drugset / Trial / NCT02419105
Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors
Phase 3
Terminated
91 enrolled
University of Zurich
Besins Healthcare (funding: investigator-initiated and independent grant) · collabCantonal Hospital of St. Gallen · collabCentre on Ageing and Mobility (Dr. Andreas Egli) · collabDr. Wild & Co. (funding: investigator-initiated and independent grant) · collabSwiss National Science Foundation · collabTufts University Jean Mayer USDA Human Nutrition Research Center on Aging · collabUniversity Hospital, Zürich · collab
RandomizedFactorialQuadruple-blindTreatment
Summary
The overall purpose of this study is to test the individual and combined effect of transdermal testosterone and/or Vitamin D in reducing fall risk and improve function in pre-frail hypogonadal senior men.
Timeline
- Start
- 2015-09
- Primary completion
- 2020-05
- Completion
- 2020-06
Outcome
Outcome not reported
Stopped (Enrollment): “Delayed recruitment mainly due to a screening to inclusion rate much lower than expected. Due to the delayed recruitment IMP reached the end of its shelf life.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cholecalciferol | Other / unclassified | 24000 iu | Oral |
| Comparator | Testosterone | Small molecule | 75 mg | Other |