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Fispemifene in older men with hypogonadism
NCT00290134Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2006
- Countries
- 1
- Sponsor
- QuatRx Pharmaceuticals
- Drugs
- fispemifene
- Conditions
- Hypogonadism
01
Overview
Phase 2, randomised, double-blind trial of fispemifene in Hypogonadism (4 arms), sponsored by QuatRx Pharmaceuticals. Primary endpoint: Change in morning total testosterone levels from baseline to Week 4. Started Feb 2006; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Fispemifene 100 mg
100 mg daily oral dose
Fispemifene 200 mg
200 mg daily oral dose
Fispemifene 300 mg
300 mg daily oral dose
Placebo
Daily oral placebo
03
Who it enrols
Older men with total testosterone < 240 ng/dL and normal LH/FSH levels, excluding those with prostate/breast cancer, BPH, or significant cardiovascular disease.
04
Endpoints
Primary
Change in morning total testosterone levels from baseline to Week 4
Secondary
Change in total testosterone levels from baseline to Weeks 2 and 6
Change in free testosterone from baseline to Weeks 2, 4, and 6
Change in calculated free testosterone from baseline to Weeks 2, 4, and 6
Change in dihydrotestosterone from baseline to Weeks 2, 4, and 6
Change in sex hormone-binding globulin from baseline to Weeks 2, 4, and 6
Change in estradiol from baseline to Weeks 2, 4, and 6
Change in luteinizing hormone from baseline to Weeks 2, 4, and 6
Change in follicle-stimulating hormone from baseline to Weeks 2, 4, and 6
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