Clinical Trials Logo
  1. Home
  2. Secondary Hypogonadism
  3. NCT01923857

Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function

Secondary Hypogonadism Clinical Trial

Official title:
A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety Profile of Androxal in Male Subjects With Impaired Renal Function

Clinical Trial Summary

- To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with various stages of renal impairment and in volunteers with normal renal function.

- To compare the safety profile of a single dose of 25 mg Androxal in overweight male subjects with various stages of renal impairment and in volunteers with normal renal function.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01923857
Study type Interventional
Source Repros Therapeutics Inc.
Contact
Status Completed
Phase Phase 1
Start date August 2013
Completion date August 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT01454011 - The Effect of Testosterone Replacement on the High Density Lipoprotein Cholesterol Subgroups Phase 4
Completed NCT01191320 - Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus Phase 2
Completed NCT01739595 - Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism Phase 3
Completed NCT01739582 - An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism Phase 3
Active, not recruiting NCT02443090 - Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men Phase 2
Completed NCT01534208 - Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism Phase 3
Completed NCT00962637 - Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Phase 3
Completed NCT00467870 - Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men Phase 3
Completed NCT01067365 - Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism Phase 3
Completed NCT01386606 - The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone) Phase 2
Completed NCT00706719 - To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone Phase 2
Completed NCT00911586 - Pharmacokinetic Study to Determine Time to Steady-state Phase 2
Completed NCT01993225 - A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62% Phase 3
Completed NCT01993212 - A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62% Phase 3
Completed NCT01270841 - Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism Phase 2
Completed NCT02274181 - An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration Phase 1
Completed NCT01923870 - Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function Phase 1
Completed NCT01532414 - Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism Phase 3