Clinical trial NCT01534208: Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Official title: An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Hypogonadism
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-16
Enrollment: 499
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.

Detailed description: This study is a phase III, open label safety study with a six month active dosing period. All subjects will be started at 12.5 mg Androxal and titrated to 25 mg if needed. Safety will be assessed by physical and visual acuity exams, slit lamp eye exams, clinical laboratory tests and adverse event reporting.

Eligibility criteria: Inclusion Criteria:

1. Secondary hypogonadal males between the ages of 18 and 65
2. Men currently using topical testosterone products should wash-out for at least 7 days before Visit 1.
3. All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
4. Previously or concurrently diagnosed as having secondary hypogonadism and confirmed with morning testosterone level \< 350 ng/dL for men age \< 55 and \< 300ng/dl for men age 55-65
5. LH \< 15mIU/mL (at Visit 1 only)
6. Ability to complete the study in compliance with the protocol
7. Ability to understand and provide written informed consent.

Exclusion Criteria:

1. Use of an injectable pelleted testosterone within 6 months prior to study (men currently on topical testosterone products may be enrolled in the study after a 7-day washout period).
2. Use testosterone injection, spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
3. Use of Clomid in the past year
4. Uncontrolled hypertension based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study.
5. A hematocrit ≥ 51% or a hemoglobin ≥ 17 g/dL
6. Clinically significant abnormal findings on screening examination, based on the Investigator's assessment.
7. 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.
8. Known hypersensitivity to Clomid
9. Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade \> 2 based on 0-4 scale or any trace of posterior subcapsular cataract)
10. 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
11. Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, or tumors of the pituitary)
12. Current or history of breast cancer
13. Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA \> 3.6
14. Presence or history of known hyperprolactinemia with or without a tumor
15. Chronic use of medications use such as glucocorticoids
16. Chronic use of narcotics
17. Subjects know to be positive for HIV
18. End stage renal disease
19. Subjects with cystic fibrosis (mutation of the CFTR gene)
20. Enrollment in a previous Androxal study

Primary outcomes:
measure: Change From Baseline in Total Morning Testosterone at 26 Weeks
timeFrame: 6 months
measure: Change From Baseline in LH
timeFrame: 6 months
measure: Absolute Values of Morning Testosterone
timeFrame: 6 months
measure: Mean Change From Baseline FPG
timeFrame: 6 months
measure: Change From Baseline in BMI
timeFrame: 6 months
measure: Change From Baseline in FSH
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Clinical Research Advantage
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Advantage
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Chino
country: United States
facility: Catalina Research Institute
state: California
city: Garden Grove
country: United States
facility: SC Clinical Research
state: California
city: Laguna Hills
country: United States
facility: South Orange County Endocrinology
state: California
city: Los Angeles
country: United States
facility: Anthony Mills, MD
state: California
city: San Diego
country: United States
facility: SD Uro-Research
state: California
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
city: Santa Ana
country: United States
facility: SC Clinical Research
state: California
city: Tarzana
country: United States
facility: West Coast Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Clinical Research Advantage
state: Colorado
city: Colorado Springs
country: United States
facility: Clinical Research Advantage
state: Colorado
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Clearwater
country: United States
facility: Florida Fertility Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: Therafirst Medical Center
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research
state: Florida
city: Miami Gardens
country: United States
facility: Cetero Research
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research
state: Florida
city: Plantation
country: United States
facility: Ebon Bourne, MD
state: Florida
city: St. Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Towson
country: United States
facility: IRC Clinics
state: Maryland
city: Lawrenceville
country: United States
facility: Premier Urology Associates
state: New Jersey
city: Houston
country: United States
facility: Advances in Health
state: Texas
city: Sugar Land
country: United States
facility: Breco Research
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicine
state: Texas
city: Draper
country: United States
facility: Lone Peak Family Medicine
state: Utah
city: Riverton
country: United States
facility: Granger Medical Clin ic
state: Utah
Study officials:
affiliation: Repros Therapeutics Inc.
name: Joseph S Podolski
role: STUDY_CHAIR
References: