Expired Study
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Los Angeles, California 90502


Purpose:

The purpose of this pharmacokinetic study is to determine whether oral testosterone ester formulations can be used effectively to treat men with low testosterone.


Criteria:

Inclusion Criteria: - Male, ages 18-68 - Serum total testosterone less than or equal to 275 ng/dL Exclusion Criteria: - Significant intercurrent disease of any type, in particular, liver, kidney or heart disease, uncontrolled diabetes mellitus or psychiatric illness. - Abnormal prostate digital rectal examination, elevated PSA, AUA symptom score of >15, and/or history of prostate cancer. - Hematocrit of <35 or >50% - BMI >36 - Serum transaminases > 2 times upper limit of normal or serum bilirubin > 2.0 mg/dL


Study is Available At:


Original ID:

CLAR-08005


NCT ID:

NCT00695110


Secondary ID:


Study Acronym:


Brief Title:

Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men


Official Title:

Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

68 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Clarus Therapeutics, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

29


Enrollment Type:

Actual


Overall Contact Information

Official Name:Ronald S Swerdloff, M.D.
Principal Investigator
Los Angeles Biomedical Research Institute

Study Dates

Start Date:June 2008
Completion Date:August 2009
Completion Type:Actual
Primary Completion Date:December 2008
Primary Completion Type:Actual
Verification Date:August 2010
Last Changed Date:August 23, 2010
First Received Date:June 9, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Mean serum estradiol
Time Frame:7 day treatment cycles with washout
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Serum DHT AUC
Time Frame:7 day treatment cycles with washouts
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Serum DHT Tmax
Time Frame:7 day treatment cycles with washout
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Serum DHT Cavg
Time Frame:7 day treatment cycles with washouts
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Serum DHT Cmax
Time Frame:7 day treatment cycles with washouts
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Serum testosterone AUC
Time Frame:7 day treatment cycles with washouts
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Serum testosterone Tmax
Time Frame:7 day treatment cycles with washouts
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Serum testosterone Cavg
Time Frame:7 day treatment cycles with washouts
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Serum testosterone Cmax
Time Frame:7 day treatment cycles with washouts
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Testosterone undecanoate (TU)
Description:300 mg T equivalents BID for 7 days
Arm Name:1
Intervention Type:Drug
Name:TU + testosterone enanthate (TE)
Description:400 mg T equivalents BID for 7 days
Arm Name:2
Intervention Type:Drug
Name:Testosterone undecanoate (TU)
Description:200 mg T equivalents BID for 8 days; pharmacokinetics determined when oral TU administered with and without food.
Arm Name:3
Intervention Type:Drug
Name:TU + testosterone enanthate (TE)
Description:300 mg T equivalents BID for 7 days
Arm Name:4

Study Arms

Study Arm Type:Experimental
Arm Name:4
Description:TU + TE (300 mg T equivalents) BID for 7 days
Study Arm Type:Experimental
Arm Name:3
Description:TU (200 mg T equivalents) BID for 8 days
Study Arm Type:Experimental
Arm Name:2
Description:TU + testosterone enanthate (TE) (400 mg T equivalents) BID for 7 days
Study Arm Type:Experimental
Arm Name:1
Description:Testosterone undecanoate (TU) (300 mg T equivalents) BID for 7 days

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Clarus Therapeutics, Inc.
Agency Class:Other
Agency Type:Collaborator
Agency Name:Los Angeles Biomedical Research Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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