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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AR069176-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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The goal of this project is to test our central hypothesis that changes in sex hormone concentration result in changes to the basic elements of motor control - at multiple levels, from the musculotendinous unit to motor control circuitry. Under Aim 1 the investigator will determine the influence of sex hormone fluctuations on the muscle stretch reflex during active and passive states, and the time lag between hormone concentration changes and the reflex response. The investigator will use a technically simple assessment that could be implemented in the field. Under Aim 2 the investigator will determine the influence of sex hormone fluctuations on spinal motor neuron excitability using H-reflex as a probe and the simultaneous change in the muscle mechanics using muscle twitch response. Aims 1 & 2 will include a focus on the differential role of oral contraceptives. In Aim 3 the investigator will use paired-pulse transcranial magnetic stimulation during active contraction to determine the influence of sex hormone fluctuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Oral Contraceptive (NOC) | Females ages 18-39 years, who are eumenorrheic (regular monthly cycles of 24-35 days) and moderately active. Exclusion criteria: History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, history of disordered eating, of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease), history of or current diabetes, pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, medications that lower seizure threshold, and pregnancy. | ||
| Oral Contraceptive ( OC) | Females: ages 18-39 years, who are on a stable hormonal contraceptive regimen for 6 months (oral, transdermal or vaginal) and moderately active. Exclusion criteria: History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, history of disordered eating, of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease), history of or current diabetes, started or stopped taking oral contraceptives within the previous 6 months, participate in high impact endurance training (i.e. pre-marathon training, body building), or currently participating in competitive level sports. | ||
| Male | Males: Ages 18-39. Exclusion criteria: History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, history of disordered eating, of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease), history of or current diabetes, pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, and medications that lower seizure threshold. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Short-interval Intracortical Inhibition (SICI) During the Follicular Phase | The conditioned motor evoked potential (MEP) at each inter-stimulus interval (ISI) was normalized to MEP obtained from unconditioned stimulation. Change was evaluated by regressing the normalized conditioned motor evoked potential amplitude at each ISI with estradiol concentration. Average and standard deviation for each ISI reported. | day 1 menses up to day with highest estradiol concentration |
| Change in Stretch Reflex at Relaxed State | Muscle stretch reflex (MSR) was calculated by dividing the root mean squared (RMS) value of the electromyogram (EMG) response with the RMS of the muscle's EMG during maximal voluntary contraction and the force of the tapper used to elicit the reflex. Change was evaluated by regressing the ratio simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. Average and standard deviation for each menstrual phase is reported. | Follicular, Luteal |
| Change in Spinal Motor Neuron Excitability in Non Oral Contraceptive User | The spinal motor neuron excitability was measured by calculating the ratio between the maximum peak-to-peak value of H reflex and the maximum peak-to-peak value of M wave. Change was evaluated by regressing the ratio simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. Average and standard deviation for each menstrual phase is reported. | Follicular, Luteal |
| Normalized Conditioned Motor Evoked Potential in Male and Female | The conditioned motor evoked potential (MEP) at each inter-stimulus interval (ISI) was normalized to MEP obtained from unconditioned stimulation. The difference between male and female groups was evaluated using a 2 (male vs. female) x 7 (ISI) repeated measures ANOVA. Average and standard deviation for each ISI reported. | menses period for female, day 1 for male |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Steadiness of Isometric Force Production at 20% of Maximum Voluntary Contraction in Non Oral Contraceptive User | Steadiness of the exerted force is quantified using coefficient of variation. Change was evaluated by regressing the steadiness simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) follicular phase, and (2) luteal phase. Average and standard deviation for each phase is reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Muscle Twitch Peak Torque in Non Oral Contraceptive User | Change was evaluated by regressing the peak torque simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) follicular phase, and (2) luteal phase. Average and standard deviation for each phase is reported. | Follicular, Luteal |
Inclusion Criteria:
Exclusion Criteria:
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Non oral contraceptive group (NOC): Healthy females at 18-39 years old, who are eumenorrheic (regular monthly cycles of 24-35 days) and moderately active;
Oral contraceptive group (OC): Healthy females at 18-39 years old, who are on a stable hormonal contraceptive regimen for 6 months (oral, transdermal or vaginal) and moderately active;
Male group: Healthy males at 18-39 years old.
