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 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
NCT ID:
NCT06364592
Eligibility Criteria:
Inclusion Criteria:
* Meeting the diagnosis criteria of dysmenorrhea secondary to adenomyosis.
* Female patients aged between 18 and 50.
* Dysmenorrhea lasting for 3 consecutive menstrual cycles or more.
* At least three consecutive menstrual cycles with an interval of 24 to 38 days, differing by less than 7 days, and menstrual periods lasting 2 to 8 days before screening.
* At least 2 days of worst pain score ≥4 on Numerical Rating Scale during the screening period.
* Having not used medications, other than rescue medicine, or therapies for dysmenorrhea secondary to adenomyosis for at least 1 month before randomization, and consenting not to use throughout the process of the research.
* Volunteering to participate the trial and signing written informed consent.
Exclusion Criteria:
* Diagnosed with Endometriosis or having a history of endometriosis-related surgery
* Currently taking hormonal medications, including: a.use of GnRH agonists within 6 months before the screening period; b. use of progestins or danazol and other long-acting hormones within 3 months before the screening period; c. use of oral contraceptive-like short-acting hormones within one month before the screening period;
* Having clinically significant gynecologic condition such as clinically significant endometrial pathology, persistent complex ovarian cyst larger than 3 cm or simple ovarian cyst larger than 5 cm, or single fibroid 4 cm or larger or more than 4 fibroids measuring at least 2 cm or symptomatic submucosal fibroid of any size.
* having an IUD.
* HB \< 90G/L.
* Having any other chronic pain syndrome that required chronic analgesic or other chronic therapy.
* Having a current history of undiagnosed abnormal genital bleeding.
* Malignant tumors (including the reproductive system and other systems).
* Combined with severe diseases in the cardiac, respiratory, renal, liver, and hematopoietic systems, psychiatric disorder and/or cognitive disorders.
* Pregnant, breast feeding, planning a pregnancy within the next 7 months.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06364592
Study Brief:
Protocol Section:
NCT06364592