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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT01124357
Eligibility Criteria:
Inclusion Criteria:
* Women with no desire to preserve their fertility who have heavy menstrual bleeding without organic pathology (DUB) of more than six months duration
* Premenopausal follicular follicle stimulating hormone (FSH) level of less than 40 IU/L.
* Associated functional disability (negative impact on life quality).
* Lack of response to medical treatment.
* Prepared to undergo surgical treatment without general anaesthesia
Exclusion Criteria:
* Women under 25 years
* Suspected genital tract infection
* Uterine pathology including endometrial pathology on endometrial biopsy (e.g. endometrial hyperplasia or carcinoma) and structural lesions (e.g. uterine malformations, adhesions, polyps, submucous fibroids or extracavity fibroids \> 3cm in diameter) as identified on pelvic ultrasound and/or outpatient hysteroscopy.
* Uterine cavity length \>11cm
* Adnexal pathology
* Previous open myomectomy or endometrial ablation / resection and classical caesarian section
* patients considered vulnerable (e.g. current mental illness, emotionally labile, learning difficulties, immaturity)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Study:
NCT01124357
Study Brief:
Protocol Section:
NCT01124357