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| Name | Affiliation | Role |
|---|---|---|
| Yasin Dhaher, Ph.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Oral Contraceptive (NOC) | Females: ages 18-39 years, who are eumenorrheic (regular monthly cycles of 24-35 days) and moderately active. Exclusion criteria: History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, history of disordered eating, of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease), history of or current diabetes, history of menstrual dysfunction (primary or secondary amenorrhea, oligomenorrhea, anovulatory cycles, polycystic ovarian disease), current pregnancy, started or stopped taking oral contraceptives within the previous 6 months, participate in high impact endurance training (i.e. pre-marathon training, body building), or currently participating in competitive level sports. Specific exclusion criteria for TMS: pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, medications that lower seizure threshold. |
| FG001 | Oral Contraceptive (OC) | Females: ages 18-39 years, who are on a stable hormonal contraceptive regimen for 6 months (oral, transdermal or vaginal) and moderately active. Exclusion criteria: History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, history of disordered eating, of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease), history of or current diabetes, started or stopped taking oral contraceptives within the previous 6 months, participate in high impact endurance training (i.e. pre-marathon training, body building), or currently participating in competitive level sports. |
| FG002 | Male | Ages 18-39. Exclusion criteria: History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, history of disordered eating, of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease), history of or current diabetes, pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, medications that lower seizure threshold. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Oral Contraceptive (NOC) | Females: ages 18-39 years, who are eumenorrheic (regular monthly cycles of 24-35 days) and moderately active. Exclusion criteria: History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, history of disordered eating, of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease), history of or current diabetes, history of menstrual dysfunction (primary or secondary amenorrhea, oligomenorrhea, anovulatory cycles, polycystic ovarian disease), current pregnancy, started or stopped taking oral contraceptives within the previous 6 months, participate in high impact endurance training, or currently participating in competitive level sports. Specific exclusion criteria for TMS: pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, medications that lower seizure threshold, and pregnancy. |
| 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 | Changes in Short-interval Intracortical Inhibition (SICI) During the Follicular Phase | The conditioned motor evoked potential (MEP) at each inter-stimulus interval (ISI) was normalized to MEP obtained from unconditioned stimulation. Change was evaluated by regressing the normalized conditioned motor evoked potential amplitude at each ISI with estradiol concentration. Average and standard deviation for each ISI reported. | Participants in NOC group. | Posted | Mean | Standard Deviation | ratio to the unconditioned stimulus MEP | day 1 menses up to day with highest estradiol concentration |
|
Adverse event collection starts after the subject has provided informed consent, ends 30 days following the last research session, an average of 2 months for NOC group, 1 month for OC group, and 1 day for male group.
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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 | Non-Oral Contraceptive (NOC) | Females: ages 18-39 years, who are eumenorrheic (regular monthly cycles of 24-35 days) and moderately active. Exclusion criteria: History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, history of disordered eating, of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease), history of or current diabetes, history of menstrual dysfunction (primary or secondary amenorrhea, oligomenorrhea, anovulatory cycles, polycystic ovarian disease), current pregnancy, started or stopped taking oral contraceptives within the previous 6 months, participate in high impact endurance training, or currently participating in competitive level sports. Specific exclusion criteria for TMS: pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, medications that lower seizure threshold, and pregnancy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yasin Dhaher | UT southwestern medical center | 2146450064 | yasin.dhaher@utsouthwestern.edu |
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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 | May 8, 2020 | Apr 30, 2025 | Prot_SAP_000.pdf |
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Blood samples are collected every other day for a period of two months.
