Progesterone and Muscle Protein Synthesis in Premenopausal Women (MP4-MPS) (NCT07173361) | Clinical Trial Compass
CompletedPhase 1
Progesterone and Muscle Protein Synthesis in Premenopausal Women (MP4-MPS)
Canada20 participantsStarted 2026-01-01
Plain-language summary
The goal of this clinical trial is to learn if micronized progesterone (PROMETRIUM®) influences the muscle-building response to resistance exercise in healthy premenopausal women aged 18-30 years.
The main questions it aims to answer are:
1. Does progesterone change the rate of muscle protein synthesis after exercise?
2. Does progesterone alter the difference in synthesis between an exercised leg and a rested leg?
Researchers will compare micronized progesterone to a placebo to see if progesterone changes the way skeletal muscle adapts to resistance exercise.
Participants will:
* Take two oral doses of progesterone (400 mg total, 34 and 10 hours before testing) or placebo
* Complete a unilateral leg extension exercise session in the lab
* Receive an infusion of a stable isotope tracer and provide blood samples
* Undergo muscle biopsies from the exercised and rested legs
Who can participate
Age range
18 Years – 30 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Self-identifies as female and is assigned female at birth.
. Aged 18 to 30 years (inclusive).
. Body mass index (BMI) between 18 and 34.9 kg/m² (inclusive).
. In general, good health, as determined by a study-specific health screening questionnaire and medical history review.
. Reports regular menstrual cycles (21-35 days in length) for the past 3 consecutive months.
. Not currently using hormonal contraceptives and has completed a minimum 3-month washout period.
. Resting blood pressure \<140/90 mmHg at screening and on the infusion day.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Myofibrillar muscle protein synthesis (MPS) rate
Timeframe: 5 hours after standardized feeding and unilateral resistance exercise (infusion period)
. Willing and able to provide written informed consent in English.
Exclusion criteria
. Current use of tobacco, vaping products, or nicotine-containing substances.
. Ineligible for physical activity as determined by the Get Active Questionnaire (GAQ).
. Any medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, could interfere with the participant's ability to comply with study procedures or pose additional risk.
. Current gastrointestinal or swallowing disorders that may interfere with supplement ingestion (e.g., chronic diarrhea, regurgitation, dysphagia).
. Currently pregnant, planning to become pregnant, or known/suspected to be pregnant.
. Use of hormonal contraceptives within the past 3 months.
. Presence of any electronic medical devices or metallic implants that may interfere with DXA scanning or muscle biopsy procedures.
. History of neuromuscular disorders or muscle/bone wasting diseases.