The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

Secondary Hypogonadism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386606
• Other study ID #: ZA-204
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2011
• Last updated: August 21, 2015
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: August 2015
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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, 5a-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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Neoplasm Metastasis
• Secondary Hypogonadism

Intervention

Drug:
• Androxal (enclomiphene citrate)
capsule oral 1X a day 6 weeks
• Testosterone
topical gel 1X a day 6 weeks

Locations

Country	Name	City	State
United States	Centex Research	Houston	Texas
United States	Cetero Research	San Antonio	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
Other	Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.	The Cmax for plasma concentration.	Week 6	No
Other	Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.	The Tmax for plasma concentration.	Week 6	No
Other	Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.	The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24).	Week 6	No
Primary	24 Hour Average and Maximum Testosterone Concentration	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.	Baseline and Week 6	No
Secondary	Change in Leuteinizing Hormone (LH)	Changes in morning LH after continuous dosing	Baseline, Week 2, Week 4, Week 6	No
Secondary	Change in Follicle Stimulating Hormone (FSH)	Changes in morning FSH after continuous dosing	Baseline, Week 2, Week 4, Week 6	No

External Links

•   Link
•   Sponsor website