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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
Must not have
Medical contraindication to COC use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over the course of 1 year
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal 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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am female.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot use combined oral contraceptives due to health reasons.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over the course of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over the course of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ligamentous injury
Secondary study objectives
Cutis Laxa
Hip rotation during a single-legged drop
Joints
+2 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
513 Previous Clinical Trials
163,289 Total Patients Enrolled
1 Trials studying Ligament Injury
45 Patients Enrolled for Ligament Injury