Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

NCT02697188 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CLAR-07004
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.

Conditions

Hypogonadism

Keywords

testosterone; male hypogonadism; low testosterone

Outcome Measures

Primary Outcomes (1)

• Mean Serum Testosterone Cavg

  The objective of the study was to determine the single day serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU formulation) administered once- and twice-daily to hypogonadal men.

  Concentrations at -0.5, 0, 1, 2, 4, 8, 12, 13, 14, 16, 20, 24 and 34 hours post dose

Secondary Outcomes (1)

• Mean Serum Dihydrotestosterone Cmax

  24 hours post-dose in each period

Study Arms (2)

Testosterone undecanoate

EXPERIMENTAL

Period 2 - 200 mg T (as TU) QD Period 3 - 200 mg T (as TU) BID (100 mg/dose) Period 4 - 400 mg T (as TU) BID (200 mg/dose)

Drug: Testosterone undecanoate

Testosterone enanthate

ACTIVE COMPARATOR

Period 1 - 400 mg T (as TE) QD Period 5 - 800 mg T (as TE) BID (400 mg/dose)

Drug: Testosterone enanthate

Interventions

Testosterone undecanoate DRUG

Single-day dose as QD or BID for 3 of 5 crossover periods

Also known as: TU

Testosterone undecanoate

Testosterone enanthate DRUG

Single-day dose for 2 of 5 crossover periods

Also known as: TE

Testosterone enanthate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, ages 18 to 65 Serum total testosterone less than or equal to 250 ng/dL Naive to androgen replacement therapy Subject must be on stable doses of thyroid or adrenal replacement hormones for at least 14 days prior to enrollment

You may not qualify if:

• Significant intercurrent disease of any type, in particular, liver, kidney or heart disease, uncontrolled diabetes mellitus or psychiatric illness. Patients with treated hyperlipidemia will not be excluded provided they have been stable on their lipid-lowering mediation for at least three months. For non-insulin dependent diabetic subjects, HbA1c\>9%.
• Abnormal prostate digital rectal examination, elevated PSA (serum PSA \>4ng/mL), AUA Sympton Score greater than or equal to 15 points, and a history or prostate cancer.
• Serum transaminases \>2X upper limit of normal (ULN) or serum bilirubin \>2.0 mg/dL.
• History of severe or multiple allergies, severe adverse drug reaction or leucopenia. Known hypersensitivity to lidocaine or all surgical dressings.
• History of abnormal bleeding tendencies. Oral, topical, or buccal T therapy within the previous week, or intramuscular T injection within the previous 4 week.
• Use of dietary supplements that may increase serum T, such as androstenedione or DHEA, within the previous 4 weeks.
• Know malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile acid-binding resins, colestipol, fibric acid derivatives, gemfibrozil, and probucol.
• Smokers who are unable to refrain from smoking during confinement periods. History of, or current evidence of, abuse of alcohol or any drug substance. Poor compliers or those unlikely to attend. Receipt of any drug as part of a research study within 30 days of inital dose administration in this study.
• Blood donation (usually 550 mL) within the 12-week period before the initial study dose.
• Hematocrit less than 35%. Known clinical polycythemia or hematocrit greater than 50%. Current use of paroxetine and clomipramine, antiandrogens, estrogens, p450 enzyme inducers, or barbiturates.
• History of sleep apnea.

Sponsors & Collaborators

• Clarus Therapeutics, Inc.: lead
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator

Study Sites (2)

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Los Angeles, California, 90502, United States

Location

dgd Research, Inc

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Hypogonadism; Eunuchism

Interventions

testosterone undecanoate; testosterone enanthate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Theodore Danoff, MD, PhD
• Organization: Clarus Therapeutics

tdanoff@clarustherapeutics.com

847-562-4300

Study Officials

• Ronald S Swerdloff, MD

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

• Sherwyn Schwartz, MD

  dgd Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: March 3, 2016
• Study Start: November 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: November 1, 2018
• Results First Posted: November 1, 2018

Record last verified: 2018-10

Locations

US (2)