endometriosis dysmenorrhea heavy menstrual bleeding
Conditions
Interventions
After obtaining consent, eligibility for this study will be confirmed by screening tests, and central enrollment and randomized assignment to minimize bias will be conducted at the data center on a 1:
Sponsors
Koga Kaori
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Patients 18 years of age or older at the time consent is obtained (2) Premenopausal female patients (3) Patients with endometriosis (patients must meet one of the following conditions. In addition, if the disease recurs after surgery, the patient must be diagnosed again with one of the following) (1) Patients diagnosed with endometriosis by laparotomy or laparoscopy performed within 5 years prior to the start of treatment. (2) Patients with endometriosis detected by MRI or ultrasonography (transvaginal, transabdominal, or transrectal) performed within 1 year prior to the start of treatment, including ovarian chocolate cysts. (3) Patients with a diagnosis of clinical endometriosis based on either Douglas fossa induration, limited uterine mobility, or pelvic tenderness by internal or rectal examination performed prior to the start of treatment. (4) Patients with dysmenorrhea or pelvic pain that is thought to be derived from endometriosis, at least one of which is judged by the principal investigator to be moderate or higher on the B&B rating scale prior to the start of treatment (5) Patients with an average NRS (Numeric Rating Scale) score of 4 or higher for pain due to endometriosis during the 28 days prior to obtaining consent (6) Patients who have not started any new treatment for endometriosis or changed the treatment (including prescription details, dosage and administration) during the 28 days prior to obtaining consent. (7) Patients who, in the judgment of the Principal Investigator(s), have no evidence of acute deterioration of endometriosis during the 28 days prior to obtaining consent. (8) Patients who have given written consent to participate in the research of their own free will.
Exclusion criteria
Exclusion criteria: (1) Patients who used the following drugs within 8 weeks prior to obtaining consent Clinical trial drugs or investigational drugs GnRH analogs, danazol and aromatase inhibitors, selective estrogen receptor modulators (2) Patients who have previously used alternating magnetic field therapy devices, including study devices (3) Patients taking NSAIDs on a regular basis (4) Patients with ovarian chocolate cysts greater than 10 cm and age greater than 40 years (5) Patients with a history of bilateral oophorectomy (6) Patients with significant irregular uterine bleeding or unexplained irregular uterine bleeding as determined by the principal investigator. (7) Patients with uterine fibroids that, in the opinion of the Principal Investigator, require new treatment during the study period (8) Patients with irritable bowel syndrome and/or lower abdominal pain due to severe interstitial cystitis (9) Patients with a history or complications of severe hepatic disorder, jaundice, renal disorder, cardiovascular disease, endocrine system disease, metabolic disease, pulmonary disease, gastrointestinal disease, neurological disease, urological disease, immune disorder, psychiatric disease (especially depression-like symptoms), and suicide attempts due to such disorders (10) Patients using life-supporting medical electrical equipment such as artificial heart lungs and pacemakers. (11) Patients using medical electrical equipment such as electrocardiographs (12) Patients participating in clinical trials or clinical studies of other drugs or medical devices (13) Patients who need to be hospitalized for treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Numeric Rating Scale (NRS) score from collected at each visit for endometriosis-related pain at the end of the double-blind period (after 16 weeks) compared to baseline before the start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints 1Change in NRS score for endometriotic pelvic pain interviewed at the visit (4,8,12, and 20 weeks) compared to baseline before treatment initiation during the treatment period 2Change in NRS score for menstrual pain and endometriotic pelvic pain during the menstrual period compared to baseline before treatment initiation during the treatment period by eRPO (Electronic Patient-Reported Outcomes). 3 Change in NRS score for endometriosis pelvic pain other than menstrual periods during the treatment period compared to baseline before treatment initiation by ePRO. 4 Biberoglu & Behrman (B&B) score at the visit (4,8,12,16 and 20 weeks) compared to before treatment initiation 5 Endometriosis Health Profile-30 (EHP-30) score at the visit (4,8,12,16 and20 weeks) compared to before treatment initiation 6 Health-related quality of life (EQ-5D) at the visit (4,8,12,16 and 20 weeks) compared to before treatment initiation 7 Change in ovarian chocolate cyst size at the end of the treatment period (16 weeks) compared to baseline before treatment initiation Secondary safety endpoints Frequency and rate of occurrence of investigational device failure and adverse events | — |
Contacts
Public ContactHiroshi Ishikawa
Chiba University Hospital
Outcome results
None listed