A phase 3 clinical study to compare the efficacy and safety of AKP-022 with placebo in patients with uterine fibroids

JRCT ID: jRCT2071240087

Registered date:19/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Heavy menstrual bleeding associated with uterine fibroid
• Date of first enrollment: 21/01/2025
• Target sample size: 75
• Study type: Interventional
• Intervention(s): Oral administration of AKP-022, placebo or relugolix

Outcome(s)

• Primary Outcome: Proportion of participants with a total PBAC score of < 10 from Week 18 to Week 24 of study treatment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

- Japanese premenopausal female patients who are aged 18 years or older
- Patients who had consecutive days of menstrual bleeding
- 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

Exclude 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

Related Information

• Primary Sponsor: Hozumi Hiroyasu