Product Transference Study of Testagen™ TDS®-Testosterone

NCT02733133 | Unknown Phase 2 DMC

• 3 other identifiers: PARC-Testosterone-T1/09/132013-001767-23IRAS project ID: 146877
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypogonadotropism

Keywords

Testosterone; AndroGel; Transference; Women; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  30 minutes to 24 hours post dose

Other Outcomes (2)

• 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

  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

  30 minutes to 24 hours post dose

Study Arms (2)

Uncovered

EXPERIMENTAL

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®

Covered

EXPERIMENTAL

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®

Interventions

Testagen® TDS Testosterone 5% HypoSpray® DRUG

Topically applied Testosterone Hormone Replacement Lotion

Covered; Uncovered

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Volunteers
• Subject Couples, between 18 and 80 years of age, inclusive.
• The subject couple is willing and able to read, understand the Subject Information Sheets and provide written informed consent.
• The subject has a body mass index (BMI) within 18-30 kg/m2.
• The subject is in otherwise good health as determined by medical history and physical examination.
• 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.
• The subject is a non-smoker.
• 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.
• The subject couple is willing and able to comply with all testing and requirements defined in the protocol.
• The subject couple is willing and able to return to the study site for all visits.

You may not qualify if:

• 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.
• The subject has had a clinically significant illness within 30 days preceding entry into this study.
• The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
• The subject has a known allergy or history of hypersensitivity to Testosterone or similar compounds.
• 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).
• 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.
• The subject has a history of substance abuse or a current positive urine drug screen.
• Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males, and 14 for females).
• Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.
• Pregnancy

Sponsors & Collaborators

• Transdermal Delivery Solutions Corp: lead
• Advanced Therapies Centre, The London Clinic: collaborator

Related 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.

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Shern L. Chew, M.D., Ph.D.

  Consultant Physician and Professor of Endocrine Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: April 11, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share