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Hormone Therapy

Oral Contraceptives for ACL Injuries (OC Trial)

Phase 4
Recruiting
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over the course of 1 year
Awards & highlights

OC Trial Summary

This trial studies how 1 type of birth control pill affects knee movement & joint instability in female athletes, & compares it to athletes not on birth control.

Who is the study for?
This trial is for female athletes over 18 who play basketball, soccer, or volleyball at Loyola Marymount or Pepperdine. Participants can be on birth control pills or not but should have regular menstrual cycles if they're not. They can't join if they've had an ACL injury before, neuromuscular disease, health reasons preventing birth control use, a history of pregnancy, or plans to conceive soon.Check my eligibility
What is being tested?
The study tests whether a common oral contraceptive pill affects the blood levels of relaxin and knee movement in female athletes. It aims to see if the pill changes joint stability and potentially lowers the risk of ACL injuries by comparing those using it with those who don't.See study design
What are the potential side effects?
While specific side effects are not listed for this trial, typical side effects from oral contraceptives may include nausea, weight gain, mood changes, menstrual spotting between periods and breast tenderness.

OC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am female.

OC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over the course of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and over the course of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ligamentous injury
Secondary outcome measures
Cutis Laxa
Hip rotation during a single-legged drop
Joints
+2 more

OC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Oral Contraceptive PillExperimental Treatment1 Intervention
Oral contraceptive, 1/day, for one year
Group II: No Oral ContraceptiveActive Control1 Intervention
No intervention

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
500 Previous Clinical Trials
164,763 Total Patients Enrolled
1 Trials studying Ligament Injury
45 Patients Enrolled for Ligament Injury

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes
Natasha Trentacosta 2021. "Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04899778.
All > Acl > Birth Control
~11 spots leftby Sep 2024
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