NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Uterine myoma
Date of first enrollment	25/11/2014
Target sample size	125
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : CDB-2914 INN of investigational material : ulipristal Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage and Administration for Investigational material : CDB-2914 will be orally administered once daily for 12 weeks. control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo will be orally administered once daily for 12 weeks. Generic name etc : Leuprorelin acetate INN of investigational material : leuprorelin Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage and Administration for Investigational material : Leuprorelin acetate will be subcutaneously injected once every 4 weeks.

Outcome(s)

Primary Outcome	Percentage of amenorrheic patients
Secondary Outcome	-Time to amenorrhea -Percent change in sum of volumes of 3 largest uterine myomas -Percent change in pain -QOL MRI,VAS,SF-36

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 50age old
Gender	Female
Include 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
Exclude 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