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Pharmacokinetic Study to Determine Time to Steady-state

NCT ID: NCT00911586

Last Updated: 2020-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Male Hypogonadism Primary Hypogonadism Secondary Hypogonadism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Testosterone Undecanoate

Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.

Group Type EXPERIMENTAL

Testosterone undecanoate

Intervention Type DRUG

Interventions

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Testosterone undecanoate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Clarus Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory Flippo, MD

Role: PRINCIPAL_INVESTIGATOR

Alabama Clinical Therapeutics

Locations

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Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Yin AY, Htun M, Swerdloff RS, Diaz-Arjonilla M, Dudley RE, Faulkner S, Bross R, Leung A, Baravarian S, Hull L, Longstreth JA, Kulback S, Flippo G, Wang C. Reexamination of pharmacokinetics of oral testosterone undecanoate in hypogonadal men with a new self-emulsifying formulation. J Androl. 2012 Mar-Apr;33(2):190-201. doi: 10.2164/jandrol.111.013169. Epub 2011 Apr 7.

Reference Type DERIVED
PMID: 21474786 (View on PubMed)

Other Identifiers

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CLAR-09009

Identifier Type: -

Identifier Source: org_study_id