| Change in Spinal Motor Neuron Excitability in Oral Contraceptive User | The spinal motor neuron excitability was measured by calculating the ratio between the maximum peak-to-peak value of H reflex and the maximum peak-to-peak value of M wave. Change was evaluated by regressing the ratio simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. Average and standard deviation for active and inactive pill phase are reported. | Active pill, Inactive pill |
| Changes in Intracortical Facilitation (ICF) During the Follicular Phase | The conditioned motor evoked potential (MEP) at each inter-stimulus interval (ISI) was normalized to MEP obtained from unconditioned stimulation. Change was evaluated by regressing the normalized conditioned motor evoked potential amplitude at each ISI with estradiol concentration. Average and standard deviation for each ISI reported. | day 1 menses up to day with highest estradiol concentration |
| Change in Stretch Reflex at Active State | Muscle stretch reflex (MSR) was calculated by dividing the root mean squared (RMS) value of the electromyogram (EMG) response with the RMS of the muscle's EMG during maximal voluntary contraction and the force of the tapper used to elicit the reflex. Change was evaluated by regressing the ratio simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. Average and standard deviation for each menstrual phase is reported. | Follicular, Luteal |
| Follicular, Luteal |
| Change in Flexion Reflex Root Mean Squared Value in Non Oral Contraceptive User | The root mean squared (RMS) value were calculated and averaged for each testing visit. Change was evaluated by regressing the RMS simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) follicular phase, and (2) luteal phase. Average and standard deviation for each phase is reported. | Follicular, Luteal |
| Change in Flexion Reflex Duration in Non Oral Contraceptive User | The duration were calculated and averaged for each testing visit. Change was evaluated by regressing the duration simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) follicular phase, and (2) luteal phase. Average and standard deviation for each phase is reported. | Follicular, Luteal |
| Change in Flexion Reflex Latency in Non Oral Contraceptive User | The latency measured from the onset of the stimulus were calculated and averaged for each testing visit. Change was evaluated by regressing the latency simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) follicular phase, and (2) luteal phase. Average and standard deviation for each phase is reported. | Follicular, Luteal |
| Change in Flexion Reflex Root Mean Squared Value in Oral Contraceptive User | The root mean squared (RMS) value were calculated and averaged for each testing visit. Change was evaluated by regressing the RMS simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) active pill, and (2) inactive pill. Average and standard deviation for each phase is reported. | Active pill, Inactive pill |
| Change in Flexion Reflex Duration in Oral Contraceptive User | The duration were calculated and averaged for each testing visit. Change was evaluated by regressing the duration simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) active pill, and (2) inactive pill. Average and standard deviation for each phase is reported. | Active pill, Inactive pill |
| Change in Flexion Reflex Latency in Oral Contraceptive User | The latency measured from the onset of the stimulus were calculated and averaged for each testing visit. Change was evaluated by regressing the latency simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) active pill, and (2) inactive pill. Average and standard deviation for each phase is reported. | Active pill, Inactive pill |
| Change in Steadiness of Isometric Force Production at 20% of Maximum Voluntary Contraction in Oral Contraceptive User | Steadiness of the exerted force is quantified using coefficient of variation. Change was evaluated by regressing the steadiness simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) active pill, and (2) inactive pill. Average and standard deviation for each phase is reported. | Active pill, Inactive pill |
| Number of Positive Ovulation | Urinary ovulation kits is used to verify the ovulatory cycles and identify the approximate day of ovulation of the NOC group. | Follicular |
| Change in Muscle Twitch Time to Peak Torque in Non Oral Contraceptive User | Change was evaluated by regressing the time to peak torque simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) follicular phase, and (2) luteal phase. Average and standard deviation for each phase is reported. | Follicular, Luteal |
| Change in Muscle Twitch Half Relaxation Time in Non Oral Contraceptive User | Change was evaluated by regressing the half relaxation time simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) follicular phase, and (2) luteal phase. Average and standard deviation for each phase is reported. | Follicular, Luteal |
| Change in Muscle Twitch Peak Torque in Oral Contraceptive User | Change was evaluated by regressing the peak torque simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) active pill, and (2) inactive pill. Average and standard deviation for each phase is reported. | Active pill, Inactive pill |
