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Nanomilled testosterone

Phase 2

Hypogonadism | Small molecule | Endocrine |GSK plc|Last Updated: May 30, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

Nanomilled testosterone · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT0039858028-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal MenHypogonadism
COMPLETED43 Analytics
PHASE2COMPLETED
28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
HypogonadismUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine
days 1 and 28
lab tests for relative bioavailability of testosterone and dutasteride,
days 1, 2, 3, 19, 20, 21 & 26-31

Secondary Endpoints

Testosterone concentration .
on days 1 and 28
Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride
days 1 and 28.
Anabolic & androgenic Pharmacodynamic biomarkers
pre- and post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Nanomilled testosteroneDRUG -
Nanomilled dutasterideDRUG -
commercially available dutasterideDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexMALE
Healthy VolunteersNo
Study Sites7

Inclusion criteria: * Have a diagnosis of primary or secondary hypogonadism. * Have very low testosterone levels on 2 separate days. * Have a BMI within range of 18.5-35kg/m2. * Have not taken dutasteride for one year, or finasteride for the past 3 months. Exclusion criteria: * Have had or have b...

Countries:United States
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Frequently asked questions about Nanomilled testosterone

What is Nanomilled testosterone used for?

Nanomilled testosterone is an investigational small molecule being developed for hypogonadism, a condition in which the body does not produce enough testosterone. It is in Phase 2 clinical development and is not yet approved by the FDA.

Who makes Nanomilled testosterone?

Nanomilled testosterone is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 2 clinical trials for hypogonadism.

What phase is Nanomilled testosterone in?

Nanomilled testosterone is in Phase 2 clinical development for hypogonadism. It is an investigational drug and has not been approved by regulatory authorities. Two clinical trials have been completed, including one Phase 2 study.

What clinical trials is Nanomilled testosterone in?

Nanomilled testosterone has been studied in two completed clinical trials. NCT00398580 was a 28-day Phase 2 study in hypogonadal men, and NCT00400335 was a Phase 1 study on bioavailability and pharmacokinetics. Both trials were conducted in the United States.

Is Nanomilled testosterone the same as testosterone?

Nanomilled testosterone is a form of testosterone that has been nanomilled, a process that reduces particle size to improve absorption. It is being studied for hypogonadism, and in clinical trials it has been administered with and without dutasteride.