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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT05607602
Eligibility Criteria:
Inclusion Criteria:
Group 1: 35 patients with ultrasound confirmed uterine fibroids. Group 1a: 35 patients with ultrasound confirmed uterine fibroids requiring myomectomy or hysterectomy.
Group 2: 35 control patients with a normal pelvis on ultrasound Able to provide informed consent
Exclusion Criteria:• Personal history of thrombosis
* Pregnant
* Post- partum (within 6 weeks)
* Surgery within 90 days
* Family history of thrombosis (first degree relative)
* Co-morbidities: cancer, liver impairment, renal impairment, uncontrolled hypertension
* Medication: Oral contraception containing oestrogen, hormone replacement therapy with oral oestrogen, antiplatelet therapy, anticoagulation
* Tranexamic Acid within last 48hrs, Zoladex within the last 33 days
* Smoker
* If anaemia (Hb \<110 g/L) is demonstrated on the study sample taken
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05607602
Study Brief:
Protocol Section:
NCT05607602