Status:
NOT_YET_RECRUITING
First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency
Lead Sponsor:
Calla Lily Clinical Care Ltd
Collaborating Sponsors:
University Hospitals Coventry and Warwickshire NHS Trust
University of Warwick
Conditions:
Luteal Phase Insuffiency
Progesterone Delivery
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
The aim of this clinical trial is to assess safety of a new vaginal 400mg progesterone drug-device combination product in a first in human trial. Additionally, it aims to assess user acceptability and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07136922
Start Date
December 1 2025
End Date
August 1 2027
Last Update
August 22 2025
Active Locations (1)
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1
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, United Kingdom, CV2 2DX