NCT02733133

Product Transference Study of Testagen™ TDS®-Testosterone

A Single-Dose, Single Period, Phase II Pharmacokinetic Study To Examine Testagen™ TDS®-Testosterone For Its Potential To Be Inadvertently Transferred By Skin Contact After Dosing In Healthy Adult Subjects

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Transdermal Delivery Solutions Corp · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study will assess the potential of Testagen® TDS-Testosterone to enable transfer of Testosterone to females coming in contact with skin to which Testagen® TDS-Testosterone has been applied and the potential of product to raise serum androgen levels in those women.

Detailed description

48 Couples will be added to the protocol and a single dose applied by the male member of the couple. The female member of the couple will have undergone a baseline pharmacokinetic monitoring of her endogenous levels of Testosterone. At precise intervals by cohort on the day of the trial, the male will expose the skin onto which the trial materials were applied to the skin of his partner and she will then undergo another 24-hour multiple sample monitoring of her levels of testosterone.

Conditions

• Hypogonadotropism

Interventions

Type	Name	Description
DRUG	Testagen® TDS Testosterone 5% HypoSpray®	Topically applied Testosterone Hormone Replacement Lotion

Timeline

• Start date: 2016-11-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2016-04-11
• Last updated: 2024-11-20