Product Transference Study of Testagen™ TDS®-Testosterone (TRANSFERENCE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypogonadotropism
• Intervention / Treatment: Drug: Testagen® TDS Testosterone 5% HypoSpray®

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chandan A.S. Alam, M.D.; Phone Number: 02082456222; Email: Chandan1@aol.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy Volunteers
2. Subject Couples, between 18 and 80 years of age, inclusive.
3. The subject couple is willing and able to read, understand the Subject Information Sheets and provide written informed consent.
4. The subject has a body mass index (BMI) within 18-30 kg/m2.
5. The subject is in otherwise good health as determined by medical history and physical examination.
6. Female subjects must be practicing an acceptable method of birth control. Acceptable methods of birth control include hormonal contraceptives. If practicing an acceptable method of birth control, a negative urine pregnancy test result has been obtained on each Treatment Day.
7. The subject is a non-smoker.
8. The female subject must agree to comply with the placement of an indwelling catheter on two separate occasions and the drawing of blood samples for the pharmacokinetic assessments.
9. The subject couple is willing and able to comply with all testing and requirements defined in the protocol.
10. The subject couple is willing and able to return to the study site for all visits.

Exclusion Criteria:

1. The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator, particularly an elevated PSA reading or positive pregnancy test.
2. The subject has had a clinically significant illness within 30 days preceding entry into this study.
3. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
4. The subject has a known allergy or history of hypersensitivity to Testosterone or similar compounds.
5. The subject has used any prescription medication within 14 days or over-the-counter (OTC) medication or alcohol within 48 hours of dosing or intends to use any prescription or OTC medication during the study that may interfere with the evaluation of study medication (excluding oral contraceptives).
6. The subject has donated or lost a significant volume of blood (>450mL) within four (4) weeks of the study, and their haemoglobin concentration and haematocrit have not returned to within 5% of normal.
7. The subject has a history of substance abuse or a current positive urine drug screen.
8. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males, and 14 for females).
9. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.
10. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Uncovered; Half of the male partners in each cohort will apply the Testagen® TDS Testosterone 5% HypoSpray® and cover the area before engaging in contact with the female partner.	Drug: Testagen® TDS Testosterone 5% HypoSpray®; Topically applied Testosterone Hormone Replacement Lotion
Experimental: Covered; Half of the male partners in each cohort will apply the Testagen® TDS Testosterone 5% HypoSpray® and will not cover the area before engaging in contact with the female partner.	Drug: Testagen® TDS Testosterone 5% HypoSpray®; Topically applied Testosterone Hormone Replacement Lotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	30 minutes to 24 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Area Under Curve or AUC.	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 Area Under the Curve (AUC) for 24 hours post dose measured in ng/dL Testosterone as determined by ELISA method.	30 minutes to 24 hours post dose

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Transdermal Delivery Solutions Corp
• Collaborators: Advanced Therapies Centre, The London Clinic
• Investigators: Principal Investigator: Chandan A.S. Alam, M.D., Consultant Physician

Publications and helpful links

Helpful Links

• Chik Z, Johnston A, Tucker AT, Chew SL, Michaels L, Alam CA. Pharmacokinetics of a new testosterone transdermal delivery system, TDStestosterone in healthy males. Br J Clin Pharmacol. 2006 Mar;61(3):2759.

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2027
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (Estimated): April 11, 2016

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Women; Children; Testosterone; Transference; AndroGel
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: PARC-Testosterone-T1/09/13; IRAS project ID: 146877 (Other Identifier: London - West London & GTAC Research Ethics Committee); 2013-001767-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No