Fezolinetant Experience for the Treatment of Vasomotor Symptoms Associated with Menopause Among Women in a German Real-life Setting

Study identification

• EU PAS number:
  EUPAS1000000132
• Study ID:
  1000000132
• Official title and acronym:
  Fezolinetant Experience for the Treatment of Vasomotor Symptoms Associated with Menopause Among Women in a German Real-life Setting
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This study is for women in Germany who are going through menopause. ; They have symptoms including hot flashes and night sweats (also called vasomotor symptoms). Their doctor has decided to give them fezolinetant tablets to help treat these symptoms. ; Fezolinetant tablets do not contain hormones. Fezolinetant tablets have been approved in some countries to treat hot flashes and night sweats.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Astellas Pharma Europe Ltd.

Study timelines

Date when funding contract was signed

Actual:22/07/2024

Study start date

Actual:18/06/2024

Data analysis start date

Planned:08/04/2026

Date of final study report

Planned:15/01/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Europe Ltd.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

2693-MA-3549