Trials / Completed
CompletedNCT02718378
Evaluation of Safety and Efficacy of Estetrol in Healthy Men
A Phase I, Double-blind, Randomised, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Multiple Dosages of Estetrol in Healthy Men
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Pantarhei Oncology B.V. · Academic / Other
- Sex
- Male
- Age
- 40 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
The current study is designed as a phase Ib multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of E4 in healthy men after daily oral administration for 28 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | estetrol | |
| DRUG | placebo |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2017-02-01
- Completion
- 2017-02-01
- First posted
- 2016-03-24
- Last updated
- 2017-02-09
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02718378. Inclusion in this directory is not an endorsement.