Trial Outcomes & Findings for Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes (NCT NCT04899778)
NCT ID: NCT04899778
Last Updated: 2025-05-01
Results Overview
Any injury resulting in time away from practice or competition
COMPLETED
PHASE4
73 participants
over the course of 1 year
2025-05-01
Participant Flow
Participant milestones
| Measure |
Oral Contraceptive Pill
Oral contraceptive, 1/day, for one year
Oral Contraceptive Pill or IUC with hormones
|
No Oral Contraceptive
No intervention
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
42
|
|
Overall Study
COMPLETED
|
31
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
OCs Users
n=31 Participants
Participant athletes regularly took oral contraceptives or had a hormone-containing IUD.
|
Non-OCs
n=42 Participants
Participant athletes were not on any form of contraception.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=31 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=73 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=31 Participants
|
40 Participants
n=42 Participants
|
70 Participants
n=73 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=31 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=73 Participants
|
|
Age, Continuous
|
21.3 years
STANDARD_DEVIATION 3.3 • n=31 Participants
|
21.9 years
STANDARD_DEVIATION 3.7 • n=42 Participants
|
21.6 years
STANDARD_DEVIATION 3.5 • n=73 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=31 Participants
|
42 Participants
n=42 Participants
|
73 Participants
n=73 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=31 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=73 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: over the course of 1 yearPopulation: collegiate and professional female athletes
Any injury resulting in time away from practice or competition
Outcome measures
| Measure |
Oral Contraceptive Pill
n=31 Participants
Oral contraceptive, 1/day, for one year
Oral Contraceptive Pill or IUC with hormones
|
No Oral Contraceptive
n=42 Participants
No intervention
|
|---|---|---|
|
Injury
|
8 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: baseline, 4 month visitlevel of relaxin measured in each subject
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 4 month visitAnterior Knee laxity will be evaluated using the KT-2000 and measured in millimeters of anterior translation of the tibia relative to the femur
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 4 month visitHip flexion, adduction, and internal/external and coronal plane rotation of the knee measured during a singled-legged drop using motion tracking equipment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 4 month visitHip flexion, adduction, and internal/external and coronal plane rotation of the knee measured during a singled-legged drop using motion tracking equipment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 4 month visitBeighton 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 increased laxity in the joints. A score of zero indicates inflexible joints.
Outcome measures
Outcome data not reported
Adverse Events
Oral Contraceptive Pill
No Oral Contraceptive
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place