A Dose Ranging Study to Examine TDS-Testosterone 5% (PARC-T-D)
Primary Purpose
Hypogonadotropism
Status
Not yet recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Testosterone
Pump Sprayer
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadotropism focused on measuring Male Hormone Replacement, Multiple Dose, Single Period, Phase II, Dose Ranging, Adult Male Subjects, Testosterone Replacement
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- Subject with a partner with a history of breast cancer.
- Subject with a partner of child bearing potential who is not willing to use adequate contraception for the duration of the trial.
- Subject whose partner is pregnant.
Sites / Locations
- Advanced Therapies Centre, The London Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Forearm dose
Chest Dose
Arm Description
Half of Ss will receive their dose of Testosterone on the inner aspects of their forearms.
Half of Ss will receive their dose of Testosterone on the chest.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Dermal Safety as measured by
Incidence of treatment-emergent side effects.
Full Information
NCT ID
NCT01894308
First Posted
July 3, 2013
Last Updated
August 30, 2023
Sponsor
Transdermal Delivery Solutions Corp
Collaborators
Advanced Therapies Centre, The London Clinic
1. Study Identification
Unique Protocol Identification Number
NCT01894308
Brief Title
A Dose Ranging Study to Examine TDS-Testosterone 5%
Acronym
PARC-T-D
Official Title
A Multiple-Dose, Single Period, Phase II Dose Ranging Study to Examine TDS-Testosterone 5% in Adult Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2024 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Transdermal Delivery Solutions Corp
Collaborators
Advanced Therapies Centre, The London Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
48 Patients will be enrolled following 2 independent verifying blood tests of their diagnosis of Hypogonadism. there will be 4 cohorts of 12 subjects, each receiving doses of the trail materials, titrated by means of number of sprays applied. Doses will range from 10 to 70 mgs Testosterone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadotropism
Keywords
Male Hormone Replacement, Multiple Dose, Single Period, Phase II, Dose Ranging, Adult Male Subjects, Testosterone Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Forearm dose
Arm Type
Active Comparator
Arm Description
Half of Ss will receive their dose of Testosterone on the inner aspects of their forearms.
Arm Title
Chest Dose
Arm Type
Active Comparator
Arm Description
Half of Ss will receive their dose of Testosterone on the chest.
Intervention Type
Drug
Intervention Name(s)
Testosterone
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Pump Sprayer
Intervention Description
A dose of product solution is delivered by means of a metered pump spray.
Primary Outcome Measure Information:
Title
Dose Range Measure of serum levels of testosterone in response to varying doses
Description
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 Outcome Measure Information:
Title
Dermal Safety as measured by
Description
Incidence of treatment-emergent side effects.
Time Frame
1 Week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
Subject with a partner with a history of breast cancer.
Subject with a partner of child bearing potential who is not willing to use adequate contraception for the duration of the trial.
Subject whose partner is pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shern L. Chew, M.D., Ph.D.
Phone
011-44-20 034 6227
Email
sl.chew@thelondonclinic.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Chandan AS Alam, MD
Phone
011-44-7785-717596
Email
calam@tdsc.us
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shern L. Chew, M.D., Ph.D.
Organizational Affiliation
Consultant Physician and Professor of Endocrine Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Therapies Centre, The London Clinic
City
London,
ZIP/Postal Code
NW1 4LJ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16487220
Citation
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.
Results Reference
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A Dose Ranging Study to Examine TDS-Testosterone 5%
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