First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Lut… (NCT07136922) | Clinical Trial Compass
RecruitingPhase 1
First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency
United Kingdom20 participantsStarted 2026-04
Plain-language 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 ability to deliver progesterone. This Phase I trial is a randomised open-label first-in-human crossover trial, recruiting participants who are non-pregnant with luteal phase insufficiency. The main questions it aims to answer are:
1. What are the safety and tolerability profiles of the two progesterone formulations (400mg Progesterone Callavid vs. Cyclogest 400 mg), including the incidence of adverse events (if any) such as allergic reactions, gastrointestinal symptoms (e.g. bloating, constipation), and neurological effects (e.g. headache, drowsiness, euphoria)?
2. What is usability experience for patients using the Callavid drug-device combination compared to pessaries / suppositories (i.e. Cyclogest 400 mg)?
3. How do serum progesterone levels vary within participants when using 400 mg progesterone delivered via the Callavid drug-device combination compared to Cyclogest 400 mg, and what are the implications of this variability for dose-response relationships and future trial design?
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events recorded from 400 mg progesterone Callavid
Timeframe: From treatment up to 24 hours after the last dose