To Evaluate Fertility in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone - Full Text View

Sponsor:	Repros Therapeutics Inc.
Information provided by:	Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT00706719

Purpose

To determine if Androxal® can correct the central defect in men who have AIHH that blocks their ability to produce the hormones (LH and FSH) which stimulate testosterone production and sertoli cell number, thereby restoring sperm count. Twelve subjects per group will be randomized to daily treatments of Androxal® or topical testosterone Testim ® for six months. These men must have been previously treated with exogenous testosterone.

Condition	Intervention	Phase
Infertility in Men Secondary Hypogonadism	Drug: enclomiphene citrate Drug: topical testosterone gel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label, Fixed Dose, Active-Control, Multi-Center Phase IIB Study to Evaluate Fertility in Men With Secondary Hypogonadism, Comparing Androxal® to a Topical Testosterone in Men Previously Treated With Topical Testosterone.

Resource links provided by NLM:

MedlinePlus related topics: Infertility

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Enclomiphene Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:

Change in semen volume, sperm count and sperm motility from baseline in men treated with Androxal® [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in semen volume, sperm count and sperm motility in men treated with Androxal® versus men treated with Testim® [ Time Frame: Months 3 and 6. ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	June 2008
Study Completion Date:	August 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 1 capsule daily of 25 mg of Androxal®	Drug: enclomiphene citrate capsules, 25 mg, 1 capsule daily for 6 months
B: Active Comparator Testim® 1% Gel	Drug: topical testosterone gel gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months

Eligibility

Ages Eligible for Study:	21 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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 PSA>3.6 or clinical suspicion of current prostate disease.
Men with a hematocrit in excess of 50 % or hemoglobin >17 g/dl

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706719

Locations

United States, New York
University Urology Associates
New York, New York, United States, 10016
MAZE Labs
Purchase, New York, United States, 10577

Sponsors and Collaborators

Repros Therapeutics Inc.

Investigators

Study Director:

Ronald Wiehle, PhD

Repros Therapeutics Inc.

More Information

No publications provided

Responsible Party:	Repros Therapeutics Inc. ( Ronald Wiehle, PhD )
Study ID Numbers:	ZA-201
Study First Received:	June 25, 2008
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00706719 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:

Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH)
Secondary hypogonadism
Semen volume
Sperm count
Sperm motility

Additional relevant MeSH terms:

Infertility
Gonadal Disorders
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Clomiphene
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Hormones
Genital Diseases, Female
Estrogen Receptor Modulators
Neoplastic Processes
Pathologic Processes
Therapeutic Uses

Neoplasm Metastasis
Estrogen Antagonists
Antineoplastic Agents, Hormonal
Endocrine System Diseases
Methyltestosterone
Genital Diseases, Male
Pharmacologic Actions
Testosterone 17 beta-cypionate
Testosterone
Neoplasms
Anabolic Agents
Hypogonadism
Fertility Agents, Female
Fertility Agents
Androgens

ClinicalTrials.gov processed this record on February 08, 2010