NCT05096169

Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Male
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open-label trial examining two doses of clomiphene citrate in men with low serum testosterone concentrations (total testosterone (TT) \< 300 ng/dl).

Detailed description

This is a randomized, open-label trial examining two doses of clomiphene citrate in men with low serum testosterone concentrations (total testosterone (TT) \< 300 ng/dl). The investigators will perform a pharmacokinetic analysis of serum hormone concentrations (TT, LH, FSH, estradiol) after medication administration. Researchers hypothesize that testosterone levels will increase in both groups and this may allow to dose clomiphene citrate so that patients do not need to take the medication daily.

Conditions

• Testosterone Deficiency

Interventions

Type	Name	Description
DRUG	Clomiphene Citrate 25mg	clomiphene citrate at a dose of 25mg daily
DRUG	Clomiphene Citrate 50mg	clomiphene citrate at a dose of 50mg every other day

Timeline

• Start date: 2022-05-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2021-10-27
• Last updated: 2024-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study