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NCT Number: NCT05934708

Examining the Role of Female Endogenous Sex Hormones in Eccentric Exercise

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.

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Key information

Conditions

Inflammatory Response Behavior Motor Activity

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Exercise Research Center

Los Angeles, California, 90033, United States

Location status: Recruiting

Location contact

Bailey McLagan, MS

CONTACT

[email protected]

323-442-2180

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eccentric leg extension

Behavioral

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Todd Schroeder, PhD

CONTACT

[email protected]

3234422180

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2023
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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