Assessment of the effectiveness of additional Risk Minimisation Measures (aRMMs) among pharmacists for provision of Estradiol hemihydrate 10 micrograms vaginal tablets in a community pharmacy setting

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000274
• EU PAS number:
  EUPAS1000000274
• Study ID:
  1000000274
• Official title and acronym:
  Assessment of the effectiveness of additional Risk Minimisation Measures (aRMMs) among pharmacists for provision of Estradiol hemihydrate 10 micrograms vaginal tablets in a community pharmacy setting
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  To evaluate whether the additional risk minimisation measures (Pharmacy Guide, Pharmacy Checklist) are effective in enabling pharmacists to make appropriate decisions to supply Gina to consumers based upon pre-defined criteria.
• Study status:
  Finalised

Research institutions and networks

Institutions

Novo Nordisk

Study timelines

Date when funding contract was signed

Actual: 22/02/2023

Study start date

Actual: 25/07/2023

Date of final study report

Actual: 31/01/2024

Study protocol

Initial protocol

Gina NIS Protocol v6 eu-pas-reg Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)