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

This study has been completed.

First Received: November 5, 2001 Last Updated: August 17, 2006 History of Changes

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00026013

Purpose

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.

Condition	Intervention
Contraception	Drug: hypericum perforatum

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind, Placebo Control, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Effects of Hypericum Perforatum on Effectiveness of Oral Contraceptives

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	25
Study Start Date:	January 2002
Estimated Study Completion Date:	January 2004

Detailed Description:

See Brief Summary

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Women taking or willing to take low dose oral contraceptives for 5 months
No contraindications to hormonal contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026013

Locations

United States, New York
Columbia University Department of Obstetrics & Gynecology
New York, New York, United States, 10032

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Patricia Murphy, DrPh

Columbia University

More Information

No publications provided

Study ID Numbers:	R21 AT000836-01
Study First Received:	November 5, 2001
Last Updated:	August 17, 2006
ClinicalTrials.gov Identifier:	NCT00026013 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

contraception
hormonal contraception
herbal remedies
hypericum perforatum
contraceptive effectiveness

Study placed in the following topic categories:

Contraceptive Agents
Contraceptives, Oral
Contraceptive Agents, Female
St. John's Wort

Additional relevant MeSH terms:

Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptives, Oral

Contraceptive Agents, Female
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009