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Completed

NCT Number: NCT06275048

The Influence of Oral Contraceptives During Disuse

Studies across various sports and physical activities have consistently shown that females incur more injuries compared to their male counterparts, but the underlying reasons for this disparity remain poorly understood. While differences in hormone levels between males and females have been speculated to play a role, very little rigorous research has been conducted to directly examine potential connections between sex hormones and injury risk. Specifically, females have been shown to be at greater risk for hand and wrist injuries. The higher injury incidence begins at puberty and persists across the lifespan, suggesting a link to hormonal factors. However, significant gaps remain in understanding the relationships between the menstrual cycle, exogenous hormones from birth control, and risk factors for sports-related injury in females. The purpose of this study is to examine changes in muscle strength and neuromuscular activation among females using monophasic oral contraceptives, females not using oral contraceptives, and males during one week of wrist/hand immobilization.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Florida

Orlando, Florida, 32816, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Right handed males and females
  • Ages 18-35 years
  • For females, consistent use of monophasic oral contraceptives for the previous 6 months OR having completely refrained from contraceptives for the previous 6 months.

Exclusion criteria

  • Gender identity inconsistent with biological sex (due to the influence that drugs used for gender reassignment may have)
  • Females that are amenorrheic (lack of menstruation for ≥3 consecutive cycles) or oligomenorrheic (menstrual cycle length ≤36 days)
  • Menstrual cycle irregularities among females not using oral contraceptives (regularity defined as every 21 to 35 days and/or at least 5 periods in the last six months)
  • Any contraceptive use other than monophasic oral contraceptives within the last 6 months
  • Monophasic oral contraceptives that has been inconsistent over the previous 6 months
  • Score of greater than 2/5 on question 9, or a score of greater than 1/5 on question 10 or 11 on the quick Disabilities of the Arm, Shoulder and Hand outcome measure indicating pain/discomfort of the upper extremities (shoulder, elbow, wrist, hand)
  • Dominant hand is the left hand
  • Body Mass Index less than 18.5 kg/m2 or greater than 29.9 kg/m2
  • Current depression or anxiety
  • History of musculoskeletal injury, pain, or surgery of the elbow, wrist, or hand
  • Unwillingness to avoid upper-body exercise during Phase 1
  • Unwillingness to avoid exercise and alcohol 24 hours prior to each testing visit.
  • Neuromuscular disease (e.g., Multiple Sclerosis, amyotrophic lateral sclerosis, Parkinson's)
  • Metabolic disease (e.g., diabetes, thyroid disorder, metabolic syndrome)
  • Personal or family history of blood clots
  • Trouble using or controlling muscles
  • History of cancer
  • History of stroke
  • History of heart attack
  • History of arthritis
  • Allergy to rubbing alcohol
  • Lack of transportation to and from the laboratory
  • Current or planned pregnancy (within the next three months)
  • Implant of any kind
  • The use of medications that may increase the risk of blood clots (i.e., corticosteroids such as prednisone, testosterone and anabolic steroids, selective estrogen receptor modulators like tamoxifen, aromatase inhibitors including anastrozole, thalidomide and lenalidomide, erythropoiesis-stimulating agents such as epoetin alfa, antipsychotics like chlorpromazine, antidepressants including paroxetine, various cancer chemotherapies, immune modulating drugs, antivirals such as ritonavir, and tamoxifen).
  • The use of creatine monohydrate and beta alanine supplementation within the previous 6 months.
  • The use of any medication or supplement that could influence hormone levels within the previous 6 months.

Treatment and study plan

Wrist/hand immobilization

Other

Study participants will have their left wrist/hand immobilized with a splint for 7 days. The splint will be worn 24 hours per day.

Primary outcomes

  1. Grip Strength

    Time frame: Grip strength will be tested weekly for at least 3 weeks (i.e., baseline, post-immobilization, post 1 week recovery). Testing will continue every week following immobilization until grip strength has returned to baseline levels.

    Maximal force (N) will be measured during a grip strength test

Secondary outcomes

  1. Muscle activation

    Time frame: Grip strength will be tested weekly for at least 3 weeks (i.e., baseline, post-immobilization, post 1 week recovery). Testing will continue every week following immobilization until grip strength has returned to baseline levels.

    Surface electromyographic amplitude of hand and wrist muscles will be measured during the maximal grip tests.

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Registry information

Official study title

The Effects of Oral Contraceptive Use on Grip Strength and Neuromuscular Activation During Short-Term Immobilization of the Wrist/Hand

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2024
Registry last updated
May 22, 2025

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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