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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT04426760
Eligibility Criteria:
Inclusion Criteria:
* Age: 18 to 40 years
* Presence of leiomyoma(s)
* Regular menstrual cycle (28 +/- 7 days)
* Having had at least 2 normal menstrual cycles after ending the treatment if previously treated with GnRH analogue
* Signed informed consent
Exclusion Criteria:
* No treatment indication (no symptoms and/or no desire for fertility)
* Contraindication for surgery
* Known endometriosis
* Known PCOS
* Untreated hydrosalpinx
* Malignancy; gynaecological or other location
* Pre-malignant or malignant pap smear or endometrial biopsy
* Hormonal treatment including ulipristal acetat and levonorgestrel intrauterine device last three months before inclusion in the study
* Ongoing treatment with GnRH analogue
* Pregnancy last 3 months
* Ongoing lactation
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04426760
Study Brief:
Protocol Section:
NCT04426760