Calla Lily Clinical Care, a women’s health-focused medical technology company, has announced dosing of the first patients in the FREEDOM clinical trial. The study, funded by the National Institute for Health and Care Research (NIHR), is evaluating 400mg progesterone Callavid in patients diagnosed with luteal phase insufficiency, a condition where progesterone levels may be too low to support early pregnancy, increasing risk of infertility and recurrent miscarriage.
Callavid is positioned to become the world’s first drug-device combination product to support treatment of threatened miscarriage, as well as luteal phase support as part of Assisted Reproductive Technologies, including In-Vitro Fertilisation (IVF). The Government’s Renewed Women’s Health Strategy for England cites estimates ranging from 120,000 to 250,000 cases of miscarriage per year in the UK1. Administering 400mg micronised progesterone twice daily is recommended by the National Institute for Health and Care Excellence (NICE) for women who have suffered a previous miscarriage and experience bleeding during early pregnancy, known clinically as ‘threatened miscarriage’.
Current delivery methods rely on self-administration using pessaries (vaginal suppositories), which are prone to leakage and may result in uncertain placement and movement during use. These limitations can reduce the efficiency and consistency of drug absorption, potentially compromising delivery of the intended dose, and patients are regularly advised to lie horizontal for extended periods following each administration. Callavid’s patented leak-free, tampon-like design addresses the challenges associated with administration of vaginal therapeutics, enabling cleaner, more comfortable delivery of medicines and hormones.
The FiRst in human safEty and Ease of use assessment of 400mg progesterone CallaviD in wOMen with luteal phase insufficiency (FREEDOM) study is led by Clinical Chief Investigator, Professor Siobhan Quenby MBE, a world-leading authority on miscarriage and preterm birth, and an Honorary Consultant at University Hospitals Coventry and Warwickshire (UHCW) NHS Trust. The trial is funded by the NIHR and run collaboratively with the Trial Management Unit at UHCW. By evaluating safety, user acceptability and progesterone absorption, the study aims to provide evidence of improved usability in self-administration, demonstrating the capabilities of the easy-to-use Callavid vaginal delivery platform for maximising adherence and overall patient wellbeing.
Professor Siobhan Quenby MBE, chief investigator, FREEDOM trial, said: “Through my clinical practice, I see the difficulties patients face with existing vaginal progesterone products at an already very stressful time. Callavid offers a promising new solution to ensure delivery of the correct progesterone dosage and give women greater confidence in their treatment. There is genuine excitement among both clinicians and patients at the prospect of Callavid progressing into clinical trials.”
