RecruitingPHASE1INTERVENTIONAL

First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency

This study is looking into a new product called Progesterone Callavid, a vaginal drug that delivers 400mg of progesterone. It's for women aged 18-45 who have a condition called luteal phase insufficiency and have had at least one miscarriage. The main goals are to find out if this new product is safe and well-tolerated, and how easy it is for women to use compared to current progesterone pessaries (like Cyclogest). Researchers also want to see how the new Callavid system affects progesterone levels in the body differently from Cyclogest. This information will help them design future studies and understand how well the new product works.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Calla Lily Clinical Care Ltd

Enrolment target

Start

01 Apr 2026

Estimated completion

01 Aug 2026

Luteal Phase Insuffiency Progesterone Delivery

What is this study about?

This study is focused on a new way to deliver a hormone called progesterone, specifically for women who have a condition called luteal phase insufficiency. This condition means that after ovulation, the body might not make enough progesterone, which can sometimes make it harder to maintain a pregnancy. The new product, called Progesterone Callavid, is a vaginal device designed to deliver a dose of 400mg of progesterone.

The main purpose of this study is to see if this new Callavid device is safe and if it causes any unwanted side effects when used for the first time by people. Researchers will also be checking how easy it is for women to use and if they find it comfortable. They'll be comparing it to a common progesterone treatment called Cyclogest to see how the body absorbs and uses the progesterone from Callavid.

By understanding the safety, ease of use, and how well progesterone is absorbed from the Callavid device, researchers can decide if it's a promising option for women with luteal phase insufficiency. This early stage of research is really important to make sure new treatments are safe and have the potential to help patients in the future.

Key takeaways

Tests a new progesterone delivery device (Callavid) for luteal phase insufficiency.
Compares Callavid to an existing treatment (Cyclogest).
Focuses on safety, ease of use, and how the body absorbs progesterone.
For women aged 18-45 with a history of miscarriage.
Participation involves using both treatments and regular hospital visits for monitoring.

Who may be eligible?

This study is looking for women between the ages of 18 and 45. To be considered, you should have been diagnosed with luteal phase insufficiency. This means you might experience spotting before your period starts, have a short time between when you ovulate and when your period begins, or have other symptoms that suggest you're not making enough progesterone. You also need to have experienced at least one miscarriage.

There are certain reasons why you wouldn't be able to join the study. For example, if you are pregnant or currently breastfeeding, you won't be able to take part. Also, if you have any allergies to progesterone or similar medications, or if you have a medical condition where hormone treatments are usually not recommended (like certain types of cancer), you wouldn't be eligible. You also need to be able to understand English and attend all necessary hospital visits for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged between 18 and 45?
Have you been diagnosed with luteal phase insufficiency?
Have you experienced at least one miscarriage?
Are you not currently pregnant or breastfeeding?
Do you not have allergies to progesterone or conditions that prevent hormone treatment?
Can you understand English and attend all study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be trying out both the new Callavid device and the existing Cyclogest treatment at different times. The study is set up so you'll switch between the treatments, allowing researchers to compare them directly in you. You will be asked to wear the Callavid device for either 2 hours or 3 hours, depending on what the study assigns.

Throughout the study, you'll have several visits to the hospital or clinic. These visits will involve blood tests to measure your progesterone levels and check for any side effects. You'll also be asked to share your experience using the treatments, including how comfortable and easy they were. The exact number of visits and the total duration aren't specified but expect a commitment over a period that allows for trying out each treatment and follow-up assessments.

Potential risks and benefits

Taking part in this study may offer some potential benefits by contributing to the development of new treatments for luteal phase insufficiency. While you might not directly benefit, your participation helps researchers understand the safety and effectiveness of the new Callavid device. Like any medication, there are potential risks, including side effects such as allergic reactions, stomach issues (like bloating or constipation), headaches, or feeling drowsy or unusually happy. All known side effects will be explained to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Coventry & Warwickshire NHS Trust
Verified postcode
Coventry, United Kingdom· Recruiting

Common questions

What is luteal phase insufficiency?

It's when your body might not make enough progesterone after ovulation, which can affect the lining of your womb.

What is progesterone?

Progesterone is a natural hormone that helps prepare your body for pregnancy and maintain it.

What is the new Callavid device?

It's a new vaginal product designed to deliver progesterone, and this study is testing its safety and how it works.

Will I receive treatment for my condition during the study?

The study involves using progesterone treatments, both the new device and an existing one, to understand their effects.

What kind of side effects might I experience?

Possible side effects include allergic reactions, stomach problems, headaches, or feeling tired or unusually happy. These will be carefully monitored.

How to find out more

Siobhan Quenby

s.quenby@warwick.ac.uk +442476964000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.