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
Qualifiers
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
Treatments tested in this trial
- Testagen® TDS Testosterone 5% HypoSpray®
Treatment groups
96 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Transdermal Delivery Solutions Corp
Lead sponsor
Advanced Therapies Centre, The London Clinic
Collaborator
Source ClinicalTrials.gov