Secondary Hypogonadism Clinical Trial
Official title:
Phase 4 Study That Compares the High Density Lipoprotein Cholesterol (HDL) Cholesterol Subgroups of the Patients With Congenital Hypogonadotrophic Hypogonadism With That of the Healthy Control Subjects, and Investigates the Effect of Testosterone Treatment on HDL Subgroups.
The study is designed to answer the following questions:
1. Is there any difference between the compositions of the HDL cholesterol subpopulations
of patients with hypogonadism and the healthy controls.
2. What is the effect of testosterone replacement therapy on the distributions of HDL
subgroups.
3. Is there any difference between the effects of the two different testosteron
replacement regiments
This study has two designs:
1. The case control design to search for the difference between the HDL subgroups and the
other metabolic parameters between the healthy subjects and the patients with
hypogonadism
2. The follow-up study to search for the effects of two different testosterone replacement
regiments.
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| 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 |
NCT01067365 -
Study to Evaluate the Safety and Efficacy of Androxal Treatment in 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 |
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 |
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 |