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Search / Trial NCT06214442

Effects of the Menstrual Cycle on Triceps Surae Properties in Women

Launched by MARCO AURÉLIO VAZ, PHD · Jan 9, 2024

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Mechanical Properties Material Properties Morphological Properites Estrogen Progesterone

ClinConnect Summary

This clinical trial is exploring how different phases of the menstrual cycle affect the properties of muscles and tendons, specifically focusing on the Achilles tendon and the triceps surae (the calf muscles) in women. Researchers want to understand if changes in hormone levels, particularly estrogen and progesterone, influence muscle stiffness, strength, and overall function. This information could help in planning better exercise and rehabilitation programs tailored for women.

To participate in the study, women aged 18 to 35 who have regular menstrual cycles or who use specific hormonal contraceptives may be eligible. Key requirements include having a healthy body weight, normal ankle function, and no history of lower limb injuries. Participants will undergo assessments during different phases of their menstrual cycle or while using hormonal contraception to see how their muscle and tendon properties change. It’s important to know that this study aims to improve our understanding of how hormonal changes can impact physical performance in women, which could lead to better health and fitness recommendations.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Inclusion criteria for the group of eumenorrheic women
  • Being eumenorrheic with a regular menstrual cycle lasting between 21 and 35 days during the last 6 months prior to study participation.
  • Body Mass Index between 20 and 25 kg/m2.
  • Normal ankle function and range of motion.
  • Do not use hormonal contraception of any kind or supplements hormones for at least the 6 months prior to the study.
  • No complaints of pain or history of lower limb injury.
  • In view of the COVID-19 pandemic, have completed vaccination will be used as an inclusion criteria.
  • For the physically active group, practice regular physical exercise at least 3 times a week for the past 6 months.
  • For the sedentary group, not practicing regular physical exercise in the last 6 months.
  • Inclusion criteria for the group users of hormonal oral contraception:
  • Body Mass Index between 20 and 25 kg/m2.
  • Normal ankle function and range of motion.
  • Make use of any method of oral hormonal contraception (compressed).
  • Make use of combined oral hormonal contraception with estrogen and progesterone (ethinylestradiol + Drospirenone) for at least 6 months before participating in the study.
  • Do not use other hormone supplements for at least 6 months prior to the study.
  • No complaints of pain or presence of pathologies in the lower limb
  • In view of the COVID-19 pandemic, have completed vaccination will be used as an inclusion criteria.
  • For the physically active group, practice regular physical exercise at least 3 times a week for the past 6 months.
  • For the sedentary group, not practicing regular physical exercise in the last 6 months
  • Exclusion Criteria:
  • Exclusion Criteria for eumenorrheic and contraception hormonal groups:
  • Health problems - contraindication to maximal effort exercise. Additionally, the following subjects will be excluded:
  • Women who have anovulatory cycles or phase lutea deficiency.
  • Women in early menopause.
  • Pregnant or lactating women.
  • Women with oligomenorrhea (menstrual cycles longer than 35 days, or delay of menstruation for the same period).
  • Women with hypothalamic amenorrhea.
  • Female smokers.
  • Women with metabolic syndrome.
  • For women using hormonal contraceptives, women who use adhesive, injectable, intrauterine devices, implants, vaginal rings, as well as progesterone-only CH methods.
  • Does not meet the inclusion criteria.

About Marco Aurélio Vaz, Phd

Dr. Marco Aurélio Vaz, PhD, is a distinguished clinical trial sponsor with extensive expertise in biomedical research and drug development. With a strong background in pharmacology and clinical methodologies, Dr. Vaz leads innovative studies aimed at advancing therapeutic options in various medical fields. His commitment to rigorous scientific standards and ethical practices ensures the integrity and reliability of clinical trial outcomes. Dr. Vaz collaborates with multidisciplinary teams to foster a culture of excellence, driving research initiatives that contribute to improved patient care and health outcomes.

Locations

Porto Alegre, , Brazil

Patients applied

0 patients applied

Trial Officials

Marco Vaz

Study Chair

Federal University of Rio Grande do Sul

Marco Vaz

Study Director

Federal University of Rio Grande do Sul

Marco Vaz

Principal Investigator

Federal University of Rio Grande do Sul

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported