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Completed

NCT Number: NCT04899778

Do Oral Contraceptives Protect Against ACL 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.

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Key information

Conditions

Ligament Injury

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Contraceptive Pill, norethindrn a-e estradiol-iron

Drug

tablet

Other names: Birth Control, norethindrn a-e estradiol-iron, Blisovi 24 Fe 1 mg-20 mcg

Primary outcomes

  1. Injury

    Time frame: over the course of 1 year

    Any injury resulting in time away from practice or competition

Secondary outcomes

  1. Serum Relaxin Level

    Time frame: baseline, 4 month visit

    level of relaxin measured in each subject

  2. 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

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Acronym: OC

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
May 24, 2021
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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