A Dose Ranging Study to Examine TDS-Testosterone 5%
ConditionHypogonadotropism
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-75
SponsorTransdermal Delivery Solutions Corp
About this trial
This study is a continuation of previous studies done in healthy volunteers to prove the efficacy of delivering Testosterone, the male hormone, rapidly across intact skin in s series of doses from low to high in men with low-to-no natural testosterone production to measure their response to the varying doses. The results of this study will inform further studies which will be longer in length, as to the starting doses. The study will be conducted in London, U.K. at the Advanced Therapies Centre, The London Clinic.
Eligibility criteria
Qualifiers
Hypogonadal Male subjects - morning testosterone level ≤300 ng/dL (10.4 ng/L).
18 and 75 years of age, inclusive.
The subject is willing and able to read, understand the Subject Information Sheet 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 >4.0 ng/ml or ALT and AST greater than 2 times the upper limit of normal, clinically significant anemia (hematocrit <35%) or renal dysfunction (creatinine >2mg/dL), active deep vein thrombosis, thromboembolic disorders or history of these conditions.
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
- Testosterone
- Pump Sprayer
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Transdermal Delivery Solutions Corp
Lead sponsor
Advanced Therapies Centre, The London Clinic
Collaborator
Source ClinicalTrials.gov