Oral Contraceptives for ACL Injuries
(OC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either an oral contraceptive pill daily for one year or no intervention to study the impact on knee stability and relaxin levels.
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on knee laxity and injury occurrence.
What Are the Treatments Tested in This Trial?
Interventions
- norethindrn a-e estradiol-iron
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor