Luteal Phase InsuffiencyPhase 1FREEDOMNCT07136922
First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency
A Phase 1 study testing 400mg progesterone Callavid - 2hr wear, Cyclogest 400 mg and 400mg progesterone Callavid - 3hr wear in people with Luteal Phase Insuffiency and Progesterone Delivery, run by Calla Lily Clinical Care Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Luteal Phase Insuffiency, Progesterone Delivery
- What is being tested?
- 400mg progesterone Callavid - 2hr wear, Cyclogest 400 mg and 400mg progesterone Callavid - 3hr wear
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Apr 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, CV2 2DX
Violet Matthews Trial Manager, +44 2476 966197, freedomstudyoffice@uhcw.nhs.uk
About this study
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:
- 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)?
- What is usability experience for patients using the Callavid drug-device combination compared to pessaries / suppositories (i.e. Cyclogest 400 mg)?
- 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?
- Conditions
- Luteal Phase Insuffiency, Progesterone Delivery
- Being tested
- 400mg progesterone Callavid - 2hr wear, Cyclogest 400 mg, 400mg progesterone Callavid - 3hr wear
- Keywords
- progesterone delivery, progesterone, vaginal drug delivery, callavid, cyclogest, women's health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400mg progesterone Callavid - 2hr wearCombination product
400mg progesterone Callavid, 2 hour wear, twice daily for 7 days
Cyclogest 400 mgDrug
Cyclogest 400 mg pessary, twice daily for 7 days
400mg progesterone Callavid - 3hr wearCombination product
400mg progesterone Callavid, 3 hour wear, twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Callavid 2-hr first, Cyclogest second, Callavid 3-hr third | Active comparator | Participants are randomised to use Callavid first for 2 hour wear before crossing over to use Cyclogest. In the third round, participants receive Callavid again but for 3 hour wear. Receives: Combination Product: 400mg progesterone Callavid - 2hr wear; Drug: Cyclogest 400 mg; Combination Product: 400mg progesterone Callavid - 3hr wear |
| Cyclogest first, Callavid 2-hr second, Callavid 3-hr third | Active comparator | Participants are randomised to use Cyclogest first before crossing over to use Callavid for 2 hour wear. In the third round, participants receive Callavid again but for 3 hour wear. Receives: Combination Product: 400mg progesterone Callavid - 2hr wear; Drug: Cyclogest 400 mg; Combination Product: 400mg progesterone Callavid - 3hr wear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events recorded from 400 mg progesterone Callavid
Any grade of adverse events, specifically allergy, gastrointestinal (bloating, constipation), neurological (headache, drowsiness, euphoria) according to Common Terminology Criteria for Adverse Events (CTCAE).
Measured: From treatment up to 24 hours after the last dose
Secondary outcomes (4)
PROMIS Anxiety questionnaire
PROMIS short 4-item anxiety fear instrument
Measured: Day 1 and day 7 of treatment in each round (3 rounds total)
Acceptability questionnaires
User acceptability questionnaires on 400mg progesterone Callavid
Measured: Day 1 and day 7 of treatment in each round (3 rounds total)
Semi-structured user experience interviews
Semi-structured interviews with participants after completion of the crossover rounds.
Measured: day 7
Delivery of vaginal progesterone into the blood at 2 hour and 3 hour wear
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.
Measured: Multiple time points on Day 1 and Day 7 of each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start20 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Luteal Phase InsuffiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The trial consists of three rounds, conducted over three consecutive menstrual cycles. Participants are randomised to receive either Cyclogest 400mg progesterone pessary in the first round, crossing over to 400mg progesterone Callavid (administered for 2 hours) in the second round, or 400mg progesterone Callavid (administered for 2 hours) in the first round crossing over to Cyclogest 400mg progesterone pessary in the second round. The third round is to investigate the safety of 400mg progesterone Callavid when administered for 3 hours. This would inform us on the safety of the additional hour of wear time. Each arm will complete the third round following the first two crossover rounds.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calla Lily Clinical Care Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust, University of Warwick
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136922
- Sponsor's protocol ID
- SQ641924
- Acronym
- FREEDOM
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for anonymised participant data should be directed to the Sponsor at clinicaltrials@callali.ly. All requests will be considered by Institution Governance and a data sharing agreement might be required.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency
- ClinicalTrials.gov ID
- NCT07136922
- Acronym / sponsor ID
- FREEDOM / SQ641924
- Conditions
- Luteal Phase Insuffiency, Progesterone Delivery
- Keywords
- progesterone delivery, progesterone, vaginal drug delivery, callavid, cyclogest, women's health
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Calla Lily Clinical Care LtdIndustry (pharma, biotech, devices)
- Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust, University of Warwick
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)?
