Trial Outcomes & Findings for The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users (NCT NCT03335163)
NCT ID: NCT03335163
Last Updated: 2022-07-13
Results Overview
The investigators will collect serum from participants at enrollment and at each of the three study follow-up visits. All samples will be batched for analysis. Analysis will be performed using a liquid-chromatography mass-spectrometry validated assay for measurement of serum etonogestrel concentration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Enrollment (Baseline), 4 weeks (Visit 2), 5 weeks (Visit 3), 6 weeks (Visit 4)
Results posted on
2022-07-13
Participant Flow
Participant milestones
| Measure |
ENG Implant Users
Healthy women using an ENG implant for at least 12 months and no greater than 36 months will be administered a 6 week titration schedule of topiramate to a max dose of 200mg bid by the final week.
Topiramate: Topiramate - Participants will undergo a 6 week titrated regimen of oral topiramate to reach a maximum dose of 400mg per day:
Week 1 - topiramate PO 25mg daily Week 2 - topiramate PO 25mg twice daily Week 3 - topiramate PO 50mg twice daily Week 4 - topiramate PO 100mg twice daily Week 5 - topiramate PO 150mg twice daily Week 6 - topiramate PO 200mg twice daily
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
Completed Visit 2
|
32
|
|
Overall Study
Completed Visit 3
|
31
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
ENG Implant Users
Healthy women using an ENG implant for at least 12 months and no greater than 36 months will be administered a 6 week titration schedule of topiramate to a max dose of 200mg bid by the final week.
Topiramate: Topiramate - Participants will undergo a 6 week titrated regimen of oral topiramate to reach a maximum dose of 400mg per day:
Week 1 - topiramate PO 25mg daily Week 2 - topiramate PO 25mg twice daily Week 3 - topiramate PO 50mg twice daily Week 4 - topiramate PO 100mg twice daily Week 5 - topiramate PO 150mg twice daily Week 6 - topiramate PO 200mg twice daily
|
|---|---|
|
Overall Study
Not eligible due to laboratory criteria
|
3
|
|
Overall Study
Withdrawal by Subject
|
18
|
Baseline Characteristics
The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Baseline characteristics by cohort
| Measure |
ENG Implant Users
n=32 Participants
Healthy women using an ENG implant for at least 12 months and no greater than 36 months will be administered a 6 week titration schedule of topiramate to a max dose of 200mg bid by the final week.
Topiramate: Topiramate - Participants will undergo a 6 week titrated regimen of oral topiramate to reach a maximum dose of 400mg per day:
Week 1 - topiramate PO 25mg daily Week 2 - topiramate PO 25mg twice daily Week 3 - topiramate PO 50mg twice daily Week 4 - topiramate PO 100mg twice daily Week 5 - topiramate PO 150mg twice daily Week 6 - topiramate PO 200mg twice daily
|
|---|---|
|
Age, Continuous
|
25.3 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=93 Participants
|
|
Body-mass index
|
25.5 kg/m^2
n=93 Participants
|
|
Duration of implant use
|
24 months
n=93 Participants
|
PRIMARY outcome
Timeframe: Enrollment (Baseline), 4 weeks (Visit 2), 5 weeks (Visit 3), 6 weeks (Visit 4)Population: Due to early discontinuation from the study, data are available for only 31 participants for Visit 3 and 27 participants for Visit 4.
The investigators will collect serum from participants at enrollment and at each of the three study follow-up visits. All samples will be batched for analysis. Analysis will be performed using a liquid-chromatography mass-spectrometry validated assay for measurement of serum etonogestrel concentration.
Outcome measures
| Measure |
ENG Implant Users
n=32 Participants
Healthy women using an ENG implant for at least 12 months and no greater than 36 months will be administered a 6 week titration schedule of topiramate to a max dose of 200mg bid by the final week.
Topiramate: Topiramate - Participants will undergo a 6 week titrated regimen of oral topiramate to reach a maximum dose of 400mg per day:
Week 1 - topiramate PO 25mg daily Week 2 - topiramate PO 25mg twice daily Week 3 - topiramate PO 50mg twice daily Week 4 - topiramate PO 100mg twice daily Week 5 - topiramate PO 150mg twice daily Week 6 - topiramate PO 200mg twice daily
|
|---|---|
|
Serum Etonogestrel Concentrations
Baseline
|
142.0 pg/mL
Interval 76.2 to 771.0
|
|
Serum Etonogestrel Concentrations
Visit 2
|
126.0 pg/mL
Interval 72.4 to 585.0
|
|
Serum Etonogestrel Concentrations
Visit 3
|
119.0 pg/mL
Interval 65.6 to 542.0
|
|
Serum Etonogestrel Concentrations
Visit 4
|
105.0 pg/mL
Interval 46.2 to 859.0
|
Adverse Events
ENG Implant Users
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
Dr. Aaron Lazorwitz
University of Colorado Anschutz Medical Campus
Phone: 3037242019
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place