An Exploratory Study of the Safety and Efficacy of Esaxelenone for Premenstrual Syndrome

JRCT ID: jRCTs031240463

Registered date:06/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: premenstrual syndrome
• Date of first enrollment: 06/11/2024
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Beginning on the 15th day after the onset of menstruation, Esaxelenone is administered in 1.25 mg or 2.5 mg once daily after breakfast for 14 days, according to the 3+3 design.

Outcome(s)

• Primary Outcome: Percentage of adverse events causally related to esaxelenone administration.
• Secondary Outcome: Degree of improvement of each symptom associated with premenstrual syndrome.

Key inclusion & exclusion criteria

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

Include criteria

1) Patients diagnosed with PMS according to the criteria of the American College of Obstetricians and Gynecologists.
2) Patients who provide written consent to participate in this study.
3) Premenopausal women who are at least 18 years of age as of the date consent is obtained.
4) Patients with a menstrual cycle of 28 +/- 3 days.
5) Patients who are able to cooperate with the use of condom contraception during the study period.

Exclude criteria

1) Patients with a history of treatment with oral contraceptives or sex hormones such as estrogen/progestin combination drugs within 4 weeks prior to enrollment.
2) Patients with a history of treatment with herbal medicines, antidepressants (tricyclics, tetracyclics, SSRIs, SNRIs), anxiolytics (benzodiazepines, serotonergic agents) or atypical antipsychotics (serotonin-dopamine blockers, multiple receptor antipsychotics, partial dopaminergic agents) within 2 weeks before registration.
3) Patients with a history of hypersensitivity to esaxelenone ingredients.
4) Patients with hyperkalemia or serum potassium levels greater than 5.0 mEq/L at the time of enrollment in this study.
5) Patients with severe renal dysfunction (eGFR < 30 mL/min/1.73 m2).
6) Patients receiving potassium retaining diuretics, aldosterone antagonists, or potassium preparations.
7) Patients with systolic blood pressure less than 100 mmHg or with symptoms of hypotension.
8) Patients who are otherwise judged by the physician to be ineligible for the study.

Related Information

• Primary Sponsor: Iwase Akira