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Oral Testosterone for the Treatment of Hypogonadism in Males

NCT ID: NCT02222558

Last Updated: 2016-05-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypogonadism

Keywords

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hypogonadism Gonadal Disorders Endocrine System Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Androgens Hormones Hormones, Hormone Substitutes, Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Anabolic Agents dihydrotestosterone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Period 1: Single Dose

Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

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

Period 2: Two Times Daily Dosing 90 mg

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

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

Period 3: Two Times Daily Dosing 120 mg

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

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

Period 3: Three Times Daily Dosing 90 mg

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

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

Period 3: Two Times Daily Dosing 180 mg

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

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

Period 3: Three Times Daily Dosing 120 mg

Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.

Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment.

Group Type EXPERIMENTAL

TSX-002

Intervention Type DRUG

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

Interventions

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TSX-002

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

Intervention Type DRUG

Other Intervention Names

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Testosterone

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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TesoRx Pharma, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irwin Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

San Diego Sexual Medicine

Locations

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San Diego Sexual Medicine

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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TT-006

Identifier Type: -

Identifier Source: org_study_id