Clinical trial NCT01270841: Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
Official title: A Randomized, Double Blind, Placebo and Active Controlled, Parallel, Multi-Center Phase IIb Study to Evaluate Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondary Hypogonadism
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-05
Enrollment: 83
Sex: MALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.

Detailed description: This study is a phase IIb, 4 arm study with three month active dosing period. Three of the four treatment groups will be randomized to either Androxal or placebo in a double-blind fashion, and the fourth treatment group will receive open-label Testim. The doses of Androxal in the blinded portion of the study will be 12.5 mg and 25 mg, in capsule form.

Eligibility criteria: Inclusion Criteria:

* Healthy males between the ages of 21 and 65 years of age
* All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
* Previously or concurrently diagnosed as having secondary hypogonadism and confirmed morning testosterone \<250ng/dL (two assessments at least 10 days apart)
* Ability to complete the study in compliance with the protocol
* Ability to understand and provide written informed consent
* Agreement to use double barrier contraception if with a fertile female partner
* Agreement to provide a semen sample in the clinic

Exclusion Criteria:

* Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 6 months prior to study
* Use of spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
* Use of Clomid in the past year
* Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control will be allowed into the study
* A hematocrit \>50% or a hemoglobin \>17 g/dL
* Clinically significant abnormal findings on screening examination
* Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication
* Known hypersensitivity to Clomid
* Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade \> 2 based on 0-4 scale or any trace of posterior subcapsular cataract)
* Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study
* Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary)
* Current or history of breast cancer
* Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA\>3.6
* Presence or history of hyperprolactinemia with or without a tumor
* Chronic use of medications use such as glucocorticoids
* Subjects with cystic fibrosis (mutation of the CFTR gene)
* Subjects unable to provide a semen sample in the clinic
* Subject has a BMI \>36 kg/m2

Primary outcomes:
measure: Change in Total Morning Testosterone
timeFrame: 3 months
Secondary outcomes:
measure: Change in Luteinizing Hormone Levels
timeFrame: 3 months
measure: Change in FSH After 3 Months of Treatment
timeFrame: 3 months
measure: Reproductive Safety
timeFrame: 3 months
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Paradigm Clinical Inc.
state: California
city: Sacramento
country: United States
facility: Northern California Research Corp
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute
state: California
city: Las Vegas
country: United States
facility: Affiliated Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Affiliated Clinical Research Inc.
state: Nevada
city: Great Neck
country: United States
facility: Weill Cornell Medical College and Smith Institute
state: New York
city: New york
country: United States
facility: Jed Kaminetsky
state: New York
city: New York
country: United States
facility: Natan Bar-Chama
state: New York
city: Purchase
country: United States
facility: Michael A Werner
state: New York
city: Austin
country: United States
facility: Discovery Clinical Trials
state: Texas
city: Carrollton
country: United States
facility: Research Across America
state: Texas
city: Houston
country: United States
facility: Texas Urology Specialist
state: Texas
city: Houston
country: United States
facility: Centex Research
state: Texas
city: Houston
country: United States
facility: Endocrine and Psychiatry Center
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Cetero Research
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Larry Lipshultz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wiehle RD, Fontenot GK, Wike J, Hsu K, Nydell J, Lipshultz L; ZA-203 Clinical Study Group. Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone. Fertil Steril. 2014 Sep;102(3):720-7. doi: 10.1016/j.fertnstert.2014.06.004. Epub 2014 Jul 17.