Study on the efficacy and safety of AT-04 for endometriosis

JRCT ID: jRCTs032230278

Registered date:04/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: endometriosis
• Date of first enrollment: 04/08/2023
• Target sample size: 50
• Study type: Interventional

Intervention(s)

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 1:1 basis.
The actual treatment group will receive AT-04 for 16 weeks. The control group will also be treated with S-02, a sham machine, for 16 weeks.
At the 16-week visit, subjects will be asked to bring their equipment and replace it with new equipment (all actual equipment). After the 16-week period, to ensure blinding after the replacement of the actual device, we will explain at the time of obtaining consent to participate in this study that the feeling of use may vary depending on the device under study.
The pads will be applied to at least two sites on the lower abdomen, including the uterine and ovarian areas, and if there are other painful areas, two additional sites (maximum 4 sites) will be applied to those areas.

Outcome(s)

• Primary Outcome: 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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Koga Kaori
• Source(s) of Monetary Support: Ministry of Economy, Trade and Industry