Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes

NCT ID: NCT04899778

Last Updated: 2025-05-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-29

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ligament Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Oral Contraceptive Pill

Oral contraceptive, 1/day, for one year

Group Type EXPERIMENTAL

Oral Contraceptive Pill, norethindrn a-e estradiol-iron

Intervention Type DRUG

tablet

No Oral Contraceptive

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oral Contraceptive Pill, norethindrn a-e estradiol-iron

tablet

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Natasha Trentacosta

Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00000922

Identifier Type: -

Identifier Source: org_study_id

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