JPRN-jRCT2080223680CompletedPhase 3
Phase III Clinical Study to Evaluate Efficacy and Safety of CDB-2914 Compared with Leuprorelin Acetate in Patients with Uterine Myoma
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 192
Study Overview
Brief Summary
The percentage of amenorrheic subjects with symptomatic uterine fibroids, which was the primary endpoint, showed the noninferiority of CDB-2914 to leuprorelin, demonstrating the efficacy of CDB-2914. For safety, no adverse events characteristic of CDB-2914 were observed, and no particular safety issues were raised.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to <= 50age old (—)
- Sex
- Female
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
- •- 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 a previous or current history of osteoporosis, osteopenia, or other metabolic bone diseases.
- •- 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.
Investigators
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