Trial Outcomes & Findings for The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant (NCT NCT02967055)

NCT ID: NCT02967055

Last Updated: 2020-08-11

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 9 participants
• Primary outcome timeframe: Baseline (enrollment)
• Results posted on: 2020-08-11

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Enrolled Participants Participants meeting all inclusion/exclusion criteria and enrolled into the study
Overall Study Excluded	40
Overall Study Screen fail	3
Overall Study Lost to Follow-up	2
Overall Study Stopped due to side effects	3
Overall Study Stopped due to drug cost	1

Baseline Characteristics

The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant

Baseline characteristics by cohort

Measure	Enrolled Participants n=8 Participants Participants meeting all inclusion/exclusion criteria and enrolled into the study
Age, Continuous	21 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Body-mass index	27.4 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Baseline (enrollment)

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

Outcome measures

Measure	Enrolled Participants n=8 Participants Participants meeting all inclusion/exclusion criteria and enrolled into the study
Serum Etonogestrel (ENG) Level	243.3 pg/mL Interval 166.14 to 294.5

PRIMARY outcome

Timeframe: 4 weeks

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

Outcome measures

Measure	Enrolled Participants n=8 Participants Participants meeting all inclusion/exclusion criteria and enrolled into the study
Serum Etonogestrel (ENG) Level	234.0 pg/mL Interval 185.0 to 256.9

PRIMARY outcome

Timeframe: 9 weeks

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

Outcome measures

Measure	Enrolled Participants n=5 Participants Participants meeting all inclusion/exclusion criteria and enrolled into the study
Serum Etonogestrel (ENG) Level	145.4 pg/mL Interval 138.6 to 235.4

Adverse Events

Enrolled Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aaron Lazorwitz

University of Colorado Anschutz Medical Campus

Phone: 3037242019

Email: aaron.lazorwitz@cuanschutz.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place