Product Transference Study of Testagen™ TDS®-Testosterone
ConditionHypogonadotropism
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTransdermal Delivery Solutions Corp
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Testagen® TDS Testosterone 5% HypoSpray®
DrugTopically applied Testosterone Hormone Replacement Lotion
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: UncoveredExperimental treatment 1 intervention
Group B: CoveredExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
30 minutes to 24 hours post doseSecondary 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.
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 doseOther outcomes
1
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.
Time frame
30 minutes to 24 hours post dose2
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.
Time frame
30 minutes to 24 hours post doseLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Transdermal Delivery Solutions Corp
Lead sponsor
Advanced Therapies Centre, The London Clinic
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: