Pharmacokinetic Study to Determine Time to Steady-state

December 10, 2020 updated by: Clarus Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Alabama Clinical Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Testosterone Undecanoate
Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.
Drug: Testosterone undecanoate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum T Concentration at Steady State
Time Frame: pre-dose on Days 1, 3, 5, 6, and 7
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
Serum T Concentration at Steady-State
Time Frame: pre-dose on Days 10, 14, 17, 21, 24, 27, and 28
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clarus Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

May 29, 2009

First Posted (ESTIMATE)

June 2, 2009

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAR-09009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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