premenstrual syndrome premenstrual syndrome, esaxerenone
Conditions
Interventions
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.
Sponsors
Iwase Akira
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of adverse events causally related to esaxelenone administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Degree of improvement of each symptom associated with premenstrual syndrome. | — |
Contacts
Public ContactKohshiro Nakao
Gunma University Hospital
Outcome results
None listed