drugset / Trial / NCT03363997
Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days
Phase 1
Completed
31 enrolled
Galeno Desenvolvimento de Pesquisas Clínicas
SocraTec R&D GmbH · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This clinical trial evaluated the pharmacokinetics and pharmacodynamics of estriol in healthy post-menopausal women after the application of one vaginal ring containing one of three different dosages of estriol (100 mg (Test 1), 300 mg (Test 2) or 600 mg (Test 3)) with continuous delivery (0.125, 0.250 or 0.500 mg/day) for 21 days. And also, characterized its safety and tolerability.
Timeline
- Start
- 2016-09-23
- Primary completion
- 2016-12-15
- Completion
- 2017-06-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estriol | Unknown | 0.125 mg | Other |
| Subject | Estriol | Unknown | 0.25 mg | Other |
| Subject | Estriol | Unknown | 0.5 mg | Other |
Indications
No indication recorded.