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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT02571205
Eligibility Criteria:
Inclusion Criteria:
* A molecular diagnosis of Duchenne Muscular Dystrophy.
* Males aged between 12 and 17 years of age at time of first dosing
* Prepubertal (Tanner stage 1, testicular volume \<4 mls, initial testosterone level of \<2.0 nmol/l)
* Subjects are receiving the standard of care for DMD as recommended by the NorthStar UK and TREAT-NMD guidelines
* Patients are capable of sitting upright in a wheelchair for at least an hour
* Patients have stable respiratory function. Artificial ventilation with either Bipap/continuous positive airways pressure (CPAP) or tracheostomy is not a contraindication to the study.
* Informed consent/assent signed by the patient (or parent/guardian if under 16 years of age)
Exclusion Criteria:
* Severe learning difficulties that would preclude them from cooperating with examination.
* Anticipated surgery during the study period.
* Symptomatic cardiac failure.
* Participants/families who may have emotional or psychological problems if recruited to a study
* Hypersensitivity to the active substance or to any of the excipients, including arachis oil or derivatives (including hypersensitivity and allergy to peanuts or soya.)
* Any contra-indication to receiving an intramuscular injection
* Any additional chronic disease that affects androgen production
* Anti-coagulant therapy
* If participation in the study is not recommended in the opinion of the investigators
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT02571205
Study Brief:
Protocol Section:
NCT02571205