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New vaginal progesterone device tested for safety and ease of use

NCT ID NCT07136922

Symptom relief Sponsor: Calla Lily Clinical Care Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This early-stage trial tests a new vaginal product (Callavid) that delivers 400mg of progesterone to women with luteal phase insufficiency, a condition that can affect fertility. The study compares it to an existing pessary to see if it is safe, well-tolerated, and easy to use. 20 non-pregnant women aged 18-45 with a history of miscarriage will participate in a crossover design, using both products and reporting their experiences.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

progesterone resistance

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Luteal phase insuffiency Progesterone delivery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospitals Coventry & Warwickshire NHS Trust

    RECRUITING

    Coventry, CV2 2DX, United Kingdom

    Contact Email: •••••@•••••