Uterine myoma
Conditions
Sponsors
ASKA Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - The patient is capable of understanding the requirements for this protocol and providing voluntary written informed consent for participation in this study. - Premenopausal Japanese woman between the ages of 20 and 50 years at the time consent is obtained. - The patient has experienced 2 or more regular menstrual cycles (22 to 35 days) immediately before informed consent and that should include menstrual bleeding of at least 3 consecutive days. - The patient was diagnosed with uterine myoma associated with menorrhagia and has a PBAC score > 100 within the first 8 days of menstruation during pre-treatment observation period. - The patient has 1 or more measurable myomas, with a longest diameter of at least 3 cm confirmed by transvaginal sonography during pre-treatment observation period. - The patient and her partner is capable of practicing appropriate birth control, except for oral contraceptives and IUD, during the study period.
Exclusion criteria
Exclusion criteria: - The patient has a surgical history (including uterine artery embolization) of uterine myomas for evaluation. - The patient has a malignant tumor or a history of a malignant tumor within the 5 years before the informed consent. - The patient has endometrial polyps greater than 2 cm. - The patient has ovarian cysts 4 cm or greater. - The patient has a current history of marked metrorrhagia. - The patient has hemoglobinopathy or severe abnormal coagulation. - The patient has alcohol or substance addiction. - The patient has current history of severe cardiovascular disease, gastrointestinal disease, pulmonary disease, urological disease, endocrine system disease, metabolic disorder, neural disease, mental disorder, or immune disease. - The patient is allergic to ingredients in the investigational product, SPRM, progestins, or GnRH derivatives (LH-RH derivatives). - The patient is pregnant or lactating. The patient has positive pregnancy test results during pre-treatment observation period or wants to become pregnant during the study period. - The patient has significant abnormal findings in endometrial biopsy conducted during pre-treatment observation period. - The patient has a positive cervical cytology result conducted within 1 year before informed consent or conducted during pre-treatment observation period. - The patient has hepatic function abnormal during pre-treatment observation period. - The patient has a treatment plan for menorrhagia during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Percentage of amenorrheic patients, Incidence of adverse drug reactions | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - Incidence of adverse events - Percent change in sum of volumes of 3 largest uterine myomas - Percent change in pain - Percent change in QOL | — |
Countries
Japan
Outcome results
None listed