Oral Contraceptives for ACL Injuries

(OC Trial)

Overseen By Melodie F Metzger, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Previous ACL injury, Neuromuscular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the popular birth control pill norethindrone a-e estradiol-iron might impact knee stability in female athletes. Researchers examine blood levels of the hormone relaxin and its potential effect on knee movement, which could lead to injuries. The study includes athletes who take birth control and those who do not, to identify any differences in knee stability and hormone levels. Women who play basketball, soccer, or volleyball at Loyola Marymount or Pepperdine and have regular periods can participate, provided they have not had a previous ACL injury. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment benefits more patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It focuses on women who are either on birth control pills or not, so it might depend on your current medication. Please consult with the trial coordinators for more details.

What is the safety track record for norethindrn a-e estradiol-iron?

Research has shown that birth control pills are generally safe for use. The pill under study contains norethindrone acetate and ethinyl estradiol, ingredients often prescribed and well-tolerated by many women.

Some studies suggest that hormonal birth control might reduce the risk of serious knee injuries, such as ACL tears, in athletes. Although debate continues about the extent of protection they offer, millions have safely used these contraceptives.

Overall, these pills are considered safe and have a well-established safety record. Most users experience only mild side effects, if any. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using oral contraceptives, specifically norethindrone acetate with ethinyl estradiol and iron, for ACL injury treatment because it represents a novel approach that could potentially influence recovery. Unlike standard treatments for ACL injuries, which typically involve physical therapy or surgery, this oral contraceptive might affect the hormonal balance and inflammatory response, possibly aiding in tissue repair and reducing recovery time. This new angle could pave the way for less invasive treatment options, offering a complementary or alternative path to traditional physical rehabilitation and surgical methods.

What evidence suggests that this treatment might be an effective treatment for ACL injuries?

Research has shown that hormonal birth control may lower the risk of ACL injuries. A large study involving 5 million women found that combined hormonal contraceptives (CHC) might help prevent injuries like ACL tears. Another study suggested that birth control pills with more progestin than estrogen could reduce injury risk by lessening the effects of relaxin, a hormone that can loosen joints. In this trial, participants in the "Oral Contraceptive Pill" arm will take an oral contraceptive daily for one year to evaluate its potential in reducing joint instability and injury risk for female athletes. ^{1 2 4 6 7}

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

Currently playing basketball, soccer, or volleyball at Loyola Marymount or Pepperdine

I am female.

If not currently on COC, regular menstrual cycle occurring every 21-35 days

Exclusion Criteria

Desire to conceive in the next year

History of pregnancy

Previous ACL injury

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

1 year

Baseline, 4 month visit

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on knee laxity and injury occurrence.

4 months

What Are the Treatments Tested in This Trial?

Interventions

• norethindrn a-e estradiol-iron

Trial Overview 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.

How Is the Trial Designed?

Group I: Oral Contraceptive Pill Experimental Treatment 1 Intervention

Oral contraceptive, 1/day, for one year

Group II: No Oral Contraceptive Active Control 1 Intervention

No intervention

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39983800/

Use of Hormonal Contraceptives Is Associated With ... Systemic hormonal contraceptive use is associated with a lower incidence of ACL injury requiring ACL reconstruction compared with no contraceptive use in ...

2. bjsm.bmj.com bjsm.bmj.com/content/57/18/1195

a systematic review with data from 5 million females Some proponents of CHC suggest they may be protective against musculoskeletal injuries including anterior cruciate ligament tears. WHAT THIS STUDY ADDS. There ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31765227/

The Effect of Oral Contraceptive Hormones on Anterior ... OC formulations with high progestin-to-estrogen ratios may benefit female athletes by reducing their ACL injury risk by decreasing the effects of relaxin on ...

4. cdr.lib.unc.edu cdr.lib.unc.edu/downloads/1g05fn28j

effects of oral contraceptives on impact loading associated ... Sex hormones change the strain behavior and metabolism of the human ACL, and fluctuations in hormones levels can increase female's risk of suffering ACL injury.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04986267

The Effects of Hormonal Contraceptives on Incidence ... The aim of this study is to investigate how hormonal contraceptives affect ACL rupture incidence within menstrual cycle phases. It is thought hormones such ...

6. journals.psu.edu journals.psu.edu/medicine/article/view/62404/61830

View of Type of Oral Contraceptive Pills in Patients ... - Journals Oral contraceptive pills (OCPs) may reduce the risk of ACL injuries in females, but the effects of different types of OCPs have not been examined. This study ...

7. ors.org ors.org/transactions/2024/25.pdf

Incidence of ACL Injuries in Females by Selective Use of ... Incidence of ACL Injuries in Females by Selective Use of Oral Contraceptive Pills ... norethindrone (NE) only, drospirenone (DS) + ethinyl estradiol (EE) ...