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

Cedars-Sinai Medical Center

Status and phase: Completed; Phase 4

Conditions: Ligament Injury

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04899778

Pro00000922

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Oral Contraceptive Pill

Experimental group

Description:

Oral contraceptive, 1/day, for one year

Treatment:

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

No Oral Contraceptive

No Intervention group

Description:

No intervention