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 @ 5:12 AM
Ignite Modification Date:
2025-12-25 @ 5:12 AM
NCT ID:
NCT03553927
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) ≥ 30 kg/m\^2 \[Part: 1, 2\& 3\]
* Evidence of reduced reproductive capacity (e.g. reduced sperm concentration \[applicable for study B\]
Exclusion Criteria:
* History of undescended testes, testicular surgery or mumps infection
* Hormonal therapy such as testosterone or selective oestrogen receptor modulators
* History of systemic cytotoxic therapy or pelvic radiotherapy
* Chronic systemic disease, such as cardiac, renal or liver failure
* At least one of the following:
Alcohol intake \>30 units per week Smoking daily Recreational drug use at a frequency not less than weekly
* Acute illness likely to affect the result of study
* Impaired ability to provide full consent to take part in the study
* An occupation requiring strenuous physical exercise that may require a high energy diet
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03553927
Study Brief:
Protocol Section:
NCT03553927