Calla Lily Clinical Care, a UK women’s health medtech company, has dosed the first patients in the FREEDOM clinical trial evaluating its Callavid intravaginal drug delivery platform for progesterone administration in patients with luteal phase insufficiency – a condition where low progesterone levels increase the risk of infertility and recurrent miscarriage.
The NIHR-funded trial is led by Professor Siobhan Quenby MBE, and run in collaboration with University Hospitals Coventry and Warwickshire NHS Trust. It will evaluate safety, user acceptability, and progesterone absorption.
Callavid addresses a practical but significant problem with current progesterone delivery. NICE recommends 400mg micronised progesterone twice daily for women with a previous miscarriage who experience early pregnancy bleeding, but existing vaginal pessaries are prone to leakage and uncertain placement, potentially compromising dose delivery. Patients are regularly advised to lie down for extended periods after each administration. Callavid’s patented tampon-like design is leak-free and designed for cleaner, more comfortable self-administration.
“Through my clinical practice, I see the difficulties patients face with existing vaginal progesterone products at an already very stressful time,” said Professor Quenby. “Callavid offers a promising new solution to ensure delivery of the correct progesterone dosage and give women greater confidence in their treatment.”
“As a physician and entrepreneur, I believe we have a responsibility to create more effective, patient-centered solutions in women’s health,” said co-founder and chair Dr. Lara Zibners. “Having been through seven rounds of IVF myself, I have experienced how difficult progesterone treatment can be, and I am proud to be advancing an innovation shaped by both medical insight and lived experience.”
