Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT02733133
Eligibility Criteria:
Inclusion Criteria:
1. Healthy Volunteers
2. Subject Couples, between 18 and 80 years of age, inclusive.
3. The subject couple is willing and able to read, understand the Subject Information Sheets 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 catheter on two separate occasions and the drawing of blood samples for the pharmacokinetic assessments.
9. The subject couple is willing and able to comply with all testing and requirements defined in the protocol.
10. The subject couple 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 or positive pregnancy test.
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 history of substance abuse or a current positive urine drug screen.
8. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males, and 14 for females).
9. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.
10. Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02733133
Study Brief:
Protocol Section:
NCT02733133