Oral Testosterone for the Treatment of Hypogonadism in Males

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02222558
• Other study ID #: TT-006
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2014
• Last updated: May 21, 2015
• Start date: September 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: TesoRx Pharma, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hypogonadism

Intervention

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

Locations

Country	Name	City	State
United States	San Diego Sexual Medicine	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
TesoRx Pharma, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Testosterone	Total (actual measured) Testosterone, AUC(0-t) (where AUC is area under curve and t = 8, 12 and 24 hours), Cmax, Tmax, Cmin, tmin and Cmax to Cmin ratio.; Baseline Corrected Testosterone: kel, t½, CL/F, Vss/F, AUC(0-t(last)) and AUC(0-8).	Participants will be followed for the duration the study, an expected average of 9 weeks	No
Secondary	Serum dihydrotestosterone (DHT)	AUC, Cmax, Tmax, Cmax, Cmin, Cavg, Tmax, Tmin,	Participants will be followed for the duration the study, an expected average of 9 weeks	No
Secondary	Safety of TSX-002	clinically significant changes in laboratory parameters; physical examinations,; frequency and severity of adverse events; standard 12-lead ECG parameters and vital signs assessments; adverse events leading to discontinuation of study drug	Participants will be followed for the duration the study, an expected average of 9 weeks	Yes