Pharmacokinetic Study to Determine Time to Steady-state

Phase 2

Completed

• Conditions: Primary Hypogonadism; Male Hypogonadism; Secondary Hypogonadism
• Interventions: Drug: Testosterone undecanoate

• Registration Number: NCT00911586
• Lead Sponsor: Clarus Therapeutics, Inc.

Brief 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.

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 Timeline

• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-05-29
• Study First Posted: 2009-06-02
• Study Start: 2009-07
• Primary Completion: 2009-09
• Study Completion: 2010-01
• Disposition First Submitted: 2010-08-17
• Disposition First Submitted QC: 2010-08-17
• Disposition First Posted: 2010-08-19
• Results First Submitted: 2020-08-31
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-10
• Last Update Submitted: 2020-12-10
• Results First Posted: 2020-12-11
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Testosterone Undecanoate	Testosterone undecanoate	Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.

Primary Outcome Measures

Name	Time	Method
Serum T Concentration at Steady State	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.
Serum T Concentration at Steady-State	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.

Trial Locations

Locations (1)

Alabama Clinical Therapeutics; 🇺🇸 Birmingham, Alabama, United States