Trials / Completed
CompletedNCT03512860
Estetrol (E4)/Drospirenone (DRSP) Drug-drug Interaction (DDI) Study
An Open-label, Two-way Cross-over Study to Determine the Effect of Multiple Doses of Valproic Acid on the Pharmacokinetics and Safety of a Single Oral Dose of Estetrol/Drospirenone in Healthy Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Estetra · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The present study is designed to determine the effect of valproic acid (VAL), a UGT2B7 inhibiting drug, on the pharmacokinetics (PK) of estetrol (E4)
Detailed description
In the present study, E4/DRSP will be administered alone (Treatment A) and in combination with VAL (Treatment B) following two sequences A-B or B-A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E4/DRSP | Administered as specified in the treatment arm. |
| DRUG | VAL | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2018-04-12
- Primary completion
- 2018-10-08
- Completion
- 2018-10-08
- First posted
- 2018-05-01
- Last updated
- 2018-12-14
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03512860. Inclusion in this directory is not an endorsement.