FREEDOM

• Research type

  Research Study

• Full title

  First in woman safety and ease of use assessment of 400mg progesterone Callavid in women with luteal phase progesterone insufficiency

• IRAS ID

  1008895

• Contact name

  Violet Matthews

• Contact email

  freedomstudyoffice@uhcw.nhs.uk

• Sponsor organisation

  Calla Lily Clinical Care Ltd

• ISRCTN Number

  ISRCTN82163970

• Clinicaltrials.gov Identifier

  NCT07136922

• Research summary

  FREEDOM is a Phase I, first in human randomised control trial to assess the safety of a new vaginal 400mg progesterone drug-device combination product called 400mg progesterone Callavid.

• REC name

  HSC REC B

• REC reference

  25/NI/0165

• Date of REC Opinion

  10 Feb 2026

• REC opinion

  Further Information Favourable Opinion