First-in-human safety and ease-of-use test of 400 mg vaginal Progesterone Callavid for luteal phase insufficiency
First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency
This tests a new 400 mg vaginal progesterone device called Callavid to see if it is safe, easy to use, and delivers progesterone for women with luteal phase insufficiency.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Calla Lily Clinical Care Ltd Industry-sponsored |
| Locations | 1 site (Coventry) |
| Trial ID | NCT07136922 on ClinicalTrials.gov |
What this trial studies
This randomized, open-label, crossover Phase I trial compares a 400 mg progesterone drug-device combination (Callavid) worn for 2 or 3 hours with standard Cyclogest 400 mg pessaries in non-pregnant women with luteal phase insufficiency. The trial focuses on safety and tolerability, collects adverse event data including allergic, gastrointestinal, and neurological symptoms, and measures serum progesterone levels after each formulation. User acceptability and the practical ability of participants to place and use the Callavid device are recorded and compared with pessaries. Participants are adults aged 18–45 with a clinical diagnosis of luteal phase insufficiency who can attend the study site for visits.
Who should consider this trial
Good fit: Non-pregnant women aged 18–45 with clinically diagnosed luteal phase insufficiency who have had at least one prior miscarriage, can consent in English, and can attend clinic visits are ideal candidates.
Not a fit: Women who are pregnant or breastfeeding, have contraindications to progesterone or its excipients, cannot consent in English, or cannot attend the study visits are unlikely to receive benefit or be eligible.
Why it matters
Potential benefit: If successful, this device could offer a more comfortable and user-friendly way to deliver vaginal progesterone with reliable hormone levels.
How similar studies have performed: Vaginal progesterone preparations like Cyclogest are commonly used and have evidence supporting luteal support, but the Callavid drug-device combination itself is novel and is being tested in humans for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female sex * Clinical diagnosis of luteal phase insufficiency on the basis of one of the following: * Spotting before first day of heavy menstrual bleeding * Short time between ovulation and menstruation * Symptoms of progesterone insufficiency * Aged 18 - 45 years * Experienced at least one previous miscarriage Exclusion Criteria: * Positive pregnancy test * Currently breastfeeding * Allergies or contraindications to excipients / progesterone pessaries * Current or history of previous condition where hormone treatments are contraindicated e.g. breast cancer * Individuals who lack capacity to consent to the trial * Individuals who have an inability to comply with the trial procedures (e.g. cannot attend hospital for trial visits) * Inability to understand English
Where this trial is running
Coventry
- University Hospitals Coventry & Warwickshire NHS Trust — Coventry, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Siobhan Quenby
- Email: s.quenby@warwick.ac.uk
- Phone: +442476964000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.