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

Tracking Information

First Received Date ^ICMJE

November 5, 2001

Last Updated Date

August 17, 2006

Start Date ^ICMJE

January 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00026013 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effects of Hypericum Perforatum on Effectiveness of Oral Contraceptives

Brief 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.

Detailed Description

See Brief Summary

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Single Blind, Placebo Control, Single Group Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Contraception

Intervention ^ICMJE

Drug: hypericum perforatum

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00026013

Responsible Party

Study ID Numbers ^ICMJE

R21 AT000836-01

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Patricia Murphy, DrPh

Columbia University

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP