Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes

Phase 4

Completed

• Conditions: Ligament Injury
• Interventions: Drug: Oral Contraceptive Pill, norethindrn a-e estradiol-iron

• Registration Number: NCT04899778
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-24
• Study Start: 2021-09-29
• Primary Completion: 2023-11-20
• Study Completion: 2024-06-30
• Results First Submitted: 2025-02-07
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Results First Posted: 2025-05-01
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Contraceptive Pill	Oral Contraceptive Pill, norethindrn a-e estradiol-iron	Oral contraceptive, 1/day, for one year

Primary Outcome Measures

Name	Time	Method
Injury	over the course of 1 year	Any injury resulting in time away from practice or competition

Secondary Outcome Measures

Name	Time	Method
Hip Rotation During a Single-legged Drop	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.
Knee Rotation During a Single-legged Drop	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.
Joint Hypermobility	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.
Serum Relaxin Level	baseline, 4 month visit	level of relaxin measured in each subject
Anterior Knee Laxity	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

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States