Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

Secondary Hypogonadism Clinical Trial

Official title:

An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534208
• Other study ID #: ZA-300
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2012
• Last updated: June 27, 2014
• Start date: May 2012
• Est. completion date: October 2013

Study information

• Verified date: June 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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, 5a-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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Neoplasm Metastasis
• Secondary Hypogonadism

Intervention

Drug:
• Androxal
Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Locations

Country	Name	City	State
United States	Meridien Research	Bradenton	Florida
United States	Catalina Research Institute	Chino	California
United States	Florida Fertility Institute	Clearwater	Florida
United States	Clinical Research Advantage	Colorado Springs	Colorado
United States	Clinical Research Advantage	Colorado Springs	Colorado
United States	Lone Peak Family Medicine	Draper	Utah
United States	Therafirst Medical Center	Fort Lauderdale	Florida
United States	SC Clinical Research	Garden Grove	California
United States	Clinical Research Advantage	Glendale	Arizona
United States	Advances in Health	Houston	Texas
United States	East Coast Institute for Clinical Research	Jacksonville	Florida
United States	East Coast Institute for Research	Jacksonville	Florida
United States	East Coast Institute for Research	Jacksonville	Florida
United States	South Orange County Endocrinology	Laguna Hills	California
United States	Premier Urology Associates	Lawrenceville	New Jersey
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Anthony Mills, MD	Los Angeles	California
United States	Well Pharma Medical Research	Miami	Florida
United States	Cetero Research	Miami Gardens	Florida
United States	Clinical Research Advantage	Phoenix	Arizona
United States	DMI Research	Pinellas Park	Florida
United States	Ebon Bourne, MD	Plantation	Florida
United States	Granger Medical Clin ic	Riverton	Utah
United States	San Diego Sexual Medicine	San Diego	California
United States	SD Uro-Research	San Diego	California
United States	SC Clinical Research	Santa Ana	California
United States	Meridien Research	St. Petersburg	Florida
United States	Breco Research	Sugar Land	Texas
United States	West Coast Clinical Research	Tarzana	California
United States	IRC Clinics	Towson	Maryland
United States	Center of Reproductive Medicine	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Total Morning Testosterone at 26 Weeks	Changes in values from baseline of total morning testosterone levels at Week 26	6 months	No
Primary	Change From Baseline in LH	Mean change from baseline in LH at end of treatment (26 weeks)	6 months	No
Primary	Absolute Values of Morning Testosterone	Absolute values of morning testosterone at end of treatment (26 weeks)	6 months	No
Primary	Mean Change From Baseline FPG	Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)	6 months	No
Primary	Change From Baseline in BMI	Mean change from baseline in BMI at end of treatment (26 weeks)	6 months	No
Primary	Change From Baseline in FSH	Change from baseline in FSH at end of treatment (26 weeks)	6 months	No

External Links

•   Sponsor home page