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

Purpose

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.

Condition	Intervention	Phase
Infertility in Men Secondary Hypogonadism	Drug: Androxal (enclomiphene citrate) Drug: topical testosterone gel	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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: Clomiphene citrate Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate Clomiphene Sodium citrate

U.S. FDA Resources

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:

Mean Sperm Concentration Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
Mean baseline values of total sperm concentration were measured for subjects in each of 3 treatment groups.
Mean Sperm Concentration 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Mean values of sperm concentration were measured for subjects in each of 3 treatment groups at 3 months
Mean Sperm Concentraion 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Mean values of sperm concentration were measured for subjects in each of 3 treatment groups at 6 months
Mean Total Sperm Count Basline [ Time Frame: baseline ] [ Designated as safety issue: No ]
Mean values of total sperm count were measured for subjects in each of 3 treatment groups at baseline
Mean Total Sperm Count 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Mean values of total sperm count were measured for subjects in each of 3 treatment groups at 3 months
Mean Total Sperm Count 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Mean values of total sperm count were measured for subjects in each of 3 treatment groups at 6 months
Mean Semen Volume Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
Mean values of semen volume were measured for subjects in each of 3 treatment groups at baseline
Mean Semen Volume 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Mean values of semen volume were measured for subjects in each of 3 treatment groups at 3 months
Mean Semen Volume 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Mean values of semen volume were measured for subjects in each of 3 treatment groups at 6 months

Secondary Outcome Measures:

Mean Follicle Stimulating Hormone(FSH) and Leutinizing Hormone(LH) Levels From Baseline to 3-months in Men Treated With Androxal® Versus Testim [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]

Enrollment:	17
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
Experimental: Androxal (enclomiphene citrate) no wash out 1 capsule daily for 6 months of 25 mg of Androxal® in men without a 3 month wash out period	Drug: Androxal (enclomiphene citrate) capsules, 25 mg, 1 capsule daily for 6 months
Active Comparator: Testim (topical testosterone) Testim® 1% Gel applied topically for 6 months	Drug: topical testosterone gel gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months
Experimental: Androxal (enclomiphene citrate) wash out 1 x 25 mg capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone	Drug: Androxal (enclomiphene citrate) capsules, 25 mg, 1 capsule 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 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

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:	Ronald Wiehle, PhD, Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT00706719 History of Changes
Other Study ID Numbers:	ZA-201
Study First Received:	June 25, 2008
Results First Received:	August 25, 2010
Last Updated:	June 29, 2011
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:

Hypogonadism
Infertility
Gonadal Disorders
Endocrine System Diseases
Genital Diseases, Male
Genital Diseases, Female
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Clomiphene
Androgens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on May 16, 2013