A new progesterone delivery device called Callavid, resembling a tampon, is being trialed to overcome the discomfort and anxiety associated with traditional pessaries for women with luteal phase insufficiency, a leading cause of miscarriage.
A groundbreaking medical device resembling a tampon is being developed to assist women who have experienced miscarriage by improving progesterone delivery. Progesterone is a crucial hormone in early pregnancy, as it thickens the uterine lining to support embryo implantation.
Approximately 400,000 women in the UK suffer from luteal phase insufficiency, a condition where either insufficient progesterone is produced or the uterus does not respond properly, leading to infertility and recurrent miscarriage. Current treatment involves twice-daily vaginal insertion of progesterone pessaries.
A major trial, the PRISM study published in the New England Journal of Medicine in 2019, showed that 400mg progesterone pessaries twice daily led to a modest reduction in miscarriage for women with one or two prior losses, and a substantial improvement in live birth rates (72% vs 57% with placebo) for those with three or more miscarriages. Despite their efficacy, pessaries are poorly tolerated.
Professor Siobhan Quenby of the University of Warwick notes that many women dislike the treatment due to significant vaginal discharge-up to 10ml per dose-which causes anxiety, especially in those with miscarriage history who fear it signals another loss. The uncertainly about whether the discharge contains the hormone also makes women worry they are not receiving the full dose. To manage leakage, women often rise early to remain supine after the first morning dose, disrupting daily routines.
Additionally, improper placement can reduce absorption or cause the pessary to slip out. Injections are an alternative but are typically private, painful, and carry infection risk. The new device, named Callavid, is designed to address these issues. It has the size and shape of a regular tampon, remains inside the body for two hours while progesterone is released, and features an external absorbent disc to prevent leaks.
Made primarily of organic cotton, its tip is coated with a progesterone and vegetable fat mixture that melts after insertion. A removal string allows easy extraction. Callavid is currently undergoing a trial at University Hospitals Coventry and Warwickshire NHS Trust, led by Professor Quenby and funded by the National Institute for Health and Care Research. The study involves 20 women with luteal phase insufficiency and at least one miscarriage.
Participants will use Callavid for one week and then a standard pessary during another month, both delivering 400mg progesterone twice daily. Blood tests will measure progesterone levels before and after each treatment week. Women will also complete comfort questionnaires and wear sanitary pads to quantify any leakage. Success in the trial could lead to commercial availability by the end of next year.
Beyond miscarriage prevention, the manufacturer envisions using Callavid for other progesterone indications, such as stopping bleeding in early pregnancy, preventing preterm birth by reducing uterine contractions, and enhancing embryo implantation in IVF cycles. The device promises greater efficacy, simpler application, and reduced anxiety compared to pessaries
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