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:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-24 @ 11:58 AM
NCT ID:
NCT02432261
Eligibility Criteria:
Inclusion Criteria:
1. Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening;
2. 18 to 50 years of age;
3. BMI \< 33 calculated as weight in Kg/(height in cm)2;
4. No history of hormonal therapy use in the last six months prior to the first screening visit;
5. Subject will agree to use a recognized effective method of contraception with his partner (i.e. at a minimum, condom for the male partner and an effective contraception for the female partner) during the course of the study treatment and recovery phase;
6. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form;
7. Does not meet any of the exclusion criteria.
8. Sperm concentration ≥ 15 million sperm per milliliter ejaculate.
Exclusion Criteria:
1. Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit;
2. Men not living in the catchment's area of the clinic or within a reasonable distance from the site;
3. Clinically significant abnormal physical findings at screening;
4. Elevated PSA (levels ≥ 4 ng/mL), according to local laboratory normal values;
5. Abnormal serum chemistry values, according to local laboratory normal values that indicate liver or kidney dysfunction or that may be considered clinically significant;
6. Use of androgens or body building substances within 6 months before first screening visit;
7. Diastolic blood pressure (DBP) \> 80 and/or Systolic (SBP) \> 130 mm Hg;
8. EKG abnormal and clinically significant and QTC level longer than 450msec;
9. History of hypertension, including hypertension controlled with treatment;
10. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis;
11. Known hypersensitivity to progestins or androgen;
12. Family or personal history of venous thromboembolism;
13. Benign or malignant liver tumors; active liver disease;
14. Known history of reproductive dysfunction including vasectomy or infertility;
15. Known history of cardiovascular, renal, hepatic or prostatic disease;
16. A serious systemic disease such as diabetes mellitus or morbid obesity (body weight greater than 120% of ideal body weight or BMI limitation as above);
17. Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones and study treatment compliance;
18. Known dermatitis or severe skin disorder;
19. Moderate or severe depression as determined by PHQ-9 score \>15;
20. Partner is known to be pregnant;
21. Known or suspected breast or prostate cancer;
22. Allergic to any ingredient in testosterone/nestorone gel, including alcohol;
23. Known history of untreated sleep apnea;
24. International Prostate Symptom Score (IPSS) greater than or equal to 15.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02432261
Study Brief:
Protocol Section:
NCT02432261