The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant

Contraception Clinical Trial

Official title:

The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967055
• Other study ID #: 16-0614
• Status: Completed
• Start date: February 15, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 30, 2019
• Est. primary completion date: April 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Etonogestrel (ENG) Level	ENG levels will be measured prior to initiation of isotretinoin therapy.	Baseline (enrollment)
Primary	Serum Etonogestrel (ENG) Level	ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy.	4 weeks
Primary	Serum Etonogestrel (ENG) Level	ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy.	9 weeks