Ligament InjuryPhase 4OCNCT04899778
Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes
A Phase 4 study testing Oral Contraceptive Pill, norethindrn a-e estradiol-iron in people with Ligament Injury, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to examine the impact of one type of commonly used birth control pill on blood levels of relaxin and measure changes in knee movement to determine whether there are changes in joint instability (indicating the knee is less stable) that may predispose female athletes to injury. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ligament Injury
- What is being tested?
- Oral Contraceptive Pill, norethindrn a-e estradiol-iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2021to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- 18 years of age or older
- Currently playing basketball, soccer, or volleyball at Loyola Marymount or Pepperdine
- If not currently on COC, regular menstrual cycle occurring every 21-35 days
Who cannot join
- Previous ACL injury
- Underlying neuromuscular disease
- Medical contraindication to COC use
- History of pregnancy
- Desire to conceive in the next year
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Do Oral Contraceptives Protect Against Anterior Cruciate Ligament Injuries in Female Athletes
The purpose of this research study is to examine the impact of one type of commonly used birth control pill on blood levels of relaxin and measure changes in knee movement to determine whether there are changes in joint instability (indicating the knee is less stable) that may predispose female athletes to injury. Women not on hormonal birth control will also be enrolled to analyze differences between athletes on and not on birth control and to evaluate typical relaxin levels and knee laxity when birth control pills are not used.
- Conditions
- Ligament Injury
- Being tested
- Oral Contraceptive Pill, norethindrn a-e estradiol-iron
- Keywords
- anterior cruciate ligament, birth control, oral contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Contraceptive Pill, norethindrn a-e estradiol-ironDrug
Also called Birth Control, norethindrn a-e estradiol-iron, Blisovi 24 Fe 1 mg-20 mcg
tablet
| Study group | Role | What they receive |
|---|---|---|
| Oral Contraceptive Pill | Experimental | Oral contraceptive, 1/day, for one year Receives: Drug: Oral Contraceptive Pill, norethindrn a-e estradiol-iron |
| No Oral Contraceptive | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury
Any injury resulting in time away from practice or competition
Measured: over the course of 1 year
Secondary outcomes (5)
Serum Relaxin Level
level of relaxin measured in each subject
Measured: baseline
Anterior Knee Laxity
Anterior Knee laxity will be evaluated using the KT-2000 and measured in millimeters of anterior translation of the tibia relative to the femur
Measured: baseline
Hip Flexion at Initial Contact During a Single-legged Drop
Hip flexion measured during a singled-legged drop using motion tracking equipment.
Measured: baseline
Knee Adduction Rotation During a Single-legged Drop
inward rotation of the knee during max knee flexion measured during a singled-legged drop using motion tracking equipment.
Measured: baseline
Joint Hypermobility
Beighton score will be used to assess overall joint laxity. The Beighton score is on a nine-point scale that is based on 5 joint maneuvers. The maximum score is 9, which indicates increased laxity in the joints. A score of zero indicates inflexible joints.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start29 Sep 2021
- Primary completion20 Nov 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasha Trentacosta, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899778
- Sponsor's protocol ID
- Pro00000922
- Acronym
- OC
- Status last verified
- Aug 2026
- First submitted
- 17 May 2021
- Last updated
- 9 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Oral Contraceptives Protect Against Anterior Cruciate Ligament Injuries in Female Athletes
- ClinicalTrials.gov ID
- NCT04899778
- Acronym / sponsor ID
- OC / Pro00000922
- Conditions
- Ligament Injury
- Keywords
- anterior cruciate ligament, birth control, oral contraceptive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Posted 1 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to examine the impact of one type of commonly used birth control pill on blood levels of relaxin and measure changes in knee movement to determine whether there are changes in joint instability (indicating the knee is less stable) that may predispose female athletes to injury. Women not on hormonal birth control will also be enrolled to analyze differences between athletes on and not on birth control and to evaluate typical relaxin levels and knee laxity when birth control pills are not used.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Contraceptive Pill | Experimental | Drug: Oral Contraceptive Pill, norethindrn a-e estradiol-ironOral contraceptive, 1/day, for one year |
| No Oral Contraceptive | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- 18 years of age or older
- Currently playing basketball, soccer, or volleyball at Loyola Marymount or Pepperdine
- If not currently on COC, regular menstrual cycle occurring every 21-35 days
Key exclusion criteria (5 listed)
- Previous ACL injury
- Underlying neuromuscular disease
- Medical contraindication to COC use
- History of pregnancy
- Desire to conceive in the next year
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 |
|---|---|---|
| Oral Contraceptive Pill, norethindrn a-e estradiol-ironAlso: Birth Control, norethindrn a-e estradiol-iron, Blisovi 24 Fe 1 mg-20 mcgtablet | Drug | Oral Contraceptive Pill |
Primary outcome
Injury
Time frame: over the course of 1 year
Any injury resulting in time away from practice or competition
5 secondary outcomes
Serum Relaxin Level
Time frame: baseline
Anterior Knee Laxity
Time frame: baseline
Hip Flexion at Initial Contact During a Single-legged Drop
Time frame: baseline
Knee Adduction Rotation During a Single-legged Drop
Time frame: baseline
Joint Hypermobility
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Ligament Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
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 Phase 4 study testing Oral Contraceptive Pill, norethindrn a-e estradiol-iron in people with Ligament Injury, run by Cedars-Sinai Medical Center 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 4 inclusion and 5 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 9 Sep 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Injury (time frame: over the course of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.