Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes (OC)

April 29, 2025 updated by: Natasha Trentacosta, Cedars-Sinai Medical Center

Do Oral Contraceptives Protect Against Anterior Cruciate Ligament Injuries in Female Athletes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female
  • 18 years of age or older
  • Currently playing basketball, soccer, or volleyball at Loyola Marymount or Pepperdine
  • If not currently on COC, regular menstrual cycle occurring every 21-35 days

Exclusion Criteria:

  • Previous ACL injury
  • Underlying neuromuscular disease
  • Medical contraindication to COC use
  • History of pregnancy
  • Desire to conceive in the next year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Contraceptive Pill
Oral contraceptive, 1/day, for one year
Drug: Oral Contraceptive Pill, norethindrn a-e estradiol-iron
tablet
Other Names:
  • Birth Control, norethindrn a-e estradiol-iron
  • Blisovi 24 Fe 1 mg-20 mcg
No Intervention: No Oral Contraceptive
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injury
Time Frame: over the course of 1 year
Any injury resulting in time away from practice or competition
over the course of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior Knee Laxity
Time Frame: baseline, 4 month visit
Anterior Knee laxity will be evaluated using the KT-2000 and measured in millimeters of anterior translation of the tibia relative to the femur
baseline, 4 month visit
Serum Relaxin Level
Time Frame: baseline, 4 month visit
level of relaxin measured in each subject
baseline, 4 month visit
Hip Rotation During a Single-legged Drop
Time Frame: baseline, 4 month visit
Hip flexion, adduction, and internal/external and coronal plane rotation of the knee measured during a singled-legged drop using motion tracking equipment.
baseline, 4 month visit
Knee Rotation During a Single-legged Drop
Time Frame: baseline, 4 month visit
Hip flexion, adduction, and internal/external and coronal plane rotation of the knee measured during a singled-legged drop using motion tracking equipment.
baseline, 4 month visit
Joint Hypermobility
Time Frame: baseline, 4 month visit
Beighton score will be used to assess overall joint laxity. The Beighton score is on a nine-point scale that is based on 5 joint maneuvers. The maximum score is 9, which indicates increased laxity in the joints. A score of zero indicates inflexible joints.
baseline, 4 month visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2021

Primary Completion (Actual)

November 20, 2023

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00000922

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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