Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy of Vitex agnus-castus BNO 1095 (20 mg) in women with primary dysmenorrhea

This research is investigating a natural plant extract from chaste tree fruits, also known as Vitex agnus-castus, to see if it can relieve the pain associated with primary dysmenorrhea. Primary dysmenorrhea is the medical term for common period pain that isn't caused by another health condition. This study wants to find out if taking this extract can significantly lessen the severity of period cramps. It will also check if people need to take fewer other pain medicines while using the extract. This is a big study (Phase III) to confirm if this treatment works and is safe for women who experience painful periods.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Bionorica SE

Enrolment target

300

Start

20 Nov 2023

Primary Dysmenorrhea

What is this study about?

Imagine feeling a significant amount of period pain every month, making everyday activities difficult. This study is designed specifically for women who experience this kind of pain, known as 'primary dysmenorrhea.' This is common period pain that doesn't have another cause like endometriosis or fibroids. Researchers are trying to find new, effective ways to help manage this.

In this particular study, they are focusing on a plant-based treatment derived from chaste tree fruits, called Vitex agnus-castus. This extract has been used traditionally, and now scientists want to thoroughly test if it really helps. They will compare it to a 'placebo,' which looks exactly like the actual treatment but contains no active ingredients. This helps them understand if any improvements are genuinely from the chaste tree extract or just from the act of taking something.

The main goal is to see if women taking the chaste tree extract experience much less period pain *and* don't need to take more of their usual pain medicine. This is a "Phase III" study, which means it's one of the final steps before a treatment might become widely available, aiming to confirm its effectiveness and safety for many women.

Key takeaways

This study investigates a natural extract for common period pain.
It aims to see if chaste tree fruit extract can reduce pain without increasing other pain relief.
The study includes a placebo group to accurately test the extract's effects.
It's a large-scale study (Phase III) to confirm effectiveness and safety.
Only women aged 18 and over with primary dysmenorrhea are eligible.

Who may be eligible?

This study is for adult women, specifically those aged 18 years and older. There's no upper age limit mentioned, so older women might also be able to join.

To be considered, you must be a woman who experiences painful periods (primary dysmenorrhea). This study is only open to women, as its focus is on period pain.

It's important to note that if you have other known health conditions that cause period pain, you might not be suitable for this study. The researchers are looking for people whose painful periods are not linked to another medical issue.

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 an adult woman, 18 years or older?
Do you experience significant period pain that is not caused by another medical condition?
Are you able to regularly track your pain levels and any other medication you take?
Are you willing to potentially receive either the study treatment or a dummy pill (placebo)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the chaste tree fruit extract or an inactive dummy pill (placebo). You won't know which one you are taking. You'll likely be asked to keep a record of your period pain, probably using a scale to rate its intensity, and to track how much other pain relief medication you take during your period. Researchers will be especially interested in your pain levels during your period around the fifth cycle of the study compared to when you started. There will be regular check-ups or ways for the researchers to collect information from you over a period of time to see how you are responding to the treatment. The total length of your participation will be explained to you in detail.

Potential risks and benefits

Participating in this study might offer you the potential benefit of reduced period pain if you are assigned to the group receiving the active chaste tree extract. You would also be contributing to medical knowledge that could help many other women with painful periods in the future. However, there are potential risks, as with any medication, such as side effects from the chaste tree extract, though these are typically mild for this type of natural remedy. There's also a chance you might receive the placebo and therefore not experience any benefit from the study medication. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

—
Unverified
Sweden
—
Unverified
Austria
—
Unverified
Poland
—
Unverified
Czechia
—
Unverified
Hungary
—
Unverified
Germany

Common questions

What is primary dysmenorrhea?

It's the medical term for common period pain that isn't caused by another underlying health problem.

What is Vitex agnus-castus?

It's a natural plant extract, also known as chaste tree fruit, that is being tested for its potential to help with period pain.

What is a placebo?

A placebo is a dummy pill that looks exactly like the study medication but contains no active ingredients. It helps researchers understand if the real medicine is actually working.

Will I know if I'm getting the real treatment or the placebo?

No, you won't know whether you are receiving the active extract or the placebo. This is standard practice in studies to ensure the results are fair.

How long will I need to be in the study?

The exact duration of the study participation will be explained to you by the research team. It involves tracking your period pain over several cycles.