The Influence of Oral Contraceptives During Disuse

Completed · Not applicable

Conditions studied: Oral Contraceptives, Rehabilitation, Menstrual Cycle, Physical Therapy

In brief

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.

Key facts

Study ID

NCT06275048

Run by

University of Central Florida

People needed

41

Starts

2024-01-26

Expected to finish

2025-03-25

Last updated by the study team

2025-05-22

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University of Central Florida — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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