NCT00026013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2002

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2001

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2002

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
Last Updated

August 18, 2006

Status Verified

July 1, 2006

First QC Date

November 5, 2001

Last Update Submit

August 17, 2006

Conditions

Contraception

Keywords

contraceptionhormonal contraceptionherbal remedieshypericum perforatumcontraceptive effectiveness

Interventions

hypericum perforatumDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Department of Obstetrics & Gynecology

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Hypericum extract LI 160

Study Officials

  • Patricia Murphy, DrPh

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

November 5, 2001

First Posted

November 6, 2001

Study Start

January 1, 2002

Study Completion

January 1, 2004

Last Updated

August 18, 2006

Record last verified: 2006-07

Locations

US(1)