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

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

MedlinePlus related topics:

Infertility

Drug Information available for:

Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Citric acid Sodium Citrate Enclomiphene

U.S. FDA Resources

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.

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
Estimated Study Completion Date:	September 2009
Estimated 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

Contacts


Contact: Ronald Wiehle, PhD	281-719-3400	administrator@reprosrx.com

Locations


United States, New York
	University Urology Associates	Recruiting
	New York, New York, United States, 10016
	Contact: Betsy Moclair 212-686-9015 bmoclair@universityurology.com
	Principal Investigator: Jed Kaminetsky, MD
	MAZE Labs	Recruiting
	Purchase, New York, United States, 10577
	Contact: Tammy Facciolo 914-997-4100 tammy@mazelabs.com
	Principal Investigator: Michael Werner, MD

Sponsors and Collaborators

Repros Therapeutics Inc.

Investigators


Study Director:	Ronald Wiehle, PhD	Repros Therapeutics Inc.

More Information

Responsible Party:	Repros Therapeutics Inc. ( Ronald Wiehle, PhD )
Study ID Numbers:	ZA-201
First Received:	June 25, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00706719
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

Study placed in the following topic categories:

Infertility

Gonadal Disorders

Citric Acid

Clomiphene

Endocrine System Diseases

Kallmann Syndrome

Septo-optic dysplasia

Methyltestosterone

Genital Diseases, Male

Testosterone 17 beta-cypionate

Genital Diseases, Female

Testosterone

Hypogonadism

Neoplasm Metastasis

Spastic paraplegia epilepsy mental retardation

Endocrinopathy

Septo-Optic Dysplasia

Additional relevant MeSH terms:

Estrogen Antagonists

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Reproductive Control Agents

Selective Estrogen Receptor Modulators

Hormones

Pharmacologic Actions

Estrogen Receptor Modulators

Neoplastic Processes

Neoplasms

Anabolic Agents

Pathologic Processes

Fertility Agents, Female

Therapeutic Uses

Fertility Agents

Androgens

ClinicalTrials.gov processed this record on October 24, 2008

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