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Oral Contraceptive Pills Compared to Vaginal Rings

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ClinicalTrials.gov Identifier: NCT00357526
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : April 23, 2007
Sponsor:
Collaborator:
Organon
Information provided by:
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Drug: OCPs Device: vaginal ring Not Applicable

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  (Clinical Trial)
Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: YOUNG WOMEN’S EXPERIENCES: ORAL CONTRACEPTIVE PILLS VS The VAGINAL RING
Study Start Date : April 2003
Study Completion Date : August 2004



Primary Outcome Measures :
  1. Satisfaction

Secondary Outcome Measures :
  1. Compliance
  2. Acceptability


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Ages Eligible for Study:   15 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357526


Locations
United States, California
New Generation Health Center
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Organon
Investigators
Principal Investigator: Felicia Stewart, MD University of California, San Francisco

ClinicalTrials.gov Identifier: NCT00357526     History of Changes
Other Study ID Numbers: H10857-19674-04
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: April 23, 2007
Last Verified: March 2006

Keywords provided by University of California, San Francisco:
vaginal ring
Oral contraceptive pills
Teenagers
Young women
Patient satisfaction

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female