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NCT00911586 Clinical Trial

Pharmacokinetic Study to Determine Time to Steady-state

Secondary Hypogonadism Clinical Trial

Official title:
Pharmacokinetic Study to Determine Time to Steady-state of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00911586
Other study ID # CLAR-09009
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 2009
Est. completion date January 2010

Study information
Verified date December 2020
Source Clarus Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.

Description:

Serum testosterone levels will be obtained in hypogonadal (serum testosterone <300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-state is reached.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date January 2010
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Male, age 18-75 - Morning serum testosterone (T) <300 ng/dL on two occasions - Naive to androgen-replacement therapy or willing to wash-out from current T therapy Exclusion Criteria: - Significant intercurrent disease - Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history of prostate cancer. - Serum transaminases >2 times upper limit of normal - Serum bilirubin >2.0 mg/dL - Hematocrit <35% or >50% - BMI >36 - Untreated, obstructive sleep apnea.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Testosterone undecanoate

Locations
Country Name City State
United States Alabama Clinical Therapeutics Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
Clarus Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum T Concentration at Steady State Serum T at steady state by evaluating the day-to-day changes in pre-dose concentrations on Days 1, 3, 5, 6, and 7 of treatment. pre-dose on Days 1, 3, 5, 6, and 7
Primary Serum T Concentration at Steady-State Serum T at steady-state by evaluating the day-to-day changes in pre-dose concentrations on Days 10, 14, 17, 21, 24, 27, and 28 of treatment. pre-dose on Days 10, 14, 17, 21, 24, 27, and 28
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Completed NCT01993212 - A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62% Phase 3
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