NCT01894308

A Dose Ranging Study to Examine TDS-Testosterone 5%

A Multiple-Dose, Single Period, Phase II Dose Ranging Study to Examine TDS-Testosterone 5% in Adult Male Subjects

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Transdermal Delivery Solutions Corp · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

48 Patients will be enrolled following 2 independent verifying blood tests of their diagnosis of Hypogonadism. there will be 4 cohorts of 12 subjects, each receiving doses of the trail materials, titrated by means of number of sprays applied. Doses will range from 10 to 70 mgs Testosterone.

Conditions

• Hypogonadotropism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2026-10-01
• Completion: 2027-02-01
• First posted: 2013-07-10
• Last updated: 2025-09-03

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study