Back to results

Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

Primary Purpose

Hypogonadism

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Testosterone undecanoate

Testosterone enanthate

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring testosterone, male hypogonadism, low testosterone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
dgd Research, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Testosterone undecanoate

Testosterone enanthate

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Serum Dihydrotestosterone Cmax

Full Information

NCT ID

NCT02697188

First Posted

January 29, 2014

Last Updated

October 3, 2018

Sponsor

Clarus Therapeutics, Inc.

Collaborators

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02697188

Brief Title

Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clarus Therapeutics, Inc.

Collaborators

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadism

Keywords

testosterone, male hypogonadism, low testosterone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Testosterone undecanoate

Arm Type

Experimental

Arm Description

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)

Arm Title

Testosterone enanthate

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Testosterone undecanoate

Other Intervention Name(s)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Testosterone enanthate

Other Intervention Name(s)

Intervention Description

Single-day dose for 2 of 5 crossover periods

Primary Outcome Measure Information:

Title

Mean Serum Testosterone Cavg

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Mean Serum Dihydrotestosterone Cmax

Description

Time Frame

24 hours post-dose in each period

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald S Swerdloff, MD

Organizational Affiliation

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sherwyn Schwartz, MD

Organizational Affiliation

dgd Research, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

dgd Research, Inc

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

We'll reach out to this number within 24 hrs