Clinical trial NCT01386606: The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
Official title: A Randomized, Single Blind, Multi-Center Phase II Study to Evaluate the Effect of Three Different Doses of Androxal and AndroGel on 24-Hour Luteinizing Hormone and Testosterone in Normal Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondary Hypogonadism
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-01
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (\<350 ng/dL)after 6 weeks of continuous dosing.

Detailed description: Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an eye exam. Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. A six month extension study will be available for all subjects completing the 6-week study.

Eligibility criteria: Inclusion Criteria:

* Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL.
* All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
* Ability to complete the study in compliance with the protocol
* Ability to understand and provide written informed consent
* Agreement to use a condom, and with a fertile female partner, another form of contraception.
* Agreement to provide a semen sample in the clinic

Exclusion Criteria:

* Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study
* Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
* Use of Clomid in the past year or during the study
* 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. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.
* A hematocrit ≥51 % 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
* 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)
* History of breast cancer
* History of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA \>3.6
* History of known hyperprolactinemia with or without a tumor
* Chronic use of medications use such as glucocorticoids
* Chronic use of narcotics
* Subjects known to be positive for HIV
* Subjects with end stage renal disease
* Subjects with cystic fibrosis (mutation of the CFTR gene)
* Subjects unable to provide a semen sample in the clinic
* Subject has a BMI \>42 kg/m2

Primary outcomes:
measure: 24 Hour Average and Maximum Testosterone Concentration
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change in Leuteinizing Hormone (LH)
timeFrame: Baseline, Week 2, Week 4, Week 6
measure: Change in Follicle Stimulating Hormone (FSH)
timeFrame: Baseline, Week 2, Week 4, Week 6
Other outcomes:
measure: Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.
timeFrame: Week 6
measure: Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.
timeFrame: Week 6
measure: Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.
timeFrame: Week 6
Locations:
city: Houston
country: United States
facility: Centex Research
state: Texas
city: San Antonio
country: United States
facility: Cetero Research
state: Texas
Study officials:
affiliation: Cetero Research, San Antonio
name: Jolene Berg, MD
role: PRINCIPAL_INVESTIGATOR
References: