BACKGROUND AND STUDY AIMS

Dr. Jerilynn Prior and the UBC Centre for Menstrual Cycle and Ovulation Research (CeMCOR) are inviting teen and young adult women+ (of all genders) with problematic menstrual cramps to participate in a study comparing two ways of taking ibuprofen (brand names Advil©, Motrin© etc.) for menstrual cramps to see if we can decrease menstrual pain.

Menstrual cramps affect most young women+ although about a quarter report missing school or work because they are so painful.

Ibuprofen is the standard cramp treatment because it prevents formation of prostaglandins (the funny fatty acid hormones) that cause the contractions of the uterus we call “cramps”. Ibuprofen is taken as two (200 mg tablets) at the first hint of cramps. After that it is officially taken every 4-6 hours. However, some find this ineffective. We will see if a different way of taking ibuprofen is better at treating cramps.

Ibuprofen is available on pharmacy shelves so is quite safe for young people. Its most common side effect is heartburn which can be prevented if it is always taken with food.

PURPOSES OF THE STUDY

Our goal is to see if a different way of taking ibuprofen will be more effective for the pain of menstrual cramps than the standard way of taking it.

WHO CAN BE PART OF THIS STUDY?

You are not able to participate if:

• you are taking the Pill (combined hormonal contraceptives) or using a hormone-releasing IUD.
• you have had a past unwanted or harmful reaction to ibuprofen, you also are not eligible

WHAT DOES THE STUDY INVOLVE?

This study invites participants from Metro Vancouver to participate in a two-week randomized trial and two visits that will compare two ways of taking ibuprofen for menstrual cramps.

To take part in this study, you need to let us know by calling 604-875-5960 or emailing us at cycles.cemcor@ubc.ca.

• You will record the Daily Diary© for two weeks and the ibuprofen you take for the days you have cramps.
• We will give you 90 tablets of ibuprofen (provided by Pure Integrative Pharmacies), enough for at least six cycles.
• You will start recording on the Daily Diary© about a week before you guess your period will start.
• Whenever cramps start, you will start taking ibuprofen following the instructions on your ibuprofen bottle.
• After a week of recording in your new cycle (starting with Day 1, the first day of flow), you will return for a second visit.

Please bring 3 things to that visit:

Please Note: We will only be able to include your results if you complete the FINAL QUESTIONNAIRE (online and print version). It takes only 2-3 minutes.

PERKS OF PARTICIPATING IN THIS STUDY

WHEN IS THE STUDY STARTING AND HOW LONG IS IT?

• In April 2025. You will participate for 2-weeks, although we need you to come visit us twice.
• The Centre for Menstrual Cycle and Ovulation Research website (www.cemcor.ubc.ca) will let you know when we are done recruiting for this investigation, but possibly not before the end of 2025.
• We will send you an email telling you that you can access the study results as soon as they are available (since it takes time to clean and analyze the information).

BENEFITS OF PARTICIPATING IN THIS STUDY

By keeping the Daily Diary© and tracking your cramps you may learn a bit about your own body, and how you respond to ibuprofen. We are providing you with free ibuprofen for at least half a year. And we are offering a free menstrual cup and support in using it. Together we are learning something that may help all those with menstrual cramps.

POTENTIAL HARMS AND DISCOMFORTS

This study has been carefully reviewed and approved by UBC Clinical Research Ethics Board (CREB #H24-03415). We don’t expect anyone will have intense, unwanted ibuprofen effects. However, we are carefully tracking side-effects which will increase knowledge for the future.

STUDY FUNDING

This study is not funded by any agency or sponsor. Medical students at UBC are providing their time, skills and energy to create this study and to be its research assistants. Any other costs for this research (the person who will randomize you, and analyze results, those making ads, coordinating visits, and making sure you learn your own results) are supported by individual donations to CeMCOR. Ibuprofen is donated by Pure Integrative Pharmacy, creating the labelled bottles and counting out 90 pills and couriering these bottles to us.

STUDY INVESTIGATORS

• Jerilynn C. Prior MD – Endocrinology Professor and CeMCOR’s Scientific Director
• Sonia Shirin MD – CeMCOR Research Associate; randomization and statistics
• Dharani Kalidasan MSc – Basic Scientist and Coordinator
• Marshall Dahl MD – Endocrinologist; Head-UBC Division of Endocrinology – prescriptions
• Azita Goshtasebi MD – Women’s health expert; Canadian Family Physician; CeMCOR Scientific; Advisory Committee Member

Medical Student Researchers:

• Johnny Yip – Pharmacist and fourth year student, nearly ready to graduate
• Kate Fitzsimmons – Fourth year student also almost graduating
• Maya Geerts – Second year student
• Sijia (Scarlett) Qiao – Pharmacist and second year student
• Gurleen Mann – Third year student

Your participation is voluntary and you may withdraw from the study at any time. Your information is confidential.

You can also view and print our Participant Information Sheet as a PDF*.

*You will need the free Adobe Acrobat Reader to read and print this document.