The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant

University of Colorado, Denver9 enrolled

Overview

This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Contraception

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Colorado Denver

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Serum Etonogestrel (ENG) Level

ENG levels will be measured prior to initiation of isotretinoin therapy.

Time frame: Baseline (enrollment)

Serum Etonogestrel (ENG) Level

ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy.

Time frame: 4 weeks

Serum Etonogestrel (ENG) Level

ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy.

Time frame: 9 weeks

Data from ClinicalTrials.gov

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