Oral Testosterone for the Treatment of Hypogonadism - Full Text View

Purpose

Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.

The purpose of this study is to evaluate the ability of TSX-002, which is testosterone provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within the normal range in hypogonadal men. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of TSX-002, which will be taken orally twice per day for 15 days.

Condition	Intervention	Phase
Hypogonadism	Drug: TSX-002	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2, Randomized, Double-blind, Dose Response Study of Oral Testosterone in Subjects With Hypogonadism

Resource links provided by NLM:

MedlinePlus related topics: Anabolic Steroids Endocrine Diseases

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate

U.S. FDA Resources

Further study details as provided by TesoRx Pharma, LLC:

Primary Outcome Measures:

Total serum testosterone [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Proportion of subject achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of BID treatment with TSX-002

Secondary Outcome Measures:

Proportion of subjects with total serum testosterone levels above normal range [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Safety of TSX-002 [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
- frequency and severity of adverse events
- clinically significant changes in laboratory parameters
- vitals and electrocardiograms (ECGs)
- physical examinations
- adverse events leading to discontinuation of study drug

Enrollment:	34
Study Start Date:	October 2012
Estimated Study Completion Date:	March 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: TSX-002 (oral testosterone) 120 mg Oral administration of TSX-002 120 mg BID for 15 days	Drug: TSX-002 TSX-002 are capsules with testosterone as the active ingredient. Other Name: Testosterone
Experimental: TSX-002 (oral testosterone) 240 mg Oral administration of TSX-002 240 mg BID for 15 days	Drug: TSX-002 TSX-002 are capsules with testosterone as the active ingredient. Other Name: Testosterone

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Prior documentation of a diagnosis of hypogonadism as evidenced by a screening serum testosterone < 300 ng/dL (based on the average of 2 morning samples taken at least 1 week apart)
Men over the age of 18 years with a body mass index (BMI) < 39.0 kg/m2 and weighing ≥ 55 kg
Hemoglobin levels at screening and baseline > 12.5 g/dL
Testosterone treatment not contraindicated
No evidence of suspected reversible hypogonadism
Willing to abstain from current treatment for hypogonadism in accordance with approved labeling to facilitate an appropriate washout period before study participation (for nondepot formulations of testosterone only)
Understands the requirements of the study and voluntarily consents to participate in the study

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717768

Locations

United States, California
Urology Group of Southern California
Los Angeles, California, United States, 90048

Sponsors and Collaborators

TesoRx Pharma, LLC

Investigators

Study Director:

Ahmed Hamdy, MD

TesoRx Pharma, LLC

More Information

No publications provided

Responsible Party:	TesoRx Pharma, LLC
ClinicalTrials.gov Identifier:	NCT01717768 History of Changes
Other Study ID Numbers:	TT-002
Study First Received:	October 25, 2012
Last Updated:	February 28, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by TesoRx Pharma, LLC:

hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone

Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anabolic Agents

Additional relevant MeSH terms:

Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Hormones, Hormone Substitutes, and Hormone Antagonists

Physiological Effects of Drugs
Androgens
Hormones
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 21, 2013