NEW STUDY ANNOUNCEMENT

Menstrual Pain Study

DO YOU SUFFER FROM MENSTRUAL PAIN?

If so, you could help assess a new product in a medical study to investigate treatment of menstrual pain and discomfort.

Check your eligibility here

If you experience symptoms of menstrual pain and discomfort, you could help with this research.

Thank you for your interest in RDC Clinical’s study into the effectiveness of a new palmitoylethanolamide (PEA) and resveratrol product. These ingredients have previously been researched for their pain-relieving, anti-oxidant and anti-inflammatory properties. To help with this study, we’re looking for females aged between 18 and 50, with a regular menstrual period who experience menstrual pain.

Remote participation over approximately 4 months

So that we can scientifically measure the product’s effectiveness, you would be required to take part in several assessments over 4 consecutive menstrual periods. To make the timing of participation as convenient as possible to you, we are recruiting on a rolling basis, which means that your start date is flexible.

This study is being conducted by phone interviews and online forms, so you can participate from anywhere in Australia.

If you’d like to apply to take part in this study, we’d love to hear from you. More information is below, the eligibility & registration form is on this page.

About the product you’ll help assess…

As part of the study, you will be issued with your study product to take daily for 3 months.

The investigational product is a combination of a bioactive molecule palmitoylethanolamide (PEA), with reported health benefits, and resveratrol is a natural compound produced by several plants as a response to injury. These compounds have been well researched for their pain-relieving, anti-inflammatory, anti-oxidant and anti-aging properties. Similar combinations of these products have shown efficacy in treating endometriosis-related pain in past studies. 

PEA and resveratrol are both well tolerated and currently safely in use in Australia. 

The aim of this study is to assess the effectiveness of palmitoylethanolamide (PEA) and resveratrol compared to a placebo for improving menstrual pain and discomfort.

As this study is placebo controlled, you may or may not be taking the active product.  50% of the study group will be taking a placebo (an inactive substance). However, if you are found to have been on placebo during the study, you will be offered the active product after your participation has ended.

About the study you’ll take part in…menstrual pain.

The study will involve approximately 120 menstruating adult women who are experiencing symptoms of menstrual pain and discomfort.

Starting the Study: Following enrolment, you will be allocated and sent your study product. Before you start taking your trial product, you will be required to record baseline information for one menstrual period. This will involve:

  • A pre-menstrual symptom questionnaire on Day 1 (first day of bleeding)
  • A pain score and menstrual symptom questionnaire on each day of your menstrual period.

Once you have completed and scored your first menstrual period, you can start to take the supplied trial product daily as directed.

During the Study: You will take the trial product daily as directed until you have completed a further 3 menstrual periods (approximately 3 months). As with the baseline information, you will be required to complete a pre-menstrual symptom questionnaire on Day 1, and a daily questionnaire during each period. If required, you may take additional pain medication; however, this must be recorded in your daily questionnaire.

All data will be entered online using your unique Participant ID.  There is no need to attend any interviews or appointments in person.

The information we collect during the study, including if you took any other additional pain medication, will enable the investigators to assess the product’s effectiveness on improving menstrual pain and discomfort. 

If you’re a woman experiencing symptoms of menstrual pain, aged between 18 and 50, and would like to help, we’d love to hear from you. Please register your interest by answering the questionnaire and completing the form on this page… we’ll then get in touch to screen you for suitability.

Check if you can apply…

Are you…

  • A menstruating female aged between 18 and 50?
  • Experiencing pain during your menstrual periods?
  • A non-smoker?
  • Generally healthy and a BMI of between 18.5-35? (Please use the BMI calculator on this page)

And…

  • Have a regular menstrual cycle of between 21-35 days?
  • Not suffering from endometriosis, adenomyosis, uterine fibroids, infection or any other such underlying cause for menstrual pain?
  • Not suffering from any unstable or serious illness (eg kidney, liver, GIT, heart condition, diabetes, lung condition, malignancy) or any chronic disease in the last 6 months?
  • Not using any long-term medication related to menstrual-related or general pain?

In order to satisfy the full inclusion criteria, potential participants must undergo an initial telephone interview conducted by our trial investigators before partaking in the study 

Check your BMI…

 

Ethics approval & privacy… you’ll be in safe, professional hands.

This RDC Clinical study has been approved by the Bellberry Human Research Ethics Committee under Approval Number: 2020-07-674-A-1.

Trained Trial Co-ordinators will supervise your progress throughout the study. Any of your personal information collected during the study will be kept in the strictest confidence and no identifying information is ever published.

About the location of the study...you'll attend clinic appointments

Our clinic is located in Doggett Street, Newstead, Brisbane.

We are walking distance from the Commercial Road Ferry Terminal & local buses, and a quick 10-minute walk from Bowen Hills train station. We also have onsite visitor parking available.