The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant
Completed
Conditions studied: Contraception
In brief
This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.
Key facts
- Study ID
- NCT02967055
- Run by
- University of Colorado, Denver
- People needed
- 9
- Starts
- 2017-02-15
- Expected to finish
- 2019-06-30
- Last updated by the study team
- 2020-08-11
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Have a secondary form of non-hormonal contraception or abstain during isotretinoin therapy and four weeks afterwards
- Have at least two negative pregnancy tests at least 19 days apart prior to initiating isotretinoin therapy
- Have normal baseline laboratory evaluation including liver function tests, basic metabolic panel, and complete blood count
- Willing to abstain from taking any Vitamin A supplement during the study period
- Have a Body Mass Index (BMI) >= 18.5
You may not qualify if…
- Currently breastfeeding
- Known contraindications to isotretinoin
- Currently taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors
Where it is running
- University of Colorado Denver — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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