Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

Hypogonadism Clinical Trial

Official title:

Phase IIa, Pilot, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697188
• Other study ID #: CLAR-07004
• Status: Completed
• Phase: Phase 2
• Start date: November 2007
• Est. completion date: April 2008

Study information

• Verified date: October 2018
• Source: Clarus Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Five period cross-over study in which subjects received a single day of dosing in each period. Dosing was either QD or BID with one of two T esters (T-enanthate (TE) or T-undecanoate (TU)). Dosing was within 5 minutes of meals (breakfast and for BID dosing dinner). There was a minimum of a 5-day washout between periods. Subjects were hypogonadal men.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testosterone undecanoate
Single-day dose as QD or BID for 3 of 5 crossover periods
• Testosterone enanthate
Single-day dose for 2 of 5 crossover periods

Locations

Country	Name	City	State
United States	Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center	Los Angeles	California
United States	dgd Research, Inc	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Clarus Therapeutics, Inc.	Los Angeles Biomedical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Serum Dihydrotestosterone Cmax	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.	24 hours post-dose in each period