The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant



Status:Recruiting
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 45
Updated:3/30/2019
Start Date:October 2016
End Date:March 2020
Contact:Rebecca Seale
Email:Rebecca.Seale@ucdenver.edu
Phone:303-724-2013

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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.

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
We found this trial at
1
site
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Aaron Lazorwitz, MD
Phone: 303-724-2013
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Aurora, CO
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