Recruiting

Hormonal InfluenceExamining the Role of Female Endogenous Sex Hormones in Eccentric Exercise

Sponsor:

University of Southern California

Code:

NCT05934708

Conditions

Inflammatory Response

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Eccentric leg extension

Study Details

Brief summary:

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.

Conditions

Inflammatory Response

Study ID

NCT05934708

Start date

Mar 7, 2025

Status verified date

Mar, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

May 30, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Low estrogen; low progesterone

Participants will come in while on their period. During this time estrogen and progesterone concentrations are low.

experimental: High estrogen; low progesterone

Participants will come in just before ovulation, when estrogen concentrations are high and progesterone concentrations remain low.

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.

Interventions

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.

Primary outcome measure

Preparedness to perform [ Time Frame: Pre exercise ]
Rating of difficulty [ Time Frame: 30 minutes ]
Inflammatory markers [ Time Frame: Change over time (pre/post, 24 hour, 48 hour) ]
Counter movement jump height [ Time Frame: 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) ]
Active Delayed Onset Muscle Soreness (DOMS) [ Time Frame: Change over time (pre/post, 24 hour, 48 hour) ]

Central Contacts and Locations

Central contacts

Todd Schroeder, PhD

3234422180 eschroed@pt.usc.edu

Locations

Clinical Exercise Research Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Bailey McLagan, MS

323-442-2180 mclagan@usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

menstrual cycle
exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-03-25.