The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant

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

Study Overview

• Status: Completed
• Conditions: Contraception

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.

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Etonogestrel (ENG) Level	ENG levels will be measured prior to initiation of isotretinoin therapy.	Baseline (enrollment)
Serum Etonogestrel (ENG) Level	ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy.	4 weeks
Serum Etonogestrel (ENG) Level	ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy.	9 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Society of Family Planning

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2017
• Primary Completion (ACTUAL): April 28, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (ESTIMATE): November 17, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 16-0614

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO