Male Hypogondism MedDRA version: 18.1 Level: LLT Classification code 10055043 Term: Blood dihydrotestosterone decreased System Organ Class: 10022891 - Investigations MedDRA version: 18.1 Level: PT Classification code 10005812 Term: Blood testosterone abnormal System Organ Class: 10022891 - Investigations MedDRA version: 18.1 Level: PT Classification code 10005811 Term: Blood testosterone System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: Testagen™ TDS®-Testosterone 5%
Pharmaceutical Form: Concentrate for cutaneous spray, emulsion
INN or Proposed INN: Testosterone
CAS Number: 65-06-5
Current Sponsor code: G03BA03
Other de
Sponsors
Seahorse Scientific Services Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be eligible from entry into the study: 1. Healthy Volunteers 2. Subject Couples, between 18 and 40 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. Female subjects must be practicing an acceptable method of birth control. Acceptable methods of birth control include hormonal contraceptives. If practicing an acceptable method of birth control, a negative urine pregnancy test result has been obtained on each Treatment Day. 7. The subject is a non-smoker. 8. The female subject must agree to comply with the placement of an indwelling intravenous cannula on two separate occasions and the drawing of blood samples for the pharmacokinetic assessments. 9. The subject is willing and able to comply with all testing and requirements defined in the protocol. 10. The subject is willing and able to return to the study site for all visits. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from entry into the study: 1. The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests (ALT or AST greater than 2 times the upper limit of normal, or renal dysfunction (creatinine >2mg/dL), 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 (excluding oral contraceptives). 6. The subject has donated or lost a significant volume of blood (>450mL) 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 Haematocrit level >51% or significant anaemia Haematocrit 4.0 ng/ml. 12. Subjects with a history of prostate cancer. 13. Subject with a history of breast cancer. 14. Active deep vein thrombosis, thromboembolic disorders or history of these conditions 15. Subjects with a history of significant skin disease. 16. Subjects with a history of sleep apnoea. 17. Subject of child bearing potential who is not willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of the trial. NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. 18. Subject who is pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine whether a topically applied formulation of Testosterone (Testagen™ TDS®-Testosterone) administered by pump dispenser spray to adult male subjects can be transferred by skin-to-skin contact to female companions during vigorous skin to skin contact and thereby theoretically but temporarily raising serum androgen levels in those women.;Secondary Objective: The secondary objective is to evaluate the tolerability and local and systemic effects of Testagen™ TDS®-Testosterone.;Primary end point(s): The primary objective is to determine whether a topically applied formulation of Testosterone (Testagen™ TDS®-Testosterone) administered by pump dispenser spray to adult male subjects can be transferred by skin-to-skin contact to female companions during vigorous skin to skin contact and thereby theoretically but temporarily raising serum androgen levels in those women.;Timepoint(s) of evaluation of this end point: Pharmacokinetic parameters will be summarised by number of observations (N), mean, standard deviation (SD), coefficient of variance (CV), median, maximum and minimum values. In addition, geometric means (GM) and geometric CVs will be calculated for AUC0-24 and Cmax. Summary statistics for Tmax, Lambda_Z and T½ will include N, mean, SD, median, minimum and maximum values. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The aim of testosterone replacement therapy is to produce serum levels that mimic the normal testosterone production and metabolism. The primary therapeutic purpose of Testagen™ TDS®-Testosterone is the restoration of serum testosterone levels to within the age-adjusted normal range for the Subject utilizing a safe transdermal delivery vehicle.;Timepoint(s) of evaluation of this end point: Full study duration. | — |
Countries
United Kingdom
Contacts
Public ContactProf Art Tucker
Seahorse Scientific Services Ltd.
Outcome results
None listed