Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS THE INFLUENCE OF ESTETROL (E4) ON HAIR GROWTH PARAMETERS IN POSTMENOPAUSAL WOMEN WITH FEMALE PATTERN HAIR LOSS (PILOT STUDY)

This study is investigating a new medication called estetrol (E4) for postmenopausal women who have hair thinning. It’s a ‘phase 2’ study, which means it’s still early stage, focusing on understanding if the medicine works and if it's safe. Women will either receive the active medication or a dummy pill (placebo) to fairly compare the effects. Researchers will measure changes in hair growth, including the number and thickness of hairs, over 22 weeks. They will also carefully check for any side effects and monitor women's general health, including any changes to their womb lining or bleeding patterns. The aim is to see if E4 could be a new way to help with hair thinning in this group of women.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Estetra

Enrolment target

Start

17 Oct 2024

postmenopausal women with vasomotor menopausal symptoms

What is this study about?

This study is designed for women who have gone through menopause and are experiencing thinning hair, also known as female pattern hair loss. It's a 'phase 2' study, which means it’s an important step in researching a new medicine. The main goal is to find out if a drug called estetrol (E4) can help improve hair growth and make it thicker.

Researchers are comparing E4 to a 'placebo', which is a dummy pill that looks exactly like the real medicine but contains no active drug. This allows them to see if any changes are truly due to E4 or if they might happen anyway. The study also pays close attention to safety, checking for any side effects and monitoring overall health.

We know that many women experience changes, including hair thinning, after menopause. Understanding if medicines like E4 can safely and effectively help with these changes is really important for improving women's health and quality of life. This study hopes to provide valuable information about a potential new treatment option.

Key takeaways

This study evaluates a potential new drug (E4) for hair thinning in postmenopausal women.
It aims to see if E4 improves hair growth and is safe to use.
Participants will receive either E4 or a dummy pill (placebo) for 22 weeks.
Regular check-ups and health monitoring are part of the study.
It's a 'phase 2' study, meaning it's an early step in finding new treatments.
You can leave the study at any time if you change your mind.

Who may be eligible?

To join this study,您 must be a woman who has already gone through menopause. This means your periods have stopped for at least 12 months.

Even though the age range says 18 years to any age, it is specifically designed for women who are postmenopausal. You should also be experiencing thinning hair (female pattern hair loss).

The study will have other specific health requirements that you will need to discuss with the study team to make sure it's the right fit for you.

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?
Have you gone through menopause (no period for 12 months)?
Are you experiencing hair thinning on your scalp?
Are you able to attend regular clinic visits for 22 weeks?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the study drug (E4) or a placebo pill to take. You won't know which one you're getting, and neither will the study doctor, to keep the results fair. You'll have regular visits to the clinic over a period of 22 weeks. During these visits, the study team will take measurements of your hair, perform physical examinations, check your vital signs like blood pressure, and take blood samples. They will also monitor your overall health very closely, including looking at your womb lining with a special scan. There will be careful follow-up throughout the study period to track any changes or side effects, and your participation will last for approximately 22 weeks.

Potential risks and benefits

Taking part in a study like this could potentially benefit you by improving your hair growth if the study drug works. You would also be helping to advance medical knowledge that could help countless others in the future. However, there's no guarantee the treatment will work for you, and like all medicines, E4 may have side effects. These could include changes to the womb lining, vaginal bleeding, or other effects on your body. The study team will monitor you closely for any unwanted effects. 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.

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Unverified
Germany

Common questions

What is 'postmenopause'?

Postmenopause is when you haven't had a period for 12 straight months. It means your body has completed the transition through menopause.

What is 'female pattern hair loss'?

This is a common type of hair thinning in women, where hair on the top and crown of the head becomes thinner, often starting with a widening part line.

What does 'double-blind' mean?

It means neither you nor the study doctor knows if you're getting the actual medicine or a dummy pill (placebo). This helps make the study results fair and unbiased.

What is 'estetrol (E4)'?

Estetrol (E4) is a type of hormone. In this study, researchers are looking at whether it can help with hair growth in postmenopausal women.

How long will the study last for me?

If you join, your active participation in the study will last for approximately 22 weeks.