The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT02967055
• Collaborator: Society of Family Planning (Other)
• Enrollment: 9
• Location: 1
• Actual Duration (Months): 28.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 9 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant
• Actual Study Start Date: Feb 15, 2017
• Actual Primary Completion Date: Apr 28, 2019
• Actual Study Completion Date: Jun 30, 2019

Outcome Measures

Primary Outcome Measures

1. Serum Etonogestrel (ENG) Level [Baseline (enrollment)]

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

2. Serum Etonogestrel (ENG) Level [4 weeks]

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

3. Serum Etonogestrel (ENG) Level [9 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Denver	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver
• Society of Family Planning

Investigators

• Principal Investigator: Aaron Lazorwitz, MD, University of Colorado, Denver

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 19, 2016

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT02967055
• Other Study ID Numbers: 16-0614
• First Posted: Nov 17, 2016
• Last Update Posted: Aug 11, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Arm/Group Title	Enrolled Participants
Arm/Group Description	Participants meeting all inclusion/exclusion criteria and enrolled into the study
Period Title: Overall Study
STARTED	54
In-person Screening	14
Enrolled	9
Completed 4 Week Follow-up Visit	8
COMPLETED	5
NOT COMPLETED	49

Baseline Characteristics

Arm/Group Title	Enrolled Participants
Arm/Group Description	Participants meeting all inclusion/exclusion criteria and enrolled into the study
Overall Participants	8
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	21
Sex: Female, Male (Count of Participants)
Female	8 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	6 75%
More than one race	0 0%
Unknown or Not Reported	2 25%
Body-mass index (kg/m^2) [Median (Full Range) ]
Median (Full Range) [kg/m^2]	27.4

Outcome Measures

1. Primary Outcome

Title	Serum Etonogestrel (ENG) Level
Description	ENG levels will be measured prior to initiation of isotretinoin therapy.
Time Frame	Baseline (enrollment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enrolled Participants
Arm/Group Description	Participants meeting all inclusion/exclusion criteria and enrolled into the study
Measure Participants	8
Median (Inter-Quartile Range) [pg/mL]	243.3

2. Primary Outcome

Title	Serum Etonogestrel (ENG) Level
Description	ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enrolled Participants
Arm/Group Description	Participants meeting all inclusion/exclusion criteria and enrolled into the study
Measure Participants	8
Median (Inter-Quartile Range) [pg/mL]	234.0

3. Primary Outcome

Title	Serum Etonogestrel (ENG) Level
Description	ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy.
Time Frame	9 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enrolled Participants
Arm/Group Description	Participants meeting all inclusion/exclusion criteria and enrolled into the study
Measure Participants	5
Median (Inter-Quartile Range) [pg/mL]	145.4

Adverse Events

Time Frame	20 weeks from onset of isotretinoin therapy
Adverse Event Reporting Description	Collected primarily any pregnancies
Arm/Group Title	Enrolled Participants
Arm/Group Description	Participants meeting all inclusion/exclusion criteria and enrolled into the study
All Cause Mortality
	Enrolled Participants
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Serious Adverse Events
	Enrolled Participants
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	Enrolled Participants
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.