Examining the Role of Female Endogenous Sex Hormones in Eccentric Exercise

March 24, 2026 updated by: Todd Schroeder, University of Southern California
The fluctuating concentrations of female sex hormones, namely estrogen and progesterone may have an effect on the ability of the tissue to withstand challenging exercise conditions, such as eccentric exercise. These sex hormones have also been purported to influence the perceived difficulty of exercise. This study aims to uncover how the different estrogen and progesterone concentrations present throughout the menstrual cycle effect perceived readiness to perform, perceptions of difficulty, and different recovery metrics.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Although nearly half of the population is female, less than 10% of research resources are allocated to understanding how their dynamic physiology impacts athletic readiness, performance, and recovery. The fluctuating concentrations of female sex hormones, namely estrogen and progesterone may have an effect on the ability of the tissue to withstand challenging exercise conditions, such as eccentric exercise. This study aims to uncover how the different estrogen and progesterone concentrations present throughout the menstrual cycle effect perceived readiness to perform, perceptions of difficulty, and the inflammatory environment and quantification of muscle damage.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Clinical Exercise Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-35 years of age
  • BMI of 18.5-29.9 as a BMI below or above these cut points results in highly varied menstrual cycle lengths [15]
  • Not taking contraception or other types of medication that could influence reproductive status
  • Regular menstruation
  • Non-pregnant
  • Medically free from chronic diseases
  • Novel to downhill running
  • Weight greater than or equal to 110 lbs
  • Not taking exogenous hormones
  • Not suffering from known gynecological disease (i.e., PCOS, endometriosis, etc.) that may influence menstrual cycle regularity

Exclusion Criteria:

  • Amenorrhea or oligomenorrhea
  • Perimenopausal or menopausal
  • Recreational or professional trail or downhill runner
  • On a form of contraception
  • Cardiac disability
  • Pacemaker
  • Arterial disease
  • Uncontrolled hemorrhage
  • Blood clots
  • Pregnant or trying to become pregnant
  • Cancerous lesions
  • Sensory or mental impairment
  • Unstable fractures
  • Weight less than 110 lbs
  • Suffering from gynecological disease (i.e., PCOS, endometriosis, etc.) that may influence menstrual cycle regularity
  • Taking exogenous hormones

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low estrogen; low progesterone
Participants will come in while on their period. During this time estrogen and progesterone concentrations are low.
Behavioral: Eccentric leg extension
Participants will complete a 10 x 10 eccentric leg extension on a Cybex Norm dynamometer. Upon arrival, participants will be asked their perceived readiness to perform on a 11 point numeric rating scale. Before the running protocol a baseline blood sample will be collected, as well as passive and active delayed onset muscle soreness (DOMS), a countermovement jump. Half way through each set (i.e., after the 5th repetition) participants will be asked to rank their level of difficulty on a 11 point OMNI Res scale. This will occur during each set. Participants will have follow up blood draws, measures of muscle function (i.e, jump height) and soreness measured immediately after and 24 and 48 hours post-exercise.
Experimental: High estrogen; low progesterone
Participants will come in just before ovulation, when estrogen concentrations are high and progesterone concentrations remain low.
Behavioral: Eccentric leg extension
Participants will complete a 10 x 10 eccentric leg extension on a Cybex Norm dynamometer. Upon arrival, participants will be asked their perceived readiness to perform on a 11 point numeric rating scale. Before the running protocol a baseline blood sample will be collected, as well as passive and active delayed onset muscle soreness (DOMS), a countermovement jump. Half way through each set (i.e., after the 5th repetition) participants will be asked to rank their level of difficulty on a 11 point OMNI Res scale. This will occur during each set. Participants will have follow up blood draws, measures of muscle function (i.e, jump height) and soreness measured immediately after and 24 and 48 hours post-exercise.
Experimental: Medium estrogen; high progesterone
Participants will come in just after ovulation when estrogen concentrations are at a medium level, and progesterone concentrations are high.
Behavioral: Eccentric leg extension
Participants will complete a 10 x 10 eccentric leg extension on a Cybex Norm dynamometer. Upon arrival, participants will be asked their perceived readiness to perform on a 11 point numeric rating scale. Before the running protocol a baseline blood sample will be collected, as well as passive and active delayed onset muscle soreness (DOMS), a countermovement jump. Half way through each set (i.e., after the 5th repetition) participants will be asked to rank their level of difficulty on a 11 point OMNI Res scale. This will occur during each set. Participants will have follow up blood draws, measures of muscle function (i.e, jump height) and soreness measured immediately after and 24 and 48 hours post-exercise.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Counter movement jump height
Time Frame: Change over time (pre/post, 24 hour, 48 hour)
A countermovement jump (CMJ) will be performed on VALD ForceDecks to determine muscle function overtime.
Change over time (pre/post, 24 hour, 48 hour)
Passive Delayed Onset Muscle Soreness (DOMS)
Time Frame: Change over time (pre/post, 24 hour, 48 hour)
DOMS will be assessed as participants are stationary to assess their perception of muscle damage over time.
Change over time (pre/post, 24 hour, 48 hour)
Active Delayed Onset Muscle Soreness (DOMS)
Time Frame: Change over time (pre/post, 24 hour, 48 hour)
DOMS will be assessed as participants complete a wall sit to assess their perception of muscle soreness over time.
Change over time (pre/post, 24 hour, 48 hour)
Preparedness to perform
Time Frame: Pre exercise
Perceived readiness will be measured on an 11 point numeric rating scale (NRS) with 0 being not ready at all, and 10 being most prepared
Pre exercise
Rating of difficulty
Time Frame: 30 minutes
Perceived difficulty will be measured on a 11 point numeric rating scale called the OMNI res throughout the duration of exercise.
30 minutes
Inflammatory markers
Time Frame: Change over time (pre/post, 24 hour, 48 hour)
Inflammatory markers (IL-6, IL-8, TNF-alpha, and IL-10) will be measured in blood serum to understand how the concentration of estrogen changes the inflammatory response to damaging exercise.
Change over time (pre/post, 24 hour, 48 hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS-23-00363

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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