The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant

NCT ID: NCT02967055

Last Updated: 2020-08-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-15

Study Completion Date

2019-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Society of Family Planning

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron Lazorwitz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16-0614

Identifier Type: -

Identifier Source: org_study_id

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