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Testosterone Enanthate

Phase 2

Male Hypogonadism | Small molecule | Endocrine |Merck & Company, Inc.|Last Updated: Oct 11, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Testosterone Enanthate · 1 trial · 4 indications

Phase 2 1
NCT004755015-Alpha Reductase and Anabolic Effects of TestosteroneMale Hypogonadism
COMPLETED60 Analytics
PHASE2COMPLETED
5-Alpha Reductase and Anabolic Effects of Testosterone
Male HypogonadismUnlock trial analytics

Study Endpoints

Primary Endpoints

1 Repetition Maximum (1-RM) Strength Testing
baseline, 3 months, 6 months, 9 months, 12 months

1-RM strength testing for 5 exercises will be performed using dynamic resistance exercise machines. Testing will be performed before treatment (baseline), at 3, 6, 9 and 12 months after treatment.

Secondary Endpoints

Grip Strength kg
baseline, 3 months, 6 months, 9 months, 12 months
Lumbar Spine L2-L4 Bone Mineral Density
baseline, 12 months
Geriatric Depression Scale
baseline, 3 months, 6 months, 9 months, 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTALtestosterone enanthate
Arm 2EXPERIMENTALfinasteride
Arm 3EXPERIMENTALtestosterone enanthate + finasteride
Arm 4PLACEBO_COMPARATORplacebo

Interventions

NameTypeDescription
Testosterone EnanthateDRUG125 mg, i.m. injection, once/week, for 52 weeks
FinasterideDRUG5 mg, oral, once/day, for 52 weeks
PlaceboOTHERPlacebo
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Eligibility Criteria

Age Range60 Years to N/A
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age \> 60 years males * Primary care at the Malcolm Randall VA Medical Center in Gainesville, Florida. * Consenting subjects who have a morning (between 6:00 AM and 10:00 AM) serum total testosterone 300 ng/dL or bioavailable testosterone concentration 70 ng/dL and no exclusio...

Countries:United States
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Frequently asked questions about Testosterone Enanthate

What is Testosterone Enanthate used for?

Testosterone Enanthate is used for male hypogonadism, a condition where the body does not produce enough testosterone. It is being investigated for its effects on muscle atrophy, sarcopenia, and benign prostate hypertrophy in men aged 60 years and older. The drug is currently in Phase 2 clinical development.

Who makes Testosterone Enanthate?

Testosterone Enanthate is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating male hypogonadism and related conditions.

What phase is Testosterone Enanthate in?

Testosterone Enanthate is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for its effects on male hypogonadism and associated conditions such as muscle atrophy and sarcopenia.

What clinical trials is Testosterone Enanthate in?

Testosterone Enanthate has one completed Phase 2 clinical trial registered under NCT00475501, titled '5-Alpha Reductase and Anabolic Effects of Testosterone.' The randomized, double-blind, placebo-controlled study enrolled 60 participants in the United States and investigated the drug's effects on male hypogonadism, muscle atrophy, sarcopenia, and benign prostate hypertrophy.

How does Testosterone Enanthate work?

Testosterone Enanthate is a small molecule that works by supplementing testosterone levels in the body. It is designed to address testosterone deficiency in men with hypogonadism, potentially improving muscle mass and function. The drug's mechanism involves replacing or augmenting the body's natural testosterone to restore normal physiological levels.

Is Testosterone Enanthate the same as testosterone?

Testosterone Enanthate is a form of testosterone, specifically an esterified version that allows for sustained release in the body. It is used to treat conditions related to low testosterone, such as male hypogonadism. The drug is being developed by Merck & Company, Inc. and is currently in Phase 2 clinical trials.