The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant
Completed
- Conditions
- Contraception
- Registration Number
- NCT02967055
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.
- Detailed Description
The Investigators will enroll only women with an etonogestrel contraceptive implant in place who are initiating isotretinoin therapy through their dermatologist. The Investigators will monitor the subjects serum etonogestrel concentration during isotretinoin therapy but no medications will be provided through this study. No medical devices will be inserted as part of this study either.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 9
Inclusion Criteria
- 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
Exclusion Criteria
- Currently breastfeeding
- Known contraindications to isotretinoin
- Currently taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum Etonogestrel (ENG) Level 9 weeks ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Colorado Denver
🇺🇸Aurora, Colorado, United States