Trials / Completed
CompletedNCT03335163
The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum Etonogestrel (ENG) levels in contraceptive implant users.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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 |
Timeline
- Start date
- 2018-03-15
- Primary completion
- 2021-04-22
- Completion
- 2021-04-22
- First posted
- 2017-11-07
- Last updated
- 2022-07-13
- Results posted
- 2022-07-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03335163. Inclusion in this directory is not an endorsement.