The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant
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This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.
Condition or disease
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Reproductive-aged women (18-45) who are under the care of a dermatologist for treatment of acne and planning to initiate therapy with isotretinoin. The women must have chosen an ENG contraceptive implant for their primary mechanism of birth control, placed at least four weeks prior to study enrollment, but in place no longer than three years.
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
Known contraindications to isotretinoin
Currently taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors