Effects of St. John's Wort on the Effectiveness of Oral Contraceptives

Contraception Clinical Trial

Official title:

Effects of Hypericum Perforatum on Effectiveness of Oral Contraceptives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00026013
• Other study ID #: R21AT000836-01
• Status: Completed
• Phase: N/A
• First received: November 5, 2001
• Last updated: August 17, 2006
• Start date: January 2002
• Est. completion date: January 2004

Study information

• Verified date: July 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of a common herbal remedy, St. John's Wort, on the effectiveness of birth control pills. St. John's Wort has recently been shown to increase metabolism of some drugs. If it could increase metabolism of oral contraceptives as well, it may increase the risk of contraceptive failure and unintended pregnancy. Study participants will be evaluated for risk of ovulation on oral contraceptives before and during simultaneous therapy with St. John's Wort.

Description:

See Brief Summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women taking or willing to take low dose oral contraceptives for 5 months

• No contraindications to hormonal contraception

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• hypericum perforatum

Locations

Country	Name	City	State
United States	Columbia University Department of Obstetrics & Gynecology	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,