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

NCTNCT01739582Other idZA-301EXT

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 300 participants (estimated)
Sponsor: Repros Therapeutics Inc. · Industry
Design: Not randomized · Open label (no masking)
Countries: Not stated
Start: Nov 2012
Primary completion: Apr 2014
Completion: Apr 2014
First posted: 3 Dec 2012 (estimated)
Last update posted: 16 Apr 2014 (estimated)
Conditions: Secondary Hypogonadism

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2012201320142015

Ph 3
An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
NCT01739582
Nov 2012 to Apr 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

AndroxalDrug

Arms1

Experimental
Androxal
Androxal (enclomiphene citrate) 12.5 mg, once daily, oral capsule. Subjects will be up-titrated to 25 mg if testosterone levels remain below 450 ng/dL at visit 2.

Primary outcomes1

Outcomes the sponsor listed as primary.

Testosterone levels
Time frame · 26 weeks
Registry description
Values of total morning testosterone levels at each visit

Secondary outcomes(3)

Follicle Stimulating Hormone and Leutinizing Hormone
Time frame · 26 weeks
Registry description
Values of Follicle Stimulating Hormone (FSH) and Leutinizing Hormone (LH) at each visit
Diabetic Parameters
Time frame · 26 weeks
Registry description
Changes in HbA1c, fasting plasma glucose (FPG), insulin, and homeostasis model assessment-insulin resistance (HOMA-IR) for those subjects with Type II diabetes
Change in weight and body mass index (BMI)
Time frame · 26 weeks
Registry description
Change in weight and BMI

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 60 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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