Topical Testosterone Replacement in Patient Volunteers with low blood testosterone levels.

Phase 1

• Conditions: Male Hypogondism; MedDRA version: 18.1Level: LLTClassification code 10055043Term: Blood dihydrotestosterone decreasedSystem Organ Class: 10022891 - Investigations; MedDRA version: 18.1Level: PTClassification code 10005812Term: Blood testosterone abnormalSystem Organ Class: 10022891 - Investigations; MedDRA version: 18.1Level: PTClassification code 10005811Term: Blood testosteroneSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2013-001767-23-GB
• Lead Sponsor: Seahorse Scientific Services Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-04
• Last Update Posted: 30 May 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 64

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

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 <35%)
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, or more than 14 standard drinks per week for females).
10. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.
11. Male Subjects with an American Urological Association Symptom Index for Benign prostatic hyperplasia score greater than 7 and/or elevated PSA reading >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified