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RecruitingNCT05802277MECA_CYCLEUpdated Feb 28, 2024

Characterization of the Mechanical Properties of the Hamstring Muscle Group in Female.

An interventional study of Hamstring muscles function assessment in Menstrual Cycle and Oral Contraceptive Use, sponsored by EZUS-LYON 1. Recruiting at 1 site in France. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by EZUS-LYON 1 · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled Oct 2022, registered Mar 2023).
  • Started Oct 2022; still recruiting 4 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

The goal of this clinical trial is to precise the impact of menstrual cycle and physical activity on the hamstrings muscle function in healthy active women. The main question it aims to answer is : is there a moment of the menstrual cycle when the muscle is better able to recover from a strenuous exercise ? Three appointments will be conducted to evaluate the hamstring muscles at difference moments of the menstrual cycle. Echographic and maximal force production measures will be done.

Researchers will compare these results with a group taking oral contraceptives.

02

Conditions studied

  • Menstrual Cycle
  • Oral Contraceptive Use

Keywords

  • Menstrual cycle
  • Oral contraception
  • Muscle mechanical properties
  • shear wave elastography
  • Hamstrings
03

In context

Lead sponsor

EZUS-LYON 1 is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subject aged between 18 and 35 years.
  • Subjects who practice at least 2 hours of sport per week with a competitive aim.
  • Subject who has not presented any musculo-tendinous pathology to the hamstrings in the last 6 months.
  • Subject with no musculoarticular pathology having a prolonged (more than 2 weeks) interruption of sports activities in the last 2 years.
  • Subject with no muscular pain or pathology currently.
  • Subject with no known cardiac disorders or family history that could present a risk known family history that could present a risk in case of intense physical effort.

physical exertion.

  • Subjects not taking any medication, which in the opinion of the that, in the opinion of the coordinating investigator, may interfere with the evaluation of the study criteria.
  • Subject able and willing to comply with the protocol and agreeing to give written informed consent.
  • Subject affiliated or benefiting from a Social Security plan.

Menstrual cycle group:

  • Subject whose last 3 menstrual cycles are of a regular duration (± 4 days maximum difference between 2 consecutive menstrual cycles).
  • Subject whose last 3 menstrual cycles are of a duration between 24 and 32 days (including milestones).
  • Absence of any contraceptive method likely to modulate the hormonal variations linked to the menstrual cycle.

hormonal variations related to the menstrual cycle, during the duration of the duration of the protocol and during the last 6 months after the participant's inclusion.

the participant. Mechanical contraception such as the diaphragm is permitted.

Oral contraceptive group:

  • Taking oral contraception, 2nd generation monophasic pill estrogen-progestin pill (Optilova®, Optidril®, Leeloo®, Minidril®, Ludeal®, Zikiale®, Lovavulo®, Lovapharm®) for at least 6 months.

Exclusion criteria

Exclusion Criteria:

  • Subjects with a medical contraindication to intense physical activity.
  • Subject with a positive pregnancy test result.
  • Subject with a medical or surgical history deemed by the coordinating investigator as being incompatible with the study.
  • Subjects under guardianship.
  • Subjects in a period of exclusion from another study.
  • Decision of the volunteer, whatever the reason.
  • Adverse event or effect affecting the safety of the volunteer in the opinion of the coordinating investigator.
  • Major deviation from the protocol.
  • Illness or injury interfering with the normal course of the protocol.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Menstrual cycle group

    Women who are not currently taking any form of hormonal contraception and who present a regular menstrual cycle.

    Diagnostic Test: Hamstring muscles function assessment

  • Active comparator
    Oral contraceptive group

    Women taking a second-generation oral contraceptive estrogen-progestogen pill.

    Diagnostic Test: Hamstring muscles function assessment

Interventions

  • Diagnostic testHamstring muscles function assessment

    Ultrasound echographic evaluation of the hamstring muscles during stretching and voluntary contractions, before and after a strenuous physical activity.

06

What researchers measure

Primary outcomes

  1. Hamstring muscles shear wave speed

    Differences according to menstrual cycle phase in hamstring muscles shear wave speed, as measured by ultrasound elastography

    Time frame: Length of a menstrual cycle (around on 28 day average)

Secondary outcomes

  1. Maximal voluntary force production

    Differences according to menstrual cycle phase in maximal voluntary isometric hamstrings force production, as measured by an isokinetic dynamometer

    Time frame: Length of a menstrual cycle (around on 28 day average)

  2. Hamstring muscles thickness

    Differences according to menstrual cycle phase in hamstring muscles thickness, as measured by ultrasound echography.

    Time frame: Length of a menstrual cycle (around on 28 day average)

  3. Hamstring muscles length of fascicles

    Differences according to menstrual cycle phase in hamstring muscles fascicles' length, as measured by ultrasound echography.

    Time frame: Length of a menstrual cycle (around on 28 day average)

  4. Hamstring muscles pennation angle

    Differences according to menstrual cycle phase in hamstring muscles pennation angle, as measured by ultrasound echography.

    Time frame: Length of a menstrual cycle (around on 28 day average)

  5. Hamstring muscles cross sectional area

    Differences according to menstrual cycle phase in hamstring muscles cross sectional area, as measured by ultrasound echography.

    Time frame: Length of a menstrual cycle (around on 28 day average)

  6. Hamstring tendons length

    Differences according to menstrual cycle phase in hamstring tendons length, as measured by ultrasound echography.

    Time frame: Length of a menstrual cycle (around on 28 day average)

  7. Maximal knee joint range of motion

    Measure of the volunteer maximal knee range of motion, the maximum being defined by the volunteer as the greatest hip/leg angle reachable without feeling pain. The process is slowly conducted on an isokinetic ergometer by extending the knee joint (2°/s) until the volunteer reaches her maximal range of motion, at which point the movement is stopped and a security is placed.

    Time frame: Length of a menstrual cycle (around on 28 day average)

07

Study locations

1 of 1 sites recruiting
  • Laboratoire Interuniversitaire de Biologie de la Motricité
    Villeurbanne, Rhône 69622, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05802277
Lead sponsor
EZUS-LYON 1
Collaborators
Laboratoire Interuniversitaire de Biologie de la Motricité
Responsible party
Sponsor
First posted
Apr 6, 2023
Start date
Oct 5, 2022
Primary completion
Apr 1, 2024 (estimated)
Completion
Apr 1, 2024 (estimated)
Last update
Feb 28, 2024

Study contacts

Melanie PRUDENT, MD
Contact
melanie.prudent@chu-lyon.fr
33472071862
Jeremie BOUVIER, MSc
Contact
jeremie.bouvier@univ-lyon1.fr
Alexandre Fouré, PhD
principal investigator · Université Claude Bernard Lyon 1
Cyril Martin, PhD
study director · Université Claude Bernard Lyon 1

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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