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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Repros Therapeutics Inc.
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- 24 Hour Average and Maximum Testosterone Concentration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Androxal 6.25 mg
Androxal 6.25 mg/day
Intervention: Androxal (enclomiphene citrate) (Drug)
Androxal 12.5 mg
Androxal 12.5 mg/day
Intervention: Androxal (enclomiphene citrate) (Drug)
Androxal 25 mg
Androxal 25 mg/day
Intervention: Androxal (enclomiphene citrate) (Drug)
AndroGel
AndroGel 5G topical testosterone
Intervention: Testosterone (Drug)
Outcomes
Primary Outcomes
24 Hour Average and Maximum Testosterone Concentration
Time Frame: Baseline and Week 6
The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment. Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.
Secondary Outcomes
- Change in Leuteinizing Hormone (LH)(Baseline, Week 2, Week 4, Week 6)
- Change in Follicle Stimulating Hormone (FSH)(Baseline, Week 2, Week 4, Week 6)