Oral Contraceptives for ACL Injuries
(OC Trial)
NT
MF
Overseen ByMelodie F Metzger, PhD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: Cedars-Sinai Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
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.
Eligibility Criteria
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
I am 18 years old or older.
Currently playing basketball, soccer, or volleyball at Loyola Marymount or Pepperdine
I am female.
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Exclusion Criteria
Desire to conceive in the next year
History of pregnancy
Previous ACL injury
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Treatment Details
Interventions
- norethindrn a-e estradiol-iron
Trial OverviewThe 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.
Participant Groups
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
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Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor
Trials
523
Recruited
165,000+
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