Not yet recruitingPHASE1INTERVENTIONAL

Progesterone and Muscle Protein Synthesis in Premenopausal Women (MP4-MPS)

This study is investigating whether the hormone progesterone, given as a pill, influences how muscles in healthy young women respond to exercise. Specifically, researchers want to know if progesterone helps muscles grow or repair themselves after exercising, compared to a placebo (a dummy pill). This research is important because it could help us understand more about women's muscle health. Participants will take either progesterone or a placebo, do an exercise session with one leg, and then have some blood tests and small muscle samples taken. This helps scientists see how their muscles are reacting and repairing themselves.

At a glance

Status

Not yet recruiting

Phase

PHASE1

Sponsor

McMaster University

Enrolment target

Start

15 Sep 2025

Estimated completion

15 Dec 2025

Healthy Volunteers Female Progesterone Premenopausal

What is this study about?

This research study, called MP4-MPS, is looking into how a hormone called progesterone might affect muscle growth and repair in healthy young women. Progesterone is a natural hormone in women's bodies, and scientists are trying to understand its full role, including how it interacts with exercise.

Specifically, the study wants to see if taking progesterone in capsule form changes how much muscle protein your body makes after you've exercised. Muscle protein synthesis is the process your body uses to build and repair muscle. They also want to compare if there's a difference in this process between a leg that has exercised and a leg that has rested, to see if progesterone plays a role.

Currently, we don't fully understand how hormones like progesterone directly affect muscle response to exercise in women. This study aims to fill that knowledge gap. By understanding this better, we could potentially learn more about optimising muscle health and recovery for women in the future, although this study is just a first step.

Key takeaways

Exploring if progesterone affects muscle growth in women.
Compares progesterone to a dummy pill (placebo).
Involves exercise, blood tests, and tiny muscle samples.
For healthy women aged 18-30 with regular periods.
Helps understand women's unique muscle health.

Who may be eligible?

This study is looking for healthy women aged between 18 and 30 years old who were assigned female at birth and identify as female. You should have a healthy body weight for your height and generally be in good health. It's important that you have regular monthly periods and are not currently using any hormonal birth control (like the pill, patch, or injection), and haven't used them for at least three months.

There are also some reasons why you wouldn't be able to join. For example, if you use tobacco or vaping products, or if you have certain medical conditions like heart problems, stomach issues that affect how you swallow, or a history of serious blood clots. You also can't be pregnant, planning to become pregnant, or suspected to be pregnant. Researchers will review your medical history carefully to make sure it's safe for you to take part.

If you're taking any specific medications that can affect your body's protein processes, or if you have certain metal implants in your body, you wouldn't be able to participate either. You also need to be able to read and understand English to give your written consent to join the study.

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 aged 18-30?
Do you have regular monthly periods and not use hormonal birth control?
Are you generally in good health?
Do you not use tobacco or vaping products?
Are you not pregnant or planning to be?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be asked to take two oral capsules, either containing progesterone or a dummy pill (placebo), at specific times before your main study visit. During that visit, you'll perform an exercise session in the lab, focusing on extending one leg with weights. You'll do several sets until your muscle feels tired.

Throughout the visit, a special liquid will be given to you through an IV drip in your arm. This liquid helps researchers track muscle protein activity. You will also have several blood samples taken. Additionally, small samples of your muscle tissue will be collected from both your exercised leg and your rested leg using a simple procedure called a muscle biopsy. This study involves a single main visit for these procedures.

Potential risks and benefits

Participating in research studies like this can offer several potential benefits, such as contributing to scientific knowledge that may help other women in the future. While there's no direct personal medical benefit expected, some people find it rewarding to be part of advancing medical understanding. Potential risks include discomfort from the leg exercise, the IV insertion, and the muscle biopsies (which might cause some soreness or bruising). As with any medication, there's a chance of side effects from progesterone, although it will be closely monitored. You will be fully informed of all known risks before deciding to join, and you are free to withdraw from the study at any time without giving a reason, and it won't affect your medical care.

Locations (1)

Exercise Metabolism Research Laboratory
Verified postcode
Hamilton, Canada

Common questions

What is progesterone?

Progesterone is a natural hormone in women's bodies that plays a key role in the menstrual cycle and pregnancy, among other functions.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the study drug but contains no active medicine. It helps researchers compare the real effects of the drug.

What is a muscle biopsy?

A muscle biopsy is a procedure where a very small sample of muscle tissue is taken, usually with a needle. It might feel like a pinch or a brief sting, similar to getting a blood test.

Will I know if I'm taking progesterone or the placebo?

No, the study is 'double-blind,' meaning neither you nor the research team will know who is getting progesterone and who is getting the placebo until after the study is complete. This helps keep the results unbiased.

Will I be paid for taking part?

The study information does not specify payment, but you should always ask the research team about any compensation or reimbursement for travel expenses.

How to find out more

Stuart Phillips, Ph.D.

phillis@mcmaster.ca 905-525-9140 Official trial record

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