Oral Testosterone for the Treatment of Hypogonadism in Males

TesoRx Pharma, LLC25 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypogonadism

Interventions

TSX-002DRUG

TSX-002 are capsules with testosterone as the active ingredient.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 (1)

San Diego Sexual Medicine

San Diego, California, United States

Outcomes

Primary Outcomes

Percentage of Responders

Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL.

Time frame: Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24

Data from ClinicalTrials.gov

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