CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 36 enrolled
Drug / intervention
Levonorgestrel +2 moredrug
Likely dose
St. John's Wort orally for 4-6 weeks; Levonorgestrel single oral doseAI-extracted
Key inclusion· 2
  • ✓Body mass index (BMI) between 20 and 25
  • ✓Regular menstrual cycles for at least 3 months prior to study entry
Key exclusion· 2
  • ✕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

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00131885
NCT00131885Phase 4Completed
CompareCT.gov

Effects of St. John's Wort on Levonorgestrel

University of Utah·interventional·Posted Aug 19, 2005·Updated Nov 13, 2023

In Brief

A Phase 4 clinical trial evaluating Placebo Control (Placebo Herb), St. John's Wort, and 1 other intervention for Contraception. Completed, enrolled 36 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States
CollaboratorsNational Center for Complementary and Integrative Health (NCCIH)

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 19, 2005
Enrollment StartAug 1, 2005
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.9 years ago

Interventions

Placebo Control (Placebo Herb)dietary

Placebo herb three times daily (ground cellulose) for 4-6 weeks

St. John's Wortdietary

St. John's Wort (Hypericum perforatum) orally or 4-6 weeks

Levonorgestreldrug

Levonorgestrel in a single oral dose