NCT02222558

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 30, 2016

Completed
Last Updated

May 30, 2016

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

August 18, 2014

Results QC Date

March 16, 2016

Last Update Submit

April 21, 2016

Conditions

Hypogonadism

Keywords

hypogonadismGonadal DisordersEndocrine System DiseasesTestosteroneTestosterone enanthateTestosterone undecanoateTestosterone 17 beta-cypionateMethyltestosteroneAndrogensHormonesHormones,Hormone Substitutes,Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsTherapeutic UsesAnabolic Agentsdihydrotestosterone

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

Study Arms (6)

Period 1: Single Dose

EXPERIMENTAL

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.

Drug: TSX-002

Period 2: Two Times Daily Dosing 90 mg

EXPERIMENTAL

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

Drug: TSX-002

Period 3: Two Times Daily Dosing 120 mg

EXPERIMENTAL

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.

Drug: TSX-002

Period 3: Three Times Daily Dosing 90 mg

EXPERIMENTAL

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.

Drug: TSX-002

Period 3: Two Times Daily Dosing 180 mg

EXPERIMENTAL

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.

Drug: TSX-002

Period 3: Three Times Daily Dosing 120 mg

EXPERIMENTAL

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.

Drug: TSX-002

Interventions

TSX-002DRUG

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

Also known as: Testosterone
Period 1: Single DosePeriod 2: Two Times Daily Dosing 90 mgPeriod 3: Three Times Daily Dosing 120 mgPeriod 3: Three Times Daily Dosing 90 mgPeriod 3: Two Times Daily Dosing 120 mgPeriod 3: Two Times Daily Dosing 180 mg

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic hypogonadal male subjects (Testosterone \> 100 and \<300 ng/dL, two separate 10 am samples one week apart),
  • years old,
  • Willing and able to provide informed consent and to participate in all 3 periods of the study.
  • BMI \< 35 kg/m2.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

MeSH Terms

Conditions

HypogonadismGonadal DisordersEndocrine System Diseases

Interventions

Testosterone

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Michael Oefelein, MD, Chief Medical Officer
Organization
TesoRx Pharma, LLC
karl@tesorx.com
909-595-0500

Study Officials

  • Irwin Goldstein, MD

    San Diego Sexual Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 21, 2014

Study Start

September 1, 2014

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

May 30, 2016

Results First Posted

May 30, 2016

Record last verified: 2016-04

Locations

US(1)