| Change in Muscle Twitch Time to Peak Torque in Oral Contraceptive User | Change was evaluated by regressing the time to peak torque simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) active pill, and (2) inactive pill. Average and standard deviation for each phase is reported. | Active pill, Inactive pill |
| Change in Muscle Twitch Half Relaxation Time in Oral Contraceptive User | Change was evaluated by regressing the half relaxation time simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) active pill, and (2) inactive pill. Average and standard deviation for each phase is reported. | Active pill, Inactive pill |
| Physician Decision |
|
| Lack of adherence to study protocol |
|
| BG001 | Oral Contraceptive (OC) | Females: ages 18-39 years, who are on a stable hormonal contraceptive regimen for 6 months (oral, transdermal or vaginal) and moderately active. Exclusion criteria: History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, history of disordered eating, of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease), history of or current diabetes, started or stopped taking oral contraceptives within the previous 6 months, participate in high impact endurance training, or currently participating in competitive level sports. |
| BG002 | Male | Ages 18-39. Exclusion criteria: History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, history of disordered eating, of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease), history of or current diabetes, pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, medications that lower seizure threshold. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Oral Contraceptive (OC) | Females: ages 18-39 years, who are on a stable hormonal contraceptive regimen for 6 months (oral, transdermal or vaginal) and moderately active. Exclusion criteria: History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, history of disordered eating, of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease), history of or current diabetes, started or stopped taking oral contraceptives within the previous 6 months, participate in high impact endurance training, or currently participating in competitive level sports. |
| OG002 | Male | Males: Ages 18-39. Exclusion criteria: History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, history of disordered eating, of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease), history of or current diabetes, pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, and medications that lower seizure threshold. |
|
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| Primary | Change in Stretch Reflex at Relaxed State | Muscle stretch reflex (MSR) was calculated by dividing the root mean squared (RMS) value of the electromyogram (EMG) response with the RMS of the muscle's EMG during maximal voluntary contraction and the force of the tapper used to elicit the reflex. Change was evaluated by regressing the ratio simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. Average and standard deviation for each menstrual phase is reported. | Participants in NOC group. | Posted | Mean | Standard Deviation | ratio to RMS MVC and tapper force | Follicular, Luteal |
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| Primary | Change in Spinal Motor Neuron Excitability in Non Oral Contraceptive User | The spinal motor neuron excitability was measured by calculating the ratio between the maximum peak-to-peak value of H reflex and the maximum peak-to-peak value of M wave. Change was evaluated by regressing the ratio simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. Average and standard deviation for each menstrual phase is reported. | Participants in NOC group. | Posted | Mean | Standard Deviation | ratio to the max peak-to-peak M wave | Follicular, Luteal |
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| Primary | Normalized Conditioned Motor Evoked Potential in Male and Female | The conditioned motor evoked potential (MEP) at each inter-stimulus interval (ISI) was normalized to MEP obtained from unconditioned stimulation. The difference between male and female groups was evaluated using a 2 (male vs. female) x 7 (ISI) repeated measures ANOVA. Average and standard deviation for each ISI reported. | Participants in NOC and male groups. | Posted | Mean | Standard Deviation | ratio to the unconditioned stimulus MEP | menses period for female, day 1 for male |
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| Primary | Change in Spinal Motor Neuron Excitability in Oral Contraceptive User | The spinal motor neuron excitability was measured by calculating the ratio between the maximum peak-to-peak value of H reflex and the maximum peak-to-peak value of M wave. Change was evaluated by regressing the ratio simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. Average and standard deviation for active and inactive pill phase are reported. | Participants in OC group. | Posted | Mean | Standard Deviation | ratio to the max peak-to-peak M wave | Active pill, Inactive pill |
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| Secondary | Change in Steadiness of Isometric Force Production at 20% of Maximum Voluntary Contraction in Non Oral Contraceptive User | Steadiness of the exerted force is quantified using coefficient of variation. Change was evaluated by regressing the steadiness simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) follicular phase, and (2) luteal phase. Average and standard deviation for each phase is reported. | Participants in NOC group. | Posted | Mean | Standard Deviation | percentage (%) | Follicular, Luteal |
