Trial intelligence / Profile preview

Androxal Extension Study for Secondary Hypogonadism

NCT01739582Phase 3

Key facts

Status: Completed
Start: Nov 2012
Primary completion: Apr 2014
Sponsor: Repros Therapeutics Inc.
Modality: Small Molecules

Drugs: enclomiphene
Conditions: secondary hypogonadism (HH)

Overview

Phase 3, open-label, single-arm trial of enclomiphene in secondary hypogonadism (HH), sponsored by Repros Therapeutics Inc. Primary endpoint: Testosterone at 26 weeks. Started Nov 2012; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Androxal
Open-label treatment with enclomiphene citrate.

Who it enrols

Men with secondary hypogonadism who successfully completed study ZA-301 or ZA-302.

Endpoints

Primary

Testosterone26 weeks

Secondary

Follicle Stimulating Hormone26 weeks
Luteinizing Hormone26 weeks
Diabetic Parameters26 weeks
Weight26 weeks
Body Mass Index26 weeks
Adverse Events26 weeks
Visual Acuity26 weeks
Slit Lamp and Fundoscopy26 weeks

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