Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Testosterone

    Drug

    10,30,50 and 70 mg doses of micronized Testosterone delivered by means of a new liquid transdermal delivery solution, HypoSpray(R)once daily for 7 days or until halted due to systemic or dermal reactions.

  • Pump Sprayer

    Device

    A dose of product solution is delivered by means of a metered pump spray.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Forearm doseActive comparator 2 interventions
Group B: Chest DoseActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Dose Range Measure of serum levels of testosterone in response to varying doses

A pharmacokinetic measure of serum levels of testosterone in response to varying doses of from 10 to 70 mgs of Testosterone.

Time frame
1 week

Secondary outcomes

1

Dermal Safety as measured by

Incidence of treatment-emergent side effects.

Time frame
1 Week

Other outcomes

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: