The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant

NCT02967055 | Completed Results

• 1 other identifier: 16-0614
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contraception

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Currently breastfeeding
• Known contraindications to isotretinoin
• Currently taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Society of Family Planning: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Results Point of Contact

• Title: Aaron Lazorwitz
• Organization: University of Colorado Anschutz Medical Campus

aaron.lazorwitz@cuanschutz.edu

3037242019

Study Officials

• Aaron Lazorwitz, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 17, 2016
• Study Start: February 15, 2017
• Primary Completion: April 28, 2019
• Study Completion: June 30, 2019
• Last Updated: August 11, 2020
• Results First Posted: August 11, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)