To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-08-31

Brief Summary

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The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.

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Detailed Description

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The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone. A maximum of twelve subjects per group were randomized to daily treatments of Androxal® or topical testosterone (Testim®) for six months. The protocol was later amended to include a treatment group who received Androxal after a 3 month wash out period.

Conditions

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Secondary Hypogonadism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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25 mg Androxal no wash out

1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period

Group Type EXPERIMENTAL

25 mg Androxal

Intervention Type DRUG

25 mg Androxal capsules, 1 capsule daily for 6 months

Testim 1% (topical testosterone)

Testim 1% Gel applied topically for 6 months

Group Type ACTIVE_COMPARATOR

Testim 1%

Intervention Type DRUG

Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months

25 mg Androxal wash out

1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone

Group Type EXPERIMENTAL

25 mg Androxal

Intervention Type DRUG

25 mg Androxal capsules, 1 capsule daily for 6 months

Interventions

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25 mg Androxal

25 mg Androxal capsules, 1 capsule daily for 6 months

Intervention Type DRUG

Testim 1%

Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months

Intervention Type DRUG

Other Intervention Names

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Enclomiphene citrate Topical testosterone

Eligibility Criteria

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Inclusion Criteria

* Healthy adult males between 21 and 60 years of age who have been diagnosed with AIHH.
* Subjects must have been treated with a topical testosterone replacement therapy (typically AndroGel® or Testim®) for at least 6 months at enrollment and for not more than 2 years.

Exclusion Criteria

* A history of idiopathic infertility due to primary hypogonadism, testicular failure, Kallmann's syndrome or any other infertility condition.
* Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile other than AIHH.
* Men with a history of, known, or suspected prostate disease not ruled out by a prostate biopsy, or a prostate specific antigen (PSA)\>3.6 or clinical suspicion of current prostate disease.
* Men with a hematocrit in excess of 50 % or hemoglobin \>17 g/dl

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No