Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes

NCT04899778 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00000922
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Ligament Injury

Keywords

anterior cruciate ligament; birth control; oral contraceptive

Outcome Measures

Primary Outcomes (1)

• Injury

  Any injury resulting in time away from practice or competition

  over the course of 1 year

Secondary Outcomes (5)

• Serum Relaxin Level

  baseline, 4 month visit

• Anterior Knee Laxity

  baseline, 4 month visit

• Hip Rotation During a Single-legged Drop

  baseline, 4 month visit

• Knee Rotation During a Single-legged Drop

  baseline, 4 month visit

• Joint Hypermobility

  baseline, 4 month visit

Study Arms (2)

Oral Contraceptive Pill

EXPERIMENTAL

Oral contraceptive, 1/day, for one year

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

No Oral Contraceptive

NO INTERVENTION

No intervention

Interventions

Oral Contraceptive Pill, norethindrn a-e estradiol-iron DRUG

tablet

Also known as: Birth Control, norethindrn a-e estradiol-iron, Blisovi 24 Fe 1 mg-20 mcg

Oral Contraceptive Pill

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

Contraceptives, Oral; Contraception

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Reproductive Techniques; Therapeutics

Results Point of Contact

• Title: Dr. Melodie Metzger
• Organization: Cedars-Sinai Medical Center

Melodie.Metzger@cshs.org

310-423-7765

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 24, 2021
• Study Start: September 29, 2021
• Primary Completion: November 20, 2023
• Study Completion: June 30, 2024
• Last Updated: May 1, 2025
• Results First Posted: May 1, 2025

Record last verified: 2025-04

Locations

US (1)