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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Contraceptive Pill | Experimental | Oral contraceptive, 1/day, for one year |
|
| No Oral Contraceptive | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Contraceptive Pill, norethindrn a-e estradiol-iron | Drug | tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Injury | Any injury resulting in time away from practice or competition | over the course of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Relaxin Level | level of relaxin measured in each subject | baseline, 4 month visit |
| Anterior Knee Laxity | Anterior Knee laxity will be evaluated using the KT-2000 and measured in millimeters of anterior translation of the tibia relative to the femur |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Contraceptive Pill | Oral contraceptive, 1/day, for one year Oral Contraceptive Pill or IUC with hormones |
| FG001 | No Oral Contraceptive | No intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OCs Users | Participant athletes regularly took oral contraceptives or had a hormone-containing IUD. |
| BG001 | Non-OCs | Participant athletes were not on any form of contraception. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Injury | Any injury resulting in time away from practice or competition | collegiate and professional female athletes | Posted | Count of Participants | Participants | over the course of 1 year |
|
|
1 year
No adverse events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Contraceptive Pill | Oral contraceptive, 1/day, for one year Oral Contraceptive Pill, norethindrn a-e estradiol-iron: tablet |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melodie Metzger | Cedars-Sinai Medical Center | 310-423-7765 | Melodie.Metzger@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2025 | Apr 29, 2025 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D003276 | Contraceptives, Oral |
| D003267 | Contraception |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
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| baseline, 4 month visit |
| Hip Rotation During a Single-legged Drop | Hip flexion, adduction, and internal/external and coronal plane rotation of the knee measured during a singled-legged drop using motion tracking equipment. | baseline, 4 month visit |
| Knee Rotation During a Single-legged Drop | Hip flexion, adduction, and internal/external and coronal plane rotation of the knee measured during a singled-legged drop using motion tracking equipment. | baseline, 4 month visit |
| Joint Hypermobility | Beighton 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. | baseline, 4 month visit |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Serum Relaxin Level | level of relaxin measured in each subject | Not Posted | Feb 2025 | baseline, 4 month visit | Participants |
| Secondary | Anterior Knee Laxity | Anterior Knee laxity will be evaluated using the KT-2000 and measured in millimeters of anterior translation of the tibia relative to the femur | Not Posted | baseline, 4 month visit | Participants |
| Secondary | Hip Rotation During a Single-legged Drop | Hip flexion, adduction, and internal/external and coronal plane rotation of the knee measured during a singled-legged drop using motion tracking equipment. | Not Posted | baseline, 4 month visit | Participants |
| Secondary | Knee Rotation During a Single-legged Drop | Hip flexion, adduction, and internal/external and coronal plane rotation of the knee measured during a singled-legged drop using motion tracking equipment. | Not Posted | baseline, 4 month visit | Participants |
| Secondary | Joint Hypermobility | Beighton 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. | Not Posted | Apr 2025 | baseline, 4 month visit | Participants |
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | No Oral Contraceptive | No oral contraceptives used by athlete | 0 | 42 | 0 | 42 | 0 | 42 |
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| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |