record Updates

Last Update Posted (Estimate)

April 23, 2007

Last Update Submitted That Met QC Criteria

April 19, 2007

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H10857-19674-04

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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