Oral Testosterone for the Treatment of Hypogonadism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TesoRx Pharma, LLC
ClinicalTrials.gov Identifier:
NCT01717768
First received: October 25, 2012
Last updated: June 27, 2014
Last verified: June 2014
  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:


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: 140
Study Start Date: October 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Principal Investigator: John Kowalczyk, DO, FACOS Urology Group of Southern California
  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: June 27, 2014
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 September 14, 2014