Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

Secondary Hypogonadism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270841
• Other study ID #: ZA-203
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2011
• Last updated: June 27, 2014
• Start date: January 2011
• Est. completion date: December 2011

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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 65 Years

Eligibility

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, 5a-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Neoplasm Metastasis
• Secondary Hypogonadism

Intervention

Drug:
• Placebo
Placebo capsule 1x daily for 3 months
• topical testosterone
testosterone gel applied 1x daily for 3 months
• Androxal
Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Locations

Country	Name	City	State
United States	Discovery Clinical Trials	Austin	Texas
United States	Research Across America	Carrollton	Texas
United States	Paradigm Clinical Inc.	Garden Grove	California
United States	Weill Cornell Medical College and Smith Institute	Great Neck	New York
United States	Centex Research	Houston	Texas
United States	Endocrine and Psychiatry Center	Houston	Texas
United States	Texas Urology Specialist	Houston	Texas
United States	Protenium Clinical Research	Hurst	Texas
United States	R/D Clinical Research	Lake Jackson	Texas
United States	Affiliated Clinical Research	Las Vegas	Nevada
United States	Affiliated Clinical Research Inc.	Las Vegas	Nevada
United States	Jed Kaminetsky	New york	New York
United States	Natan Bar-Chama	New York	New York
United States	Michael A Werner	Purchase	New York
United States	Northern California Research Corp	Sacramento	California
United States	Cetero Research	San Antonio	Texas
United States	Medical Center for Clinical Research	San Diego	California
United States	Los Angeles Biomedical Research Institute	Torrance	California

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 in Total Morning Testosterone	Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim	3 months	No
Secondary	Change in Luteinizing Hormone Levels	Changes in values from baseline in LH at month 3	3 months	No
Secondary	Change in FSH After 3 Months of Treatment		3 months	No
Secondary	Reproductive Safety	Change from baseline in sperm concentration	3 months	Yes

External Links

•   Sponsor website
•   Website