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

A phase 3, randomized, multicenter, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of AKP-022 administered for 24 weeks in patients with endometriosis - LENA

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031250206
Enrollment
75
Registered
2025-07-02
Start date
2025-08-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Interventions

Sponsors

Kikuyama Ryoko
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: - Japanese premenopausal female patients who are aged 18 years or older - Patients who have been diagnosed with endometriosis - Patients who had consecutive days of bleeding - Patients who, along with their partners, 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 ovarian chocolate cysts measuring >= 10 cm and are aged 40 years or older at the time of examination - 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 genital bleeding - Patients with marked metrorrhagia or anovulatory bleeding - Patients with uterine fibroids requiring treatment - 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

MeasureTime frame
Change from Baseline in maximum VAS score for endometriotic pelvic pain from 20 to 24 weeks after administration of study drug

Contacts

Public ContactRyoko Kikuyama

ASKA Pharmaceutical Co., Ltd.

aska-clinical@aska-pharma.co.jp+81-70-4506-8508

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026