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Clinical Trials in the UK / NCT01894308
Starting soon Phase 2

A Dose Ranging Study to Examine TDS-Testosterone 5%

NCT01894308 · tracked via the Priya Life Science UK tracker
Sponsor
Transdermal Delivery Solutions Corp
Phase
Phase 2
Started
2026-06
Last updated
2025-09-03

Condition(s) studied

Hypogonadotropism

Investigational drug(s) / intervention(s)

TestosteronePump Sprayer

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

Study summary

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

Sex
MALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Hypogonadal Male subjects - morning testosterone level ≤300 ng/dL (10.4 ng/L). 2. 18 and 75 years of age, inclusive. 3. The subject is willing and able to read, understand the Subject Information Sheet and provide written informed consent. 4. The subject has a body mass index (BMI) within 18-30 kg/m2. 5. The subject is in otherwise good health as determined by medical history and physical examination. 6. The subject is a non-smoker. 7. The 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. 8. The subject is willing and able to comply with all testing and requirements defined in the protocol. 9. The subject is willing and able to return to the study site for all visits. Exclusion Criteria: 1. 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. 2. The subject has had a clinically significant illness within 30 days preceding entry into this study. 3. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease. 4. The subject has a known allergy or history of hypersensitivity to Testosterone or similar compounds. 5. 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. 6. The subject has donated or lost a significant volume of blood (\>450 mL) within four (4) weeks of the study, and their haemoglobin concentration and haematocrit have not returned to within 5% of normal. 7. The subject has a Hematocrit level \> 51% 8. The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test. 9. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males). 10. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry. 11. Subjects with an American Urological Association System Index for Prostatism score greater than 7 12. Subjects with a history of prostate or breast carcinoma. 13. Subjects with prostatic mass on screening physical examination. 14. Subjects with a history of significant skin disease. 15. Subjects with a history of sleep apnea. 16. Subject with a partner with a history of breast cancer. 17. Subject with a partner of child bearing potential who is not willing to use adequate contraception for the duration of the trial. 18. Subject whose partner is pregnant.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Advanced Therapies Centre, The London Clinic London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01894308 on ClinicalTrials.gov ↗ ← All trials in the UK