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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT02994602
Eligibility Criteria:
Inclusion Male participant - Inclusion Criteria
Men who meet all the following criteria will be eligible for enrollment in the trial:
1. Good health as confirmed by medical history, physical examination, and clinical laboratory tests of blood and urine at the time of screening;
2. 18 to 50 years of age;
3. BMI ≥ 18 and \< 35 kg/m2;
4. No history of androgen use prior to the first screening visit as follows:
1. 1 month prior for oral or transdermal androgen,
2. 3 months prior for Testosterone cypionate or enanthate injection,
3. 6 months prior for Testosterone undecanoate injection;
5. Agreement to use a recognized effective method of short acting contraception with his partner (i.e. at a minimum use double-barrier method such as a condom with spermicide) during the entire study;
6. In the opinion of the investigator, male subject is willing and able to comply with the protocol;
7. Provision of valid, written and informed consent.
Female participant - Inclusion Criteria
Women who meet all the following criteria will be eligible for enrollment in the trial:
1. Good general health (BMI ≥18 and \<30 kg/m2)with no chronic medical conditions that result in periodic exacerbations which require significant medical care;
2. Aged between 18 and 40 years, at the enrollment visit;
3. Not pregnant and not breastfeeding.
4. Agreement to use a recognized effective method of contraception throughout the study
5. Willingness and ability to provide valid, written and informed consent and to comply with the protocol;
6. No desire for pregnancy within the next 6 months.
Exclusion Male participant - Exclusion Criteria
Men who meet any of the following criteria are not eligible for enrollment in the trial:
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 area of the study site or within a reasonable travel time from the site.
3. Any clinically significant abnormal findings at screening per the Investigator's medical judgement.
4. Elevated PSA (e.g. levels ≥ 4 ng/mL), according to study site's local laboratory reference normal values for adult men.
5. Abnormal serum chemistry values that may indicate clinically significant liver or kidney dysfunction. Other abnormal laboratory values may also be exclusionary, if so considered by the investigator to be clinically significant.
6. Use of androgens or other anabolic steroids that may affect testosterone measurements
7. Diastolic blood pressure (DBP) ≥ 85 and Systolic blood pressure (SBP) ≥ 135 mm Hg; (BP will be taken three times at approximately 5 minute intervals and the mean of the 3 measurements will be considered).
8. History of hypertension (well-controlled treated hypertension (\< 135/85) is allowed).
9. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.
10. Known hypersensitivity to progestins or testosterone.
11. History of prostate or breast carcinoma
12. Significant lower urinary obstructive symptoms (IPSS \> 19).
13. Known history of significant cardiac, renal, hepatic or prostatic disease.
14. History of thromboembolic disease.
15. A serious systemic disease such as diabetes mellitus (including diabetes controlled with treatment), HIV, or morbid obesity.
16. Current active or ongoing Hepatitis infection
17. Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance.
18. Known active or chronic dermatitis or other severe skin disorder.
19. Desiring fertility within 6 months of study participation.
20. History of severe depression or other serious mental health disorder.
21. Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their sporting status.
Female participant - Exclusion Criteria
Women who meet any of the following criteria are not eligible for enrollment in the trial:
1. Desire to become pregnant during the study.
2. Breastfeeding
3. Known or suspected current alcoholism or drug abuse.
4. History of thrombosis
5. Serum testosterone outside normal reference ranges by local laboratory standards or evidence of hirsutism (modified Ferriman-Galwey score \> 8)
6. Participation in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
7. Current pregnancy.
8. Known hypersensitivity to progestins or testosterone.
9. Any clinically significant abnormal findings at screening per the Investigator's medical judgement.
10. Use of androgens or other anabolic steroids that may affect testosterone measurements.
11. Known active or chronic dermatitis or other severe skin disorder.
12. Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance.
13. Not living in the catchment area of the study site or within a reasonable travel time from the site.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02994602
Study Brief:
Protocol Section:
NCT02994602