Oral ContraceptivesNCT06275048
The Influence of Oral Contraceptives During Disuse
A study testing Wrist/hand immobilization in people with Oral Contraceptives and Rehabilitation, run by University of Central Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Contraceptives, Rehabilitation, Menstrual Cycle
- What is being tested?
- Wrist/hand immobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2024to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: The Effects of Oral Contraceptive Use on Grip Strength and Neuromuscular Activation During Short-Term Immobilization of the Wrist/Hand
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
- Being tested
- Wrist/hand immobilization
- Keywords
- oral contraceptives, menstrual cycle, immobilization, weakness, rehabilitation
- Medical subject headings
- Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist/hand immobilizationOther
Study participants will have their left wrist/hand immobilized with a splint for 7 days. The splint will be worn 24 hours per day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Wrist/hand immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength
Maximal force (N) will be measured during a grip strength test
Measured: 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
Surface electromyographic amplitude of hand and wrist muscles will be measured during the maximal grip tests.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start26 Jan 2024
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral ContraceptivesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matt Stock, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275048
- Sponsor's protocol ID
- STUDY00006302
- Status last verified
- May 2025
- First submitted
- 9 Feb 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to make de-identified individual participant data (IPD) from this study available to other researchers once the primary analysis is completed and the study results have been published. The data will be shared in a manner that protects participant confidentiality and adheres to applicable laws and regulations.
Publications
Stock MS, Bauerlein HM, Edwards MF, Stambaugh KE, Parsowith EJ, Carr JC, Smith-Ryan AE, Richardson RM. Effects of Oral Contraceptives and Biological Sex on Grip Strength and Excitation during Immobilization and Recovery: An Exploratory Clinical Trial. Med Sci Sports Exerc. 2026 Apr 1;58(4):798-811. doi: 10.1249/MSS.0000000000003889. Epub 2025 Nov 4.
PubMed 41187315
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral Contraceptive Use on Grip Strength and Neuromuscular Activation During Short-Term Immobilization of the Wrist/Hand
- ClinicalTrials.gov ID
- NCT06275048
- Acronym / sponsor ID
- STUDY00006302
- Conditions
- Oral Contraceptives, Rehabilitation, Menstrual Cycle, Physical Therapy
- Keywords
- oral contraceptives, menstrual cycle, immobilization, weakness, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wrist/hand immobilization | Experimental | Other: Wrist/hand immobilizationParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist/hand immobilizationStudy participants will have their left wrist/hand immobilized with a splint for 7 days. The splint will be worn 24 hours per day. | Other | Wrist/hand immobilization |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Derived from this study: PubMed 41187315Stock MS, Bauerlein HM, Edwards MF, Stambaugh KE, Parsowith EJ, Carr JC, Smith-Ryan AE, Richardson RM. Effects of Oral Contraceptives and Biological Sex on Grip Strength and Excitation during Immobilization and Recovery: An Exploratory Clinical Trial. Med Sci Sports Exerc. 2026 Apr 1;58(4):798-811. doi: 10.1249/MSS.0000000000003889. Epub 2025 Nov 4.
- Individual participant dataSharing planned: Yes. We plan to make de-identified individual participant data (IPD) from this study available to other researchers once the primary analysis is completed and the study results have been published. The data will be shared in a manner that protects participant confidentiality and adheres to applicable laws and regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist/hand immobilization in people with Oral Contraceptives and Rehabilitation, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06275048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.