Secondary Hypogonadism Clinical Trial
Official title:
A Randomized, Open-Label, Fixed Dose, Active-Control, Multi-Center Phase IIB Study to Evaluate Fertility in Men With Secondary Hypogonadism, Comparing Androxal® to a Topical Testosterone in Men Previously Treated With Topical Testosterone.
The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.
The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone. A maximum of twelve subjects per group were randomized to daily treatments of Androxal® or topical testosterone (Testim®) for six months. The protocol was later amended to include a treatment group who received Androxal after a 3 month wash out period. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
NCT01739582 -
An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
|
Phase 3 | |
| Completed |
NCT01739595 -
Phase III Study to Evaluate Morning Testosterone Normalization in Overweight 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 |
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 |
NCT01923857 -
Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function
|
Phase 1 | |
| Completed |
NCT01532414 -
Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism
|
Phase 3 |