Phase 4
N=73
Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes
Ligament Injury
Bottom Line
View on ClinicalTrials.gov: NCT04899778 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Injury — 8; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oral Contraceptive Pill, norethindrn a-e estradiol-iron (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Injury |
8; 16 | — |
| SECONDARY Serum Relaxin Level |
— | — |
| SECONDARY Anterior Knee Laxity |
— | — |
| SECONDARY Hip Rotation During a Single-legged Drop |
— | — |
| SECONDARY Knee Rotation During a Single-legged Drop |
— | — |
| SECONDARY Joint Hypermobility |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04899778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.