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Effects of St. John's Wort on the Oral Contraceptive Hormone Levonorgestrel

This study has been completed.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00131885
  Purpose

This study will determine the effects of St. John's wort, a common herbal remedy, on metabolism of the female contraceptive hormone levonorgestrel.


Condition Intervention Phase
Contraception
Drug: St. John's wort (Hypericum perforatum)
Phase IV

MedlinePlus related topics:   Birth Control    Menstruation   

ChemIDplus related topics:   Levonorgestrel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:   Effects of St. John's Wort on Levonorgestrel

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

Primary Outcome Measures:
  • Pharmacokinetic studies between Days 9 and 12 of the menstrual cycle before and during treatment with St. John's wort or placebo [ Time Frame: Days 9 and 12 of the menstrual cycle ] [ Designated as safety issue: No ]
  • ovulation defined as progesterone levels 3.0 ng/ml [ Time Frame: weekly intervals after dosing until menses ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean levels of follicle-stimulating hormone, estradiol-17b (E2), luteinizing hormone, inhibin, and glycodelin drawn at weekly intervals until next menses [ Time Frame: weekly intervals until next menses ] [ Designated as safety issue: No ]

Enrollment:   36
Study Start Date:   August 2005
Study Completion Date:   May 2008
Primary Completion Date:   May 2008 (Final data collection date for primary outcome measure)

Detailed Description:

In the last decade, St. John's wort has become one of the most commonly used botanicals. Levonorgestrel is a form of progesterone, a female hormone involved in conception. It can be given as both a pill and an injection and is used for contraception and for the treatment of endometriosis. However, evidence suggests that St. John's wort may reduce the effectiveness of the contraceptive hormone levonorgestrel. This study will determine whether interactions between St. John's wort and levonorgestrel reduce the effectiveness of the hormone. This study will also determine whether a higher dose of levonorgestrel will override the effects of St. John's wort.

All participants will receive a single dose of levonorgestrel between Days 9 and 12 of their first menstrual cycle after entering this study. Blood and urine collection will occur immediately after the levonorgestrel is given and every week until participants' next menstrual cycle to determine the levels of reproductive hormones in participants' bodies.

At the beginning of participants' next menstrual cycle, they will be randomly assigned to one of four groups and receive either St. John's wort or placebo for 6 weeks. Group 1 will receive a placebo; Groups 2 and 3 will receive a standard dose of St. John's wort (900 mg per day); and Group 4 will receive an increased dose of St. John's wort (1500 mg per day). After 6 weeks, Groups 1, 2, and 4 will receive 150 mcg levonorgestrel; and Group 3 will receive 225 mcg levonorgestrel. Blood and urine collection will occur immediately after levonorgestrel is given and every week until participants' next menstrual cycle.

  Eligibility
Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 20 and 25
  • Regular menstrual cycles for at least 3 months prior to study entry

Exclusion Criteria:

  • Current use of foods, herbs, vitamins, over-the-counter supplements, or any medications that could alter pharmacokinetics of other drugs
  • Medical contraindications to the use of contraceptives
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131885

Locations
United States, Utah
University of Utah    
      Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

Investigators
Principal Investigator:     Patricia A. Murphy, DrPH     College of Nursing, University of Utah    
  More Information


Publications:

Study ID Numbers:   R21 AT002297
First Received:   August 17, 2005
Last Updated:   August 11, 2008
ClinicalTrials.gov Identifier:   NCT00131885
Health Authority:   United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Menstruation  
Complementary Therapies  
Pharmacokinetics  
Hypericum  
St. John's wort
Levonorgestrel
Women

Study placed in the following topic categories:
Levonorgestrel

Additional relevant MeSH terms:
Contraceptive Agents
Therapeutic Uses
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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