Oral Contraceptive Pills Compared to Vaginal Rings

This study has been completed.
Sponsor:
Collaborator:
Organon
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00357526
First received: July 25, 2006
Last updated: April 19, 2007
Last verified: March 2006
  Purpose

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 Intervention
Pregnancy
Drug: OCPs
Device: vaginal ring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: YOUNG WOMEN’S EXPERIENCES: ORAL CONTRACEPTIVE PILLS VS The VAGINAL RING

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Satisfaction

Secondary Outcome Measures:
  • Compliance
  • Acceptability

Estimated Enrollment: 130
Study Start Date: April 2003
Estimated Study Completion Date: August 2004
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.

  Eligibility

Ages Eligible for Study:   15 Years to 21 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00357526     History of Changes
Other Study ID Numbers: H10857-19674-04
Study First Received: July 25, 2006
Last Updated: April 19, 2007
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 19, 2014