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

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

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.

Study Overview

• Status: Completed
• Conditions: Secondary Hypogonadism
• Intervention / Treatment: Drug: Androxal (enclomiphene citrate); Drug: Testosterone

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77062
      • Centex Research
    • San Antonio, Texas, United States, 78229
      • Cetero Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Androxal 6.25 mg; Androxal 6.25 mg/day	Drug: Androxal (enclomiphene citrate); capsule oral 1X a day 6 weeks; Other Names: Androxal; low testosterone therapy
Experimental: Androxal 12.5 mg; Androxal 12.5 mg/day	Drug: Androxal (enclomiphene citrate); capsule oral 1X a day 6 weeks; Other Names: Androxal; low testosterone therapy
Experimental: Androxal 25 mg; Androxal 25 mg/day	Drug: Androxal (enclomiphene citrate); capsule oral 1X a day 6 weeks; Other Names: Androxal; low testosterone therapy
Active Comparator: AndroGel; AndroGel 5G topical testosterone	Drug: Testosterone; topical gel 1X a day 6 weeks; Other Names: topical testosterone; testosterone gel; exogenous testosterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Leuteinizing Hormone (LH)	Changes in morning LH after continuous dosing	Baseline, Week 2, Week 4, Week 6
Change in Follicle Stimulating Hormone (FSH)	Changes in morning FSH after continuous dosing	Baseline, Week 2, Week 4, Week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.	The Cmax for plasma concentration.	Week 6
Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.	The Tmax for plasma concentration.	Week 6
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

Collaborators and Investigators

• Sponsor: Repros Therapeutics Inc.
• Investigators: Principal Investigator: Jolene Berg, MD, Cetero Research, San Antonio

Publications and helpful links

Helpful Links

• Sponsor website
• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): July 1, 2011

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: August 21, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Gonadal Disorders; Neoplastic Processes; Neoplasm Metastasis; Hypogonadism; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Estrogen Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Androgens; Anabolic Agents; Testosterone; Clomiphene; Enclomiphene; Zuclomiphene; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: ZA-204