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

Repros Therapeutics

Status and phase: Completed; Phase 3

Conditions: Secondary Hypogonadism

Treatments: Drug: Androxal

Study type: Interventional

Funder types: Industry

Identifiers

NCT01739582

ZA-301EXT

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Androxal

Experimental group

Description:

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.

Treatment:

Drug: Androxal