Status:
NOT_YET_RECRUITING
Progesterone and Muscle Protein Synthesis in Premenopausal Women (MP4-MPS)
Lead Sponsor:
McMaster University
Conditions:
Healthy Volunteers
Female
Eligibility:
FEMALE
18-30 years
Phase:
PHASE1
Brief 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. Th...
Detailed Description
This is a single-site, randomized, double-blind, placebo-controlled Phase 1 clinical trial designed to evaluate the effects of micronized progesterone on exercise-induced skeletal muscle protein synth...
Eligibility Criteria
Inclusion
- 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.
- Willing and able to provide written informed consent in English.
Exclusion
- 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.
- Current or recent use (within 3 months) of medications known to affect protein metabolism (e.g., glucocorticoids, systemic NSAIDs, isotretinoin, or anabolic agents).
- Personal or first-degree family history of thrombotic events (e.g., DVT, PE, stroke, myocardial infarction).
- Use of anticoagulant or antiplatelet medications.
- Excessive alcohol intake (\>21 units per week; 1 unit = 10 mL of pure ethanol).
- History of bleeding disorders or known coagulation or platelet abnormalities.
- Known hypersensitivity or allergy to micronized progesterone, soya, peanuts, or any excipients in the study capsule.
- History or current diagnosis of liver dysfunction or hepatic disease, unless liver function tests have returned to normal ranges.
- History or presence of contraindications to progesterone therapy, including any of the following:
- Known or suspected estrogen- or progestin-dependent malignancies (e.g., breast or endometrial cancer).
- History of endometrial hyperplasia or unexplained abnormal uterine bleeding.
- Active or prior history of arterial thromboembolic disease (e.g., stroke, myocardial infarction, coronary artery disease).
- History of classical migraine with aura.
- Active or prior history of venous thromboembolism (e.g., deep vein thrombosis, pulmonary embolism) or thrombophlebitis.
- History of partial or complete vision loss due to ophthalmic vascular events.
- Clinically significant anemia or hematologic abnormalities (e.g., low hemoglobin or hematocrit) that may elevate the risk of biopsy complications.
- Participation in another interventional study involving investigational drugs or invasive procedures within the past 30 days.
- Documented history of severe vasovagal syncope or needle phobia that may interfere with study compliance or safety.
- Known allergy or intolerance to any ingredient in the BOOST® 2.24 nutritional drink (e.g., milk protein, soy, corn-derived ingredients, cocoa, or artificial flavorings).
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07173361
Start Date
September 15 2025
End Date
December 15 2025
Last Update
September 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Exercise Metabolism Research Laboratory
Hamilton, Ontario, Canada, L8S 4K1