Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism (ZA-003Ext)

Repros Therapeutics

Status and phase: Completed; Phase 3

Conditions: Secondary Hypogonadism

Treatments: Drug: Androxal

Study type: Interventional

Funder types: Industry

Identifiers

NCT01067365

ZA-003 Extension Study

Details and patient eligibility

About

Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.

Full description

The objectives of this study were to evaluate the safety and efficacy of Androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed ZA-003.

Enrollment: 104 patients

Sex: Male

Ages: 18 to 68 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Total serum testosterone concentrations < 300 ng/dL at baseline

Exclusion criteria

• Presence or history of prostate cancer
• Elevated PSA > 3.5 ng/mL

Additional inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

104 participants in 2 patient groups

12.5 mg Androxal

Experimental group

Description:

12.5 mg Androxal daily

Treatment:

Drug: Androxal

Drug: Androxal

25 mg Androxal

Experimental group

Description:

25 mg Androxal daily

Treatment:

Drug: Androxal

Drug: Androxal