Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes

Ligament Injury Clinical Trial

— OC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04899778
• Other study ID #: Pro00000922
• Status: Recruiting
• Phase: Phase 4
• Start date: September 29, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Cedars-Sinai Medical Center
• Contact: Natasha Trentacosta, MD
• Phone: 310-829-2663
• Email: natashatrentacosta[@]mac.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ligament Injury
• Wounds and Injuries

Intervention

Drug:
• Oral Contraceptive Pill, norethindrn a-e estradiol-iron
tablet

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ligamentous injury	ligament rupture or tear occurrence per athlete enrolled	over the course of 1 year
Secondary	Serum relaxin level	level of relaxin measured in each subject	baseline, 4 month visit
Secondary	Anterior Knee Laxity	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
Secondary	Hip rotation during a single-legged drop	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
Secondary	Knee rotation during a single-legged drop	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
Secondary	Joint Hypermobility	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 hyperlax. A score of zero indicates tight joints.	baseline, 4 month visit