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LUNA2: Long-term safety and efficacy of AKP-022 in uterine fibroids
jRCT2031240570Phase 3Active, not recruiting
- Sponsor
- ASKA Pharmaceutical Holdings Co., Ltd.
- Start
- Feb 2025
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 3, open-label, single-arm trial of relugolix + estradiol + norethindrone in Fibromyoma (LM) and hypermenorrhea, sponsored by ASKA Pharmaceutical Holdings Co., Ltd. Primary endpoints: Percent change in bone mineral density at Week 52 and Incidence of endometrial hyperplasia up to Week 52. Started Feb 2025; status: active, not recruiting.
02
Drugs
relugolix + estradiol + norethindrone
03
Conditions
Fibromyoma (LM)hypermenorrhea
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