The Influence of Oral Contraceptives During Disuse

NCT06275048 | Completed

• 1 other identifier: STUDY00006302
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Contraceptives; Rehabilitation; Menstrual Cycle; Physical Therapy

Keywords

oral contraceptives; menstrual cycle; immobilization; weakness; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Grip Strength

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

  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.

Secondary Outcomes (1)

• Muscle activation

  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.

Study Arms (1)

Wrist/hand immobilization

EXPERIMENTAL

Participants will have their wrist and hand immobilized using a rigid splint continuously for 7 days. The splint will restrict all wrist and hand movement and must be worn at all times for the full 7 day period, and may only be removed under supervision of the research participants.

Other: Wrist/hand immobilization

Interventions

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.

Wrist/hand immobilization

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Biological males and females. Gender identity must be consistent with biological sex.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Asthenia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 23, 2024
• Study Start: January 26, 2024
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD will be made available beginning 1 year after the study completion date.
• Access Criteria: Researchers must submit a methodologically sound proposal outlining their planned analysis of the data. Proposals will be reviewed and approved by an independent panel appointed by the Principal Investigator. Requests should be sent to matt.stock@ucf.edu

Locations

US (1)