Uterine myoma
Conditions
Sponsors
ASKA Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: -Patients providing written informed consent -Premenopausal Japanese women between the ages of 20 and 50 years at the time consent is obtained -Patients with a menstrual cycle of 22 to 35 days -Patients with heavy bleeding for at least one day within the first 8 days of menstruation at screening who are diagnosed with menorrhagia -Patients with hemoglobin level from 6.0 g/dL to less than 11.5 g/dL at screening -Patients with one or more uterine myomas at least 3 cm in diameter and no uterine myomas more than 12 cm in diameter on pelvic MRI at screening -Patients whose uterus is no larger than at Week 16 of pregnancy at screening -Patients planning to undergo surgery (such as hysterectomy and myomectomy) at or after the end of the study treatment period -Patients who are able to practice appropriate birth control, including their partners, except for oral contraceptives, during the study period
Exclusion criteria
Exclusion criteria: -Patients with a history of surgery potentially affecting uterine evaluation in the study, or patients with a history of endometrial curettage, embolization, or microwave endometrial ablation -Patients with prior, concurrent, or suspected cervical cancer, endometrial cancer, ovarian cancer, breast cancer, or endometrial hyperplasia -Patients with endometrial polyps greater than 2 cm -Patients with calcified myoma -Patients with one or more ovarian cysts 4 cm or greater -Patients with hemoglobinopathy or severe abnormal coagulation -Patients who are pregnant or lactating. Patients who have positive pregnancy test results at screening or who want to become pregnant during the study period -Patients with alcohol or substance addiction -Patients with allergies to investigational product ingredients, SPRMs, progestins, or GnRH derivatives -Patients with previous or concurrent osteoporosis -Patients with hepatic function abnormal at screening -Patients on SPRMs -Patients using IUDs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of amenorrheic patients | — |
Secondary
| Measure | Time frame |
|---|---|
| -Time to amenorrhea -Percent change in sum of volumes of 3 largest uterine myomas -Percent change in pain -QOL MRI,VAS,SF-36 | — |
Outcome results
None listed