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| Secondary | Change in Flexion Reflex Root Mean Squared Value in Non Oral Contraceptive User | The root mean squared (RMS) value were calculated and averaged for each testing visit. Change was evaluated by regressing the RMS simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) follicular phase, and (2) luteal phase. Average and standard deviation for each phase is reported. | Participants in NOC group. | Posted | Mean | Standard Deviation | millivolt | Follicular, Luteal |
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| Secondary | Change in Flexion Reflex Duration in Non Oral Contraceptive User | The duration were calculated and averaged for each testing visit. Change was evaluated by regressing the duration simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) follicular phase, and (2) luteal phase. Average and standard deviation for each phase is reported. | Participants in NOC group. | Posted | Mean | Standard Deviation | milliseconds | Follicular, Luteal |
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| Secondary | Change in Flexion Reflex Latency in Non Oral Contraceptive User | The latency measured from the onset of the stimulus were calculated and averaged for each testing visit. Change was evaluated by regressing the latency simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) follicular phase, and (2) luteal phase. Average and standard deviation for each phase is reported. | Participants in NOC group. | Posted | Mean | Standard Deviation | milliseconds | Follicular, Luteal |
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| Secondary | Change in Flexion Reflex Root Mean Squared Value in Oral Contraceptive User | The root mean squared (RMS) value were calculated and averaged for each testing visit. Change was evaluated by regressing the RMS simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) active pill, and (2) inactive pill. Average and standard deviation for each phase is reported. | Participants in OC group. | Posted | Mean | Standard Deviation | millivolt | Active pill, Inactive pill |
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| Secondary | Change in Flexion Reflex Duration in Oral Contraceptive User | The duration were calculated and averaged for each testing visit. Change was evaluated by regressing the duration simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) active pill, and (2) inactive pill. Average and standard deviation for each phase is reported. | Participants in OC group. | Posted | Mean | Standard Deviation | milliseconds | Active pill, Inactive pill |
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| Secondary | Change in Flexion Reflex Latency in Oral Contraceptive User | The latency measured from the onset of the stimulus were calculated and averaged for each testing visit. Change was evaluated by regressing the latency simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) active pill, and (2) inactive pill. Average and standard deviation for each phase is reported. | Participants in OC group. | Posted | Mean | Standard Deviation | milliseconds | Active pill, Inactive pill |
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| Other Pre-specified | Change in Muscle Twitch Peak Torque in Non Oral Contraceptive User | Change was evaluated by regressing the peak torque simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) follicular phase, and (2) luteal phase. Average and standard deviation for each phase is reported. | Participants in NOC group. | Posted | Mean | Standard Deviation | Nm | Follicular, Luteal |
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| Other Pre-specified | Number of Positive Ovulation | Urinary ovulation kits is used to verify the ovulatory cycles and identify the approximate day of ovulation of the NOC group. | Participants in NOC group. | Posted | Number | positive ovulation | Follicular |
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| Other Pre-specified | Change in Muscle Twitch Time to Peak Torque in Non Oral Contraceptive User | Change was evaluated by regressing the time to peak torque simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) follicular phase, and (2) luteal phase. Average and standard deviation for each phase is reported. | Participants in NOC group. | Posted | Mean | Standard Deviation | milliseconds | Follicular, Luteal |
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| Other Pre-specified | Change in Muscle Twitch Half Relaxation Time in Non Oral Contraceptive User | Change was evaluated by regressing the half relaxation time simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) follicular phase, and (2) luteal phase. Average and standard deviation for each phase is reported. | Participants in NOC group. | Posted | Mean | Standard Deviation | milliseconds | Follicular, Luteal |
|
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| Other Pre-specified | Change in Muscle Twitch Peak Torque in Oral Contraceptive User | Change was evaluated by regressing the peak torque simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) active pill, and (2) inactive pill. Average and standard deviation for each phase is reported. | Participants in OC group. | Posted | Mean | Standard Deviation | Nm | Active pill, Inactