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A Dose Ranging Study to Examine TDS-Testosterone 5%

NCT01894308 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-09-03

No results posted yet for this study

Summary

This study is a continuation of previous studies done in healthy volunteers to prove the efficacy of delivering Testosterone, the male hormone, rapidly across intact skin in s series of doses from low to high in men with low-to-no natural testosterone production to measure their response to the varying doses. The results of this study will inform further studies which will be longer in length, as to the starting doses. The study will be conducted in London, U.K. at the Advanced Therapies Centre, The London Clinic.

Conditions

  • Hypogonadotropism

Interventions

DRUG

Testosterone

10,30,50 and 70 mg doses of micronized Testosterone delivered by means of a new liquid transdermal delivery solution, HypoSpray(R)once daily for 7 days or until halted due to systemic or dermal reactions.

DEVICE

Pump Sprayer

A dose of product solution is delivered by means of a metered pump spray.

Sponsors & Collaborators

  • Advanced Therapies Centre, The London Clinic

    collaborator OTHER

  • Transdermal Delivery Solutions Corp

    lead INDUSTRY

Principal Investigators

  • Shern L. Chew, M.D., Ph.D. · Consultant Physician and Professor of Endocrine Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-10-31
Completion
2027-02-28
FDA Drug
Yes
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01894308 on ClinicalTrials.gov