- What is usability experience for patients using the Callavid drug-device combination compared to pessaries / suppositories (i.e. Cyclogest 400 mg)?
- 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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial consists of three rounds, conducted over three consecutive menstrual cycles. Participants are randomised to receive either Cyclogest 400mg progesterone pessary in the first round, crossing over to 400mg progesterone Callavid (administered for 2 hours) in the second round, or 400mg progesterone Callavid (administered for 2 hours) in the first round crossing over to Cyclogest 400mg progesterone pessary in the second round. The third round is to investigate the safety of 400mg progesterone Callavid when administered for 3 hours. This would inform us on the safety of the additional hour of wear time. Each arm will complete the third round following the first two crossover rounds.
| Arm | Type | Receives |
|---|---|---|
| Callavid 2-hr first, Cyclogest second, Callavid 3-hr third | Active comparator | Combination Product: 400mg progesterone Callavid - 2hr wear, Drug: Cyclogest 400 mg, Combination Product: 400mg progesterone Callavid - 3hr wearParticipants are randomised to use Callavid first for 2 hour wear before crossing over to use Cyclogest. In the third round, participants receive Callavid again but for 3 hour wear. |
| Cyclogest first, Callavid 2-hr second, Callavid 3-hr third | Active comparator | Combination Product: 400mg progesterone Callavid - 2hr wear, Drug: Cyclogest 400 mg, Combination Product: 400mg progesterone Callavid - 3hr wearParticipants are randomised to use Cyclogest first before crossing over to use Callavid for 2 hour wear. In the third round, participants receive Callavid again but for 3 hour wear. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 400mg progesterone Callavid - 2hr wear400mg progesterone Callavid, 2 hour wear, twice daily for 7 days | Combination product | Callavid 2-hr first, Cyclogest second, Callavid 3-hr third, Cyclogest first, Callavid 2-hr second, Callavid 3-hr third |
| Cyclogest 400 mgCyclogest 400 mg pessary, twice daily for 7 days | Drug | Callavid 2-hr first, Cyclogest second, Callavid 3-hr third, Cyclogest first, Callavid 2-hr second, Callavid 3-hr third |
| 400mg progesterone Callavid - 3hr wear400mg progesterone Callavid, 3 hour wear, twice daily for 7 days | Combination product | Callavid 2-hr first, Cyclogest second, Callavid 3-hr third, Cyclogest first, Callavid 2-hr second, Callavid 3-hr third |
Primary outcome
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).
4 secondary outcomes
PROMIS Anxiety questionnaire
Time frame: Day 1 and day 7 of treatment in each round (3 rounds total)
Acceptability questionnaires
Time frame: Day 1 and day 7 of treatment in each round (3 rounds total)
Semi-structured user experience interviews
Time frame: day 7
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. Requests for anonymised participant data should be directed to the Sponsor at clinicaltrials@callali.ly. All requests will be considered by Institution Governance and a data sharing agreement might be required.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 400mg progesterone Callavid - 2hr wear, Cyclogest 400 mg and 400mg progesterone Callavid - 3hr wear in people with Luteal Phase Insuffiency and Progesterone Delivery, run by Calla Lily Clinical Care Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siobhan Quenby (+442476964000, s.quenby@warwick.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events recorded from 400 mg progesterone Callavid (time frame: From treatment up to 24 hours after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.