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testosterone

Phase 1

Skin Androgenization | Small molecule | Dermatology |Merck & Company, Inc.|Last Updated: Sep 4, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

testosterone · 1 trial · 1 indication

Phase 1 1
NCT00969163A Study to Investigate Biomarkers of Skin Androgenization Following Testosterone Administration (0000-015)(COMPLETED).Skin Androgenization
COMPLETED30 Analytics
PHASE1COMPLETED
A Study to Investigate Biomarkers of Skin Androgenization Following Testosterone Administration (0000-015)(COMPLETED).
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Study Endpoints

Primary Endpoints

serum free testosterone concentrations following multiple doses of AndroGel
6 weeks

Secondary Endpoints

mean percent change from baseline in sebum excretion
6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL2.5 mg testosterone gel
2EXPERIMENTAL300 ug testosterone gel
3PLACEBO_COMPARATORplacebo gel

Interventions

NameTypeDescription
testosterone gelDRUG300 ug or 2.5 mg transdermal testosterone gel daily for 6 weeks
Comparator: placeboDRUGtransdermal placebo gel for 6 weeks
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Eligibility Criteria

Age Range50 Years to 65 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Subject is at least 3 years postmenopausal * Subject is in good general health * Subject is willing to avoid excess alcohol or strenuous physical activity during the study Exclusion Criteria: * Subject has donated a unit of blood or has taken an investigational drug in anoth...

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Frequently asked questions about testosterone

What is low dose testosterone used for?

Low dose testosterone is an investigational small molecule being studied for skin androgenization and muscle anabolism. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 1 clinical development. It has not been approved by the FDA and remains investigational.

Who makes low dose testosterone?

Low dose testosterone is being developed by Merck & Company, Inc., which trades under the ticker MRK. The drug is currently in Phase 1 clinical trials for skin androgenization and muscle anabolism. It is an investigational small molecule and has not been approved for any use.

What phase is low dose testosterone in?

Low dose testosterone is in Phase 1 clinical development. It has completed two Phase 1 trials, one in muscle anabolism and one in skin androgenization. The drug is investigational and has not been approved by the FDA. Merck & Company, Inc. (MRK) is the developer.

What clinical trials is low dose testosterone in?

Low dose testosterone has completed two Phase 1 trials. NCT00812396 studied biomarkers of muscle anabolism in 30 healthy male volunteers. NCT00969163 studied biomarkers of skin androgenization in 30 healthy female volunteers. Both trials were placebo-controlled and completed.

Is low dose testosterone the same as testosterone?

Low dose testosterone is a form of testosterone being studied at low doses for specific indications. It is being developed by Merck & Company, Inc. (MRK) for skin androgenization and muscle anabolism. The drug is in Phase 1 trials and is not FDA approved.