Heavy menstrual bleeding associated with uterine fibroid
Conditions
Interventions
Oral administration of AKP-022
Sponsors
Hozumi Hiroyasu
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - Japanese premenopausal female patients who are aged 18 years or older - Patients with at least 1 measurable fibroid on transvaginal ultrasound, excluding calcified fibroids - Patients with a diagnosis of menorrhagia - Patients who are capable of using appropriate contraception during the study period
Exclusion criteria
Exclusion criteria: - Patients who have had a hysterectomy or bilateral oophorectomy - Patients with pathologic findings other than uterine fibroid that could either cause or contribute to menorrhagia, or any other clinically significant gynecologic disorder - Patients with a current history of thyroid dysfunction with irregular menstruation, or with a potential for irregular menstruation due to thyroid dysfunction - Patients with undiagnosed abnormal vaginal bleeding - Patients with marked metrorrhagia or anovulatory bleeding - Patients with current or previous blood disorders (e.g., thalassemia, sickle cell anemia, folic-acid deficiency, and coagulopathy), excluding iron-deficiency anemia or latent iron-deficiency anemia - Patients with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis - Patients with current or previous osteoporosis, osteopenia, or other metabolic bone diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Percent change in BMD from baseline at Week 52 of study treatment - Incidence rate of endometrial hyperplasia up to Week 52 of study treatment | — |
Contacts
Public ContactHiroyasu Hozumi
ASKA Pharmaceutical Co., Ltd.
Outcome results
None listed