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Menstrual Cycle PhaseMC-EIMDNCT07322874

Menstrual Cycle and Exercise-induced Muscle Damage

A study testing Exercise during follicular phase and Exercise during luteal phase in people with Menstrual Cycle Phase, run by Chariklia K. Deli at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to investigate the effect of the different menstrual cycle phases on the recovery from exercise-induced muscle injury in eumenorrheic women. For this purpose, in a cross-over, randomized study, at least 10 healthy eumenorrheic women aged 18-35 years will participate. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Menstrual Cycle Phase
What is being tested?
Exercise during follicular phase and Exercise during luteal phase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteGreece
Study dates
1 Mar 2025to 30 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Physically active subjects (VO2max ≥35ml/kg/min)
  • Absence of musculoskeletal injury (≥6 months)
  • Abstinence from the use of ergogenic supplements (≥1 month)
  • Abstinence from anti-inflammatory drugs (≥1 month)
  • Abstinence from participating in exercise with eccentric content for at least 7 days before exercise
  • Abstinence from alcohol and energy drinks before exercise

Who cannot join

  • Recent history of musculoskeletal injury (<6 months)
  • Use of ergogenic performance supplements (<1 month)
  • Taking anti-inflammatory drugs (<1 month)
  • Participation in exercise with eccentric content in the previous 7 days before exercise
  • Consumption of alcohol and energy drinks before exercise

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Department of Physical Education and Sport Science, University of Thessaly

    Trikala, Thessaly, 42100

Other trials in Greece

About this study

Official title: The Effect of Menstrual Cycle on Exercise-induced Muscle Damage

The aim of the study is to investigate the effect of the different menstrual cycle phases on the recovery from exercise-induced muscle injury in eumenorrheic women. For this purpose, in a cross-over, randomized study, at least 10 healthy eumenorrheic women aged 18-35 years will participate. In a random order, the participants will perform 45 min downhill (-15% slope) running on a treadmill at 70% HRmax followed by a maximal time-trial (95% HRmax) to exhaustion: i) during the follicular phase and ii) during the luteal phase. Before the exercise protocol, as well as at 24 h, 48 h and 72 h following exercise, complete blood count, delayed onset of muscle soreness (DOMS), creatine kinase activity, countermovement jump, isometric, concentric and eccentric strength of knee extensors and knee flexors, will be assessed. In addition, lactic acid concentration will be assessed before and immediately following exercise, and DOMS will be assessed immediately after the end of exercise. Following a washout period of ≥28 days (depending on the length of the menstrual cycle), participants will repeat the exact same procedure for the remaining phase of the menstrual cycle.

Read the detailed description

Research in the field of athletic training and rehabilitation, has traditionally focused on men, ignoring the physiological differences between sexes that may significantly affect athletic performance and recovery following exercise-induced muscle damage (EIMD). According to recent reviews of research in sports and exercise medicine, female representation is particularly limited, with only 4% - 13% of studies including women [1]. However, the number of females' participation in regular exercise and sports constantly increases, therefore it is imperative to define EIMD in women.

Except for being limited, most of the existing studies in women have been conducted during the early follicular phase of the cycle, when estrogen and progesterone levels are low, so that women's hormonal profile resembles that of men [2], in order to avoid any fluctuations [3]. However, this approach limits our understanding of the effects of the other phases of the cycle, such as the luteal phase, on performance and exercise-induced inflammation, and thus on women's ability to train and perform.

Although limited, some data suggest the influence of different phases of the menstrual cycle on both performance and exercise-induced muscle injury. For example, women's thermoregulatory levels are higher during the luteal phase of the cycle, which may affect their cardiovascular performance and endurance [4]. Similar data suggest that hormonal fluctuations may also affect recovery from EIMD [5]. Indicatively, the concentration of CK and IL-6 24 h and 72 h following 90 min of continuous running at 70% of VO2max was higher during the follicular phase [6].

Considering the above, research regarding the effect of the different phases of the menstrual cycle on performance and EIMD, it is crucial for the effective design of individualized training programs depending on the phase of the menstrual cycle, to improve performance and avoid injuries in women.

The aim of the study is to investigate the effect of the different menstrual cycle phases on the recovery from EIMD in eumenorrheic women.

According to an initial power analysis performed (probability error: 0.05, power: 0.80), a number of 8-10 individuals is required in order to identify statistically significant differences. Therefore, at least 10 participants will be included in the present study.

The design of the present study is cross-over, randomized and will be conducted in two cycles. The participants, after being informed about the study, as well as the benefits and potential risks, will sign an informed consent for participation in the study. Before the initiation of the data collection, familiarization of the participants with the assessment tests and the exercise protocol at low intensity, will precede. Also, the participants will provide a 7-days diet recall before their participation in the first experimental condition. Subsequently, baseline measurements will be performed at the Biochemistry, Physiology and Exercise Nutrition Laboratory (SmArT Lab), Department of Physical Education and Sports, University of Thessaly: anthropometric characteristics (body height, body mass, body mass index), body composition (body fat percentage, lean body mass, fat mass, bone density), aerobic capacity (VO2max). Subsequently, in a random order, the participants will perform 45 min of submaximal (at 70% HRmax) downhill (-15%) running on a treadmill followed by a maximal (95% HRmax) time-trial to exhaustion: i) during the follicular phase and ii) during the luteal phase. The randomization of the menstrual cycle phases will be done by a random integer sets generator, available online (Random.org). Before the exercise protocol, as well as 24 h, 48 h and 72 h following exercise, complete blood count (CBC), exercise-induced muscle injury [delayed onset muscle soreness (DOMS), creatine kinase (CK) activity] and muscle performance [(countermovement jump (CMJ), isometric, concentric and eccentric strength of knee extensors and knee flexors)] will be assessed. In addition, metabolism (lactic acid) will be assessed before and immediately following exercise, and DOMS will be assessed immediately after the end of exercise. Following a washout period of ≥28 days (depending on the length of the menstrual cycle), participants will repeat the exact same procedure for the remaining phase of the menstrual cycle.

Being tested
Exercise during follicular phase, Exercise during luteal phase
Keywords
menstrual cycle, follicular phase, luteal phase, exercise-induced muscle damage, muscle performance, muscle soreness
Medical subject headings
Myalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise during follicular phaseOther

    The participants will perform downhill running (-15% slope) on a treadmill at 70% of HRmax followed by running on a horizontal level (0% slope) at 95% HRmax until exhaustion, during the follicular phase

  • Exercise during luteal phaseOther

    The participants will perform downhill running (-15% slope) on a treadmill at 70% of HRmax followed by running on a horizontal level (0% slope) at 95% HRmax until exhaustion, during the luteal phase

Study groups in NCT07322874
Study groupRoleWhat they receive
Follicular phaseExperimentalThe participants will perform downhill running (-15% slope) on a treadmill at 70% of HRmax followed by running on a horizontal level (0% slope) at 95% HRmax until exhaustion, during the follicular phase
Receives: Other: Exercise during follicular phase
Luteal phaseExperimentalThe participants will perform downhill running (-15% slope) on a treadmill at 70% of HRmax followed by running on a horizontal level (0% slope) at 95% HRmax until exhaustion, during the luteal phase
Receives: Other: Exercise during luteal phase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Creatine kinase (CK) activity

    CK activity will be measured in plasma using a Clinical Chemistry Analyzer with commercially available kits.

    Measured: At baseline (pre), post-, 24 hours post-, 48 hours post-, 72 hours post-trial

  2. Changes in delayed onset of muscle soreness (DOMS)

    DOMS of knee extensors, knee flexors, gluteal and gastrocnemius muscles of both lower extremities will be measured during palpation of the muscle belly and the distal region after performing three repetitions of a full squat.

    Measured: At baseline (pre), post-, 24 hours post-, 48 hours post-, 72 hours post-tria

  3. Changes in blood lactate concentration

    Lactate concentration will be measured in capillary blood with a hand-portable analyzer

    Measured: At baseline (pre), 4 minutes post-exercise

  4. Changes in countermovement jump (CMJ) height

    CMJ height will be measured with an optical system. Participants will perform 3 maximal CMJ jumps and the best effort will be recorded

    Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise

  5. Changes in isokinetic strength of knee extensors (KE) and knee flexors (KF)

    Isometric, concentric and eccentric peak torque of the KE and KF of both limbs will be assessed on an isokinetic dynamometer

    Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise

  6. Changes in complete blood count (CBC)

    CBC (white blood cells, erythrocytes, platelets) will be measured in an hematological analyzer with commercially available reagents

    Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise

Secondary outcomes (7)
  1. Differences in Estradiol concentration between trials

    Estradiol concentration will be measured in an automated analyzer with commercially available kits

    Measured: At late-follicular and mid-luteal phase (according to each participant's menstrual cycle length), before exercise

  2. Differences in Progesterone concentration between trials

    Progesterone concentration will be measured in an automated analyzer with commercially available kits

    Measured: At late-follicular and mid-luteal phase (according to each participant's menstrual cycle length), before exercise

  3. Body weight

    Body weight will be measured on a beam balance with stadiometer

    Measured: At late-follicular and mid-luteal phase (according to each participant's menstrual cycle length), before exercise

  4. Body height

    Body height will be measured on a beam balance with stadiometer

    Measured: At late-follicular and mid-luteal phase (according to each participant's menstrual cycle length), before exercise

  5. Body mass index (BMI)

    BMI will be calculated from the ratio of body mass/ body height squared

    Measured: At late-follicular and mid-luteal phase (according to each participant's menstrual cycle length), before exercise

  6. Body fat

    Body fat will be measured via bioelectrical impedance

    Measured: At late-follicular and mid-luteal phase (according to each participant's menstrual cycle length), before exercise

  7. Dietary intake

    Dietary intake will be assessed using 7-day diet recalls

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start1 Mar 2025
  3. Primary completion30 Dec 2025
  4. Study completion30 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07322874
Sponsor's protocol ID
Menstrual Cycle - EIMD
Acronym
MC-EIMD
Status last verified
Feb 2026
First submitted
7 Dec 2025
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Roepstorff C, Steffensen CH, Madsen M, Stallknecht B, Kanstrup IL, Richter EA, Kiens B. Gender differences in substrate utilization during submaximal exercise in endurance-trained subjects. Am J Physiol Endocrinol Metab. 2002 Feb;282(2):E435-47. doi: 10.1152/ajpendo.00266.2001.

    PubMed 11788377
  • Romero-Parra N, Cupeiro R, Alfaro-Magallanes VM, Rael B, Rubio-Arias JA, Peinado AB, Benito PJ; IronFEMME Study Group. Exercise-Induced Muscle Damage During the Menstrual Cycle: A Systematic Review and Meta-Analysis. J Strength Cond Res. 2021 Feb 1;35(2):549-561. doi: 10.1519/JSC.0000000000003878.

    PubMed 33201156
  • Ruby BC, Coggan AR, Zderic TW. Gender differences in glucose kinetics and substrate oxidation during exercise near the lactate threshold. J Appl Physiol (1985). 2002 Mar;92(3):1125-32. doi: 10.1152/japplphysiol.00296.2001.

    PubMed 11842049
  • Oosthuyse T, Strauss JA, Hackney AC. Understanding the female athlete: molecular mechanisms underpinning menstrual phase differences in exercise metabolism. Eur J Appl Physiol. 2023 Mar;123(3):423-450. doi: 10.1007/s00421-022-05090-3. Epub 2022 Nov 19.

    PubMed 36402915
  • D'Eon TM, Sharoff C, Chipkin SR, Grow D, Ruby BC, Braun B. Regulation of exercise carbohydrate metabolism by estrogen and progesterone in women. Am J Physiol Endocrinol Metab. 2002 Nov;283(5):E1046-55. doi: 10.1152/ajpendo.00271.2002.

    PubMed 12376334
  • Ose BM, Eisenhauer J, Roepe I, Herda AA, Vopat BG, Vopat LM. Where Are All the Female Participants in Sports and Exercise Medicine Research? A Decade Later. Am J Sports Med. 2025 Jul;53(8):2022-2028. doi: 10.1177/03635465241278350. Epub 2025 Jan 9.

    PubMed 39780766

Questions about this trial

What is this clinical trial studying?

A study testing Exercise during follicular phase and Exercise during luteal phase in people with Menstrual Cycle Phase, run by Chariklia K. Deli at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Creatine kinase (CK) activity (time frame: At baseline (pre), post-, 24 hours post-, 48 hours post-, 72 hours post-trial). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07322874, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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