Trial Outcomes & Findings for Rifampin and the Contraceptive Implant (NCT NCT04463680)

Last Updated: 2023-05-16

Results Overview

Blood drawn before and after rifampin administration (2 weeks) for serum extraction and etonogestrel analysis

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

2 weeks

Results posted on

2023-05-16

Participant milestones
Measure	Rifampin 600 mg Will receive 2 week regimen of rifampin 600mg per day Rifampin 600 MG: Administered daily for 2 weeks
Overall Study STARTED	24
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	9

Reasons for withdrawal
Measure	Rifampin 600 mg Will receive 2 week regimen of rifampin 600mg per day Rifampin 600 MG: Administered daily for 2 weeks
Overall Study Not eligible due to laboratory criteria	5
Overall Study Not eligible due to implant duration of use	1
Overall Study Withdrawal by Subject	3

Rifampin and the Contraceptive Implant

Baseline characteristics by cohort
Measure	Rifampin 600 mg n=15 Participants Will receive 2 week regimen of rifampin 600mg per day Rifampin 600 MG: Administered daily for 2 weeks
Age, Continuous	28.2 years n=5 Participants
Sex: Female, Male Female	15 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	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants
Body mass index	25.2 kg/m^2 n=5 Participants
Duration of implant use	22 months n=5 Participants

Timeframe: 2 weeks

Blood drawn before and after rifampin administration (2 weeks) for serum extraction and etonogestrel analysis

Outcome measures
Measure	Rifampin 600 mg n=15 Participants Will receive 2 week regimen of rifampin 600mg per day Rifampin 600 MG: Administered daily for 2 weeks
Serum Etonogestrel Concentrations Baseline	164.0 pg/mL Interval 94.4 to 265.0
Serum Etonogestrel Concentrations Post-rifampin	47.8 pg/mL Interval 24.7 to 82.8

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Colorado Anschutz Medical Campus

Phone: 3037242019