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

NCT07173361 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-25

No results posted yet for this study

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

Conditions

  • Healthy Volunteers
  • Female
  • Progesterone
  • Premenopausal

Interventions

DRUG

Micronized progesterone (oral capsules)

Two doses of 400 mg total micronized progesterone, administered as 2 × 200 mg capsules \~34 hours and \~10 hours prior to infusion trial, taken with a standardized nutritional drink.

DRUG

placebo capsule

Matched oral placebo capsules administered on the same schedule (\~34 and \~10 hours prior to infusion trial) with a standardized nutritional drink.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2025-12-15
Completion
2025-12-15

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07173361 on ClinicalTrials.gov