NCT07136922 First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency
| NCT ID | NCT07136922 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Calla Lily Clinical Care Ltd |
| Condition | Luteal Phase Insuffiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-04-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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?
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07136922 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Luteal Phase Insuffiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07136922 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07136922 currently recruiting?
Yes, NCT07136922 is actively recruiting participants. Contact the research team at s.quenby@warwick.ac.uk for enrollment information.
Where is the NCT07136922 trial being conducted?
This trial is being conducted at Coventry, United Kingdom.
Who is sponsoring the NCT07136922 clinical trial?
NCT07136922 is sponsored by Calla Lily Clinical Care Ltd. The trial plans to enroll 20 participants.