Phase II Dose-Finding Study to Evaluate Efficacy and Safety of CDB-2914 in Patients with Uterine Myoma
- Conditions
- terine myoma
- Registration Number
- JPRN-jRCT2080222667
- Lead Sponsor
- ASKA Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 125
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of amenorrheic patients
- Secondary Outcome Measures
Name Time Method -Time to amenorrhea<br>-Percent change in sum of volumes of 3 largest uterine myomas<br>-Percent change in pain<br>-QOL<br>MRI,VAS,SF-36