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Testagen

KEDG, Testicular bioregulator peptide

Quick Stats
Studies 1
Trials 1
Enrolling By Invitation PHASE2 INTERVENTIONAL NCT02733133

Product Transference Study of Testagen™ TDS®-Testosterone

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

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

Primary Outcomes

Measure: Transference of Topical Testosterone from Dosed Males to Female Partners As Measured by net change from Baseline of Serum Testosterone in nG/dL expressed as Maximum Serum Concentration or Cmax.
TimeFrame: 30 minutes to 24 hours post dose
Description: Determination of whether testosterone from the Testagen® preparation is transferable from the skin of the patient to his partner and therefore detectable in the blood of female partner and if so, how much as measured by ELISA method as applied to blood samples and computed for Concentration Max (Cmax) for 24 hours post dose measured in ng/dL Testosterone as determined by ELISA method.

Trial Information

NCT ID

NCT02733133

Status

Enrolling By Invitation

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Transdermal Delivery Solutions Corp

Last Updated

December 15, 2025