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Completed

NCT Number: NCT02967055

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.

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Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Serum Etonogestrel (ENG) Level

    Time frame: Baseline (enrollment)

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

  2. Serum Etonogestrel (ENG) Level

    Time frame: 4 weeks

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

  3. Serum Etonogestrel (ENG) Level

    Time frame: 9 weeks

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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Society of Family Planning

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2016
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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