DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Oral Testosterone for the Treatment of Hypogonadism in Males

Information source: TesoRx Pharma, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism

Intervention: TSX-002 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: TesoRx Pharma, LLC

Official(s) and/or principal investigator(s):
Irwin Goldstein, MD, Principal Investigator, Affiliation: San Diego Sexual Medicine


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.

Clinical Details

Official title: A Phase 2B Study to Determine the Dose Response Pharmacokinetics of TSX-002 (Testosterone) in Hypogonadal Males

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Serum Testosterone

Secondary outcome:

Serum dihydrotestosterone (DHT)

Safety of TSX-002

Detailed description: The purpose of this study is to evaluate the pharmacokinetic (PK) parameters of testosterone after administration of TSX-002 (easy to swallow testosterone capsules) to hypogonadal men. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the PK parameters of the testosterone metabolite, dihydrotestosterone (DHT), as well as the safety and tolerability of TSX-002. The study consists of three (3) periods, for which TSX-002 will be taken orally at various doses. Study duration is approximately 9 weeks.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Male.


Inclusion Criteria:

- Symptomatic hypogonadal male subjects (Testosterone > 100 and <300 ng/dL, two

separate 10 am samples one week apart),

- 18-70 years old,

- Willing and able to provide informed consent and to participate in all 3 periods of

the study.

- BMI < 35 kg/m2.

Exclusion Criteria:

- Malabsorption conditions (e. g. history of cholecystectomy, Inflammatory Bowel

Disease, Pancreatitis, Celiac disease, Sprue, Dumping syndrome, Bariatric surgery; Short bowel syndrome, Lactose intolerance);

- Alcoholics or substance abuse;

- Gastroparesis; IPSS (International Prostate Symptom score) > 19; PSA

(prostate-specific antigen)> 4 ng/ml;

- Congestive Heart Failure, uncontrolled (NYHC >1);

- Uncontrolled sleep apnea;

- Topical or injectable testosterone replacement therapy (any kind including

dehydroepiandrosterone (DHEA) and nutritional supplements) within past 4 weeks;

- Testopel excluded if within 2 years;

- Aveed excluded if within past 6 months;

- Hematocrit > 50.

Locations and Contacts

San Diego Sexual Medicine, San Diego, California 92120, United States
Additional Information

Starting date: September 2014
Last updated: May 21, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017