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NCT01739582 Clinical Trial

An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

Secondary Hypogonadism Clinical Trial

Official title:
An Open Label, 6 Month Phase III Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01739582
Other study ID # ZA-301EXT
Secondary ID
Status Completed
Phase Phase 3
First received November 29, 2012
Last updated April 15, 2014
Start date November 2012
Est. completion date April 2014

Study information
Verified date April 2014
Source Repros Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To determine the safety profile of Androxal in men with secondary hypogonadism.

Description:

This study is an open-label, multi-center Phase 3 extension study to evaluate the safety on continued treatment with Androxal in subjects who completed either ZA-301 or ZA-302. The study requires 6 study visits (1 for an eye exam) and is approximately 7 months in duration. Subjects will be treated for 26 weeks, starting at a daily dose of 12.5 mg. At Visit 2 (Week 6) subjects who do not achieve morning T values ≥450 ng/dL will be up-titrated to 25 mg. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy, refraction eye exams, clinical laboratory tests and adverse event reporting.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

• Successful completion of either ZA-301 or ZA-302

Exclusion Criteria:

• Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Androxal

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Repros Therapeutics Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Testosterone levels Values of total morning testosterone levels at each visit 26 weeks No
Secondary Follicle Stimulating Hormone and Leutinizing Hormone Values of Follicle Stimulating Hormone (FSH) and Leutinizing Hormone (LH) at each visit 26 weeks No
Secondary Diabetic Parameters Changes in HbA1c, fasting plasma glucose (FPG), insulin, and homeostasis model assessment-insulin resistance (HOMA-IR) for those subjects with Type II diabetes 26 weeks No
Secondary Change in weight and body mass index (BMI) Change in weight and BMI 26 weeks No
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
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 NCT01067365 - 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 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 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 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 NCT01923857 - Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function 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

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