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 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT06478992
Eligibility Criteria:
Inclusion Criteria:
* Pain due to adenomyosis (lower abdominal pain and low back pain) visual analogue scale (VAS) ≥40mm or menstrual volume score (PBAC) ≥100;
* Adenomyosis was confirmed by ultrasound or magnetic resonance imaging (MRI);
* The uterine volume measured by transvaginal gynecological three-dimensional ultrasound was more than 150cm3 and less than 280cm3 (the volume was about 280cm3 at 10 weeks of pregnancy); ④ A strong desire to preserve the uterus; ⑤ No fertility requirements within nearly one year;
* Premenopausal women aged ≥18 years old; ⑦ Willing and able to abide by the study protocol, and have the ability to clearly judge the amount of menstruation and the degree of pain.
Exclusion Criteria:
* Presence of contraindications to Mirena (known or suspected pregnancy, current pelvic inflammatory disease or recurrent pelvic inflammatory disease, lower genital tract infection, postpartum endometritis, infectious abortion within the past 3 months, cervicitis, cervical dysplasia, uterine or cervical malignant lesions, progestin-dependent tumors, abnormal uterine bleeding of unknown cause, congenital or acquired uterine abnormalities, these include fibroids that deform the cervix, conditions that increase susceptibility to infections, acute liver diseases or tumours, allergy to active ingredients or excipient);
* Malignant tumors (including reproductive system and other systems);
* Acute stage of heart, liver and kidney failure or other patients who cannot tolerate operation;
* The history of Mirena displacement or expulsion;
* Ultrasound showed the presence of ovarian chocolate cyst; ⑥ The presence of deep endometrial nodules by gynecological examination;
* The presence of intramural or subserous myoma ≥3cm or any size of uterine submucosal myoma (type 0, 1, 2); ⑧ Patients who are unwilling to participate in the study or who were considered by the investigators to be unsuitable for the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06478992
Study Brief:
Protocol Section:
NCT06478992