drugset / Trial / NCT02718378
Evaluation of Safety and Efficacy of Estetrol in Healthy Men
RandomizedParallel-groupTriple-blindBasic science
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.
Timeline
- Start
- 2016-03
- Primary completion
- 2017-02
- Completion
- 2017-02
Publications
- Results Phillips I, Shah SI, Duong T, Abel P, Langley RE. Androgen Deprivation Therapy and the Re-emergence of Parenteral Estrogen in Prostate Cancer. Oncol Hematol Rev. 2014 Spring;10(1):42-47. doi: 10.17925/ohr.2014.10.1.42.
- Results Coelingh Bennink HJ, Holinka CF, Diczfalusy E. Estetrol review: profile and potential clinical applications. Climacteric. 2008;11 Suppl 1:47-58. doi: 10.1080/13697130802073425.
- Coelingh Bennink HJT, Zimmerman Y, Verhoeven C, Dutman AE, Mensinga T, Kluft C, Reisman Y, Debruyne FMJ. A Dose-Escalating Study With the Fetal Estrogen Estetrol in Healthy Men. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3239-3249. doi: 10.1210/jc.2018-00147.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ESTETROL ANHYDROUS | Other / unclassified | 20 mg | Oral |
| Comparator | ESTETROL ANHYDROUS | Other / unclassified | 40 mg | Oral |
| Comparator | ESTETROL ANHYDROUS | Other / unclassified | 60 mg | Oral |