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A phase 3, multicenter, open-label, uncontrolled, long-term treatment study to evaluate the safety and efficacy of AKP-022 administered for 52 weeks in patients with uterine fibroids (LUNA2)

A phase 3 long-term treatment study to evaluate the safety and efficacy of AKP-022 in patients with uterine fibroids (LUNA2)

Hozumi Hiroyasu

ASKA Pharmaceutical Co., Ltd.

2-5-1, Shibaura, Minato-ku, Tokyo, Japan

aska-clinical@aska-pharma.co.jp

Hozumi Hiroyasu

ASKA Pharmaceutical Co., Ltd.

2-5-1, Shibaura, Minato-ku, Tokyo, Japan

+81-90-9275-1614

aska-clinical@aska-pharma.co.jp

Not Recruiting

Jan. 21, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

- 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

Female

Heavy menstrual bleeding associated with uterine fibroid

Oral administration of AKP-022

- Percent change in BMD from baseline at Week 52 of study treatment
- Incidence rate of endometrial hyperplasia up to Week 52 of study treatment

+81-3-3881-6116

Nov. 28, 2024

No

none