search
Back to results

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

Primary Purpose

Ligament Injury

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oral Contraceptive Pill, norethindrn a-e estradiol-iron
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ligament Injury focused on measuring anterior cruciate ligament, birth control, oral contraceptive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cedars Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oral Contraceptive Pill

No Oral Contraceptive

Arm Description

Oral contraceptive, 1/day, for one year

No intervention

Outcomes

Primary Outcome Measures

Ligamentous injury
ligament rupture or tear occurrence per athlete enrolled

Secondary Outcome Measures

Serum relaxin level
level of relaxin measured in each subject
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
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.
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.
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.

Full Information

First Posted
May 17, 2021
Last Updated
September 5, 2023
Sponsor
Cedars-Sinai Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04899778
Brief Title
Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes
Acronym
OC
Official Title
Do Oral Contraceptives Protect Against Anterior Cruciate Ligament Injuries in Female Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
September 15, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ligament Injury
Keywords
anterior cruciate ligament, birth control, oral contraceptive

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Contraceptive Pill
Arm Type
Experimental
Arm Description
Oral contraceptive, 1/day, for one year
Arm Title
No Oral Contraceptive
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Oral Contraceptive Pill, norethindrn a-e estradiol-iron
Other Intervention Name(s)
Birth Control, norethindrn a-e estradiol-iron, Blisovi 24 Fe 1 mg-20 mcg
Intervention Description
tablet
Primary Outcome Measure Information:
Title
Ligamentous injury
Description
ligament rupture or tear occurrence per athlete enrolled
Time Frame
over the course of 1 year
Secondary Outcome Measure Information:
Title
Serum relaxin level
Description
level of relaxin measured in each subject
Time Frame
baseline, 4 month visit
Title
Anterior Knee Laxity
Description
Anterior Knee laxity will be evaluated using the KT-2000 and measured in millimeters of anterior translation of the tibia relative to the femur
Time Frame
baseline, 4 month visit
Title
Hip rotation during a single-legged drop
Description
Hip flexion, adduction, and internal/external and coronal plane rotation of the knee measured during a singled-legged drop using motion tracking equipment.
Time Frame
baseline, 4 month visit
Title
Knee rotation during a single-legged drop
Description
Hip flexion, adduction, and internal/external and coronal plane rotation of the knee measured during a singled-legged drop using motion tracking equipment.
Time Frame
baseline, 4 month visit
Title
Joint Hypermobility
Description
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.
Time Frame
baseline, 4 month visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natasha Trentacosta, MD
Phone
310-829-2663
Email
natashatrentacosta@mac.com
First Name & Middle Initial & Last Name or Official Title & Degree
Melodie F Metzger, PhD
Phone
925-788-1519
Email
Melodie.Metzger@cshs.org
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Trentacosta, MD
Phone
310-829-2663
Email
natasha.trentacosta@cshs.org
First Name & Middle Initial & Last Name & Degree
Melodie Metzger, PhD
Phone
3104237765
Email
Melodie.Metzger@cshs.org

12. IPD Sharing Statement

Learn more about this trial

Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes

We'll reach out to this number within 24 hrs