RecruitingPHASE2INTERVENTIONAL

A Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.

This study aims to discover if certain pollen extracts can help ease common menopause symptoms in healthy women. Many women experience symptoms like hot flushes, sweating, sleep issues, or mood changes during menopause, and this research explores a new approach to managing them. Participants will be given one of two types of pollen extract or a placebo (a dummy treatment). Over 36 weeks, researchers will regularly check if their symptoms improve. By comparing the groups, the study hopes to understand if these pollen extracts can make a real difference in how women experience menopause. This is a "Phase 2" study, meaning it's an earlier step to see if the treatment works and is safe.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Graminex LLC

Enrolment target

120

Start

29 Oct 2025

Estimated completion

01 Aug 2026

Menopausal Women

What is this study about?

Many women go through menopause, and it can bring uncomfortable symptoms like hot flushes, night sweats, difficulty sleeping, or changes in mood. This particular study is looking into whether special extracts from pollen might help reduce these symptoms. Researchers are trying to find out if these pollen extracts are better at easing menopause symptoms compared to a 'dummy' treatment, known as a placebo.

To do this, women taking part in the study will be divided into three groups. One group will take a water-soluble pollen extract, another will take a lipid-soluble pollen extract, and the third group will receive the placebo. Over several months, everyone will regularly complete questionnaires to describe their symptoms. This helps the study team keep track of any changes.

The main goal is to see if there's a real difference in how much symptoms improve between the groups taking the pollen extracts and the group taking the placebo. This kind of research is important because it could lead to new ways for women to manage their menopausal symptoms, offering more choices for better comfort and well-being during this natural life stage.

Key takeaways

This study explores pollen extracts as a potential way to ease menopause symptoms.
It's for healthy women aged 45-60 who have already gone through menopause and have symptoms.
Participants will take either a pollen extract or a dummy treatment for 36 weeks.
The main goal is to see if pollen extracts reduce symptoms like hot flushes and sleep problems.
Participation involves regular visits and completing symptom questionnaires.
You have the right to withdraw from the study at any time.

Who may be eligible?

This study is looking for women aged between 45 and 60 years old who have already gone through menopause (meaning they haven't had a period for over a year). You should be experiencing at least some moderate menopausal symptoms, such as hot flushes or sweating, along with two or more other common symptoms like sleep problems, joint aches, mood changes, tiredness, or vaginal dryness.

To be eligible, you should also be generally healthy, with no unstable long-term health conditions. Your weight should be within a certain range (Body Mass Index between 18.5 and 34.9). You’ll need to be willing to keep your current lifestyle – including diet, exercise, and any medications – as consistent as possible throughout the study.

There are some reasons why you might not be able to join. For example, if you've had certain surgeries like a hysterectomy, or if you have severe allergies to bee products or pollen. If you have unstable heart conditions, uncontrolled diabetes or high blood pressure, certain digestive problems, or an ongoing severe mental health condition like anxiety or major depression, you would also not be able to take part. The study team will check your medical history carefully to make sure it's safe for you to participate.

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 between 45 and 60 years old?
Have you not had a menstrual period for over 12 months?
Do you experience moderate menopausal symptoms like hot flushes, sweating, and other troubles like sleep issues or mood changes?
Are you generally healthy, without unstable ongoing medical conditions?
Do you not have severe allergies to pollen or bee products?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of three groups: one taking a specific pollen extract, another taking a different pollen extract, or a third group taking a dummy treatment (placebo). You won't know which group you're in, and neither will the study team. You'll need to visit the clinic regularly over 36 weeks (about 8-9 months).

During these visits, you'll be asked to fill out questionnaires about your menopausal symptoms. This is how the researchers will keep track of how you're feeling and if your symptoms are changing. You’ll also have general health checks to ensure you remain well throughout the study. It’s important to take the study treatment regularly as instructed and to try and maintain your usual daily routines, like diet and exercise, as much as possible.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as gaining access to a new treatment that might help your menopausal symptoms. You'll also receive careful monitoring of your health throughout the study. However, there's no guarantee that you will receive the active pollen extract, or that it will be effective for you. There might also be unknown side effects from the pollen extracts, though these are usually explored in earlier study phases. You will be fully informed of any known risks before you agree to take part. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

KGK Science Inc.
Verified postcode
London, Canada· Recruiting

Common questions

What is pollen extract, and why is it being studied for menopause?

Pollen extracts are natural substances derived from pollen. They are being studied because some early research suggests they might help ease menopause symptoms for some women.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medication but contains no active ingredients. It helps researchers see if any improvements are due to the actual treatment or other factors.

Will I know if I'm taking the pollen extract or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know whether you are taking one of the pollen extracts or the placebo until after the study is complete, for accurate results.

How long will I need to be in the study?

The study involves regular participation and assessments over a period of 36 weeks, which is about 8 to 9 months.

What kind of symptoms are they looking at?

The study is mainly focused on common menopausal symptoms like hot flushes, sweating, sleep problems, joint aches, mood changes, tiredness, vaginal dryness, and changes in urinary or sexual function.

How to find out more

Erin Lewiss, PhD

elewis@kgkscience.com 1-226-242-4551 Official trial record

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