Back to resultsProduct Transference Study of Testagen™ TDS®-Testosterone (TRANSFERENCE)
Primary Purpose
Hypogonadotropism
Status
Enrolling by invitation
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Testagen® TDS Testosterone 5% HypoSpray®
Sponsored by
About this trial
This is an interventional prevention trial for Hypogonadotropism focused on measuring Testosterone, AndroGel, Transference, Women, Children
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Uncovered
Covered
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02733133
First Posted
March 10, 2016
Last Updated
November 30, 2022
Sponsor
Transdermal Delivery Solutions Corp
Collaborators
Advanced Therapies Centre, The London Clinic
1. Study Identification
Unique Protocol Identification Number
NCT02733133
Brief Title
Product Transference Study of Testagen™ TDS®-Testosterone
Acronym
TRANSFERENCE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 2016 (undefined)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Transdermal Delivery Solutions Corp
Collaborators
Advanced Therapies Centre, The London Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadotropism
Keywords
Testosterone, AndroGel, Transference, Women, Children
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Uncovered
Arm Type
Experimental
Arm Description
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.
Arm Title
Covered
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Testagen® TDS Testosterone 5% HypoSpray®
Intervention Description
Topically applied Testosterone Hormone Replacement Lotion
Primary Outcome Measure Information:
Title
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.
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.
Time Frame
30 minutes to 24 hours post dose
Secondary Outcome Measure Information:
Title
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.
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 Area Under the Curve (AUC) for 24 hours post dose measured in ng/dL Testosterone as determined by ELISA method.
Time Frame
30 minutes to 24 hours post dose
Other Pre-specified Outcome Measures:
Title
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
Description
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.
Time Frame
30 minutes to 24 hours post dose
Title
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
Description
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.
Time Frame
30 minutes to 24 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shern L. Chew, M.D., Ph.D.
Organizational Affiliation
Consultant Physician and Professor of Endocrine Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/16487220?dopt=Abstract
Description
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.
Learn more about this trial
Product Transference Study of Testagen™ TDS®-Testosterone
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