University Hospitals Coventry & Warwickshire NHS Trust
Coventry, CV2 2DX, United Kingdom
Location status: Recruiting
Recruiting
NCT Number: NCT07136922
First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency
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?
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
400mg progesterone Callavid - 2hr wear
Combination Product400mg progesterone Callavid, 2 hour wear, twice daily for 7 days
Cyclogest 400 mg
DrugCyclogest 400 mg pessary, twice daily for 7 days
400mg progesterone Callavid - 3hr wear
Combination Product400mg progesterone Callavid, 3 hour wear, twice daily for 7 days
Primary outcomes
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Adverse events recorded from 400 mg progesterone Callavid
Time frame: From treatment up to 24 hours after the last dose
Any grade of adverse events, specifically allergy, gastrointestinal (bloating, constipation), neurological (headache, drowsiness, euphoria) according to Common Terminology Criteria for Adverse Events (CTCAE).
Secondary outcomes
-
PROMIS Anxiety questionnaire
Time frame: Day 1 and day 7 of treatment in each round (3 rounds total)
PROMIS short 4-item anxiety fear instrument
-
Acceptability questionnaires
Time frame: Day 1 and day 7 of treatment in each round (3 rounds total)
User acceptability questionnaires on 400mg progesterone Callavid
-
Semi-structured user experience interviews
Time frame: day 7
Semi-structured interviews with participants after completion of the crossover rounds.
-
Delivery of vaginal progesterone into the blood at 2 hour and 3 hour wear
Time frame: Multiple time points on Day 1 and Day 7 of each treatment
The serum progesterone levels at time 0, 3- and 6-hour after the first dose on day 1 and the thirteenth dose which is on day 7 each round of treatment are measured. Progesterone levels are measured for both 400 mg progesterone Callavid and 400 mg Cyclogest.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Calla Lily Clinical Care Ltd
Industry
Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust
- University of Warwick
Registry information
Acronym: FREEDOM
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Aug 22, 2025
- Registry last updated
- Apr 15, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.