Oral Contraceptive Pills Compared to Vaginal Rings

Pregnancy Clinical Trial

Official title:

YOUNG WOMEN’S EXPERIENCES: ORAL CONTRACEPTIVE PILLS VS The VAGINAL RING

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357526
• Other study ID #: H10857-19674-04
• Status: Completed
• Phase: N/A
• First received: July 25, 2006
• Last updated: April 19, 2007
• Start date: April 2003
• Est. completion date: August 2004

Study information

• Verified date: March 2006
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 21 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• OCPs

Device:
• vaginal ring

Locations

Country	Name	City	State
United States	New Generation Health Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Organon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction
Secondary	Compliance
Secondary	Acceptability