A Dose Ranging Study to Examine TDS-Testosterone 5%

NCT01894308 | Not Yet Recruiting Phase 2 DMC FDA Drug FDA Device

• 3 other identifiers: PARC-Testosterone-D1/09/132013-001766-42IRAS project ID: 146877
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypogonadotropism

Keywords

Male Hormone Replacement; Multiple Dose; Single Period; Phase II; Dose Ranging; Adult Male Subjects; Testosterone Replacement

Outcome Measures

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.

  1 week

Secondary Outcomes (1)

• Dermal Safety as measured by

  1 Week

Study Arms (2)

Forearm dose

ACTIVE COMPARATOR

Half of Ss will receive their dose of Testosterone on the inner aspects of their forearms.

Drug: Testosterone; Device: Pump Sprayer

Chest Dose

ACTIVE COMPARATOR

Half of Ss will receive their dose of Testosterone on the chest.

Drug: Testosterone; Device: Pump Sprayer

Interventions

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.

Chest Dose; Forearm dose

Pump Sprayer DEVICE

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

Chest Dose; Forearm dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypogonadal Male subjects - morning testosterone level ≤300 ng/dL (10.4 ng/L).
• 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.
• The subject is in otherwise good health as determined by medical history and physical examination.
• The subject is a non-smoker.
• 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.
• The subject is willing and able to comply with all testing and requirements defined in the protocol.
• The subject is willing and able to return to the study site for all visits.

You may not qualify if:

• 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.
• 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.
• 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.
• The subject has a Hematocrit level \> 51%
• The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.
• Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).
• Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.
• Subjects with an American Urological Association System Index for Prostatism score greater than 7
• Subjects with a history of prostate or breast carcinoma.
• Subjects with prostatic mass on screening physical examination.
• Subjects with a history of significant skin disease.
• Subjects with a history of sleep apnea.

Sponsors & Collaborators

• Transdermal Delivery Solutions Corp: lead
• Advanced Therapies Centre, The London Clinic: collaborator

Study Sites (1)

Advanced Therapies Centre, The London Clinic

London, NW1 4LJ, United Kingdom

Location

Related Publications (1)

• Chik Z, Johnston A, Tucker AT, Chew SL, Michaels L, Alam CA. Pharmacokinetics of a new testosterone transdermal delivery system, TDS-testosterone in healthy males. Br J Clin Pharmacol. 2006 Mar;61(3):275-9. doi: 10.1111/j.1365-2125.2005.02542.x.

  PMID: 16487220 BACKGROUND

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Shern L. Chew, M.D., Ph.D.

  Consultant Physician and Professor of Endocrine Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shern L. Chew, M.D., Ph.D.

CONTACT

011-44-20 034 6227; sl.chew@thelondonclinic.co.uk

Chandan AS Alam, MD

CONTACT

011-44-7785-717596; calam@tdsc.us

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 10, 2013
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)