A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203

Repros Therapeutics Inc.48 enrolled

Overview

The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypogonadism Low Testosterone

Interventions

Androxal (enclomiphene citrate)DRUG

capsules oral 1x a day 1 year

Testim (topical testosterone)DRUG

topical 1 tube 1x a day 1 year

Eligibility

Sex: MALEMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Successful completion of ZA-203 * Ability to understand and provide written informed consent * Agreement to use a condom, and with a fertile female partner, another form of contraception * Agreement to provide semen samples in the clinic Exclusion Criteria: * Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study

Locations (8)

Unnamed facility

Garden Grove, California, United States

Unnamed facility

Sacramento, California, United States

Unnamed facility

San Diego, California, United States

Unnamed facility

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

Change in testosterone comparing Androxal to Testim

Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim

Time frame: 1 year

Secondary Outcomes

Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)

Values of follicle stimulating hormone (FSH) and leuteinizing hormone (LH) at each visit comparing Androxal 12.5 and 25 mg to Testim

Time frame: 1 year

Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)

Reproductive safety will be assessed by changes in values from baseline of semen volume, and sperm concentration, total count, morphology and motility at baseline (Visit 1), month 4, 6 and 12 comparing Androxal 12.5 and 25 mg to Testim

Time frame: 1 year

Data from ClinicalTrials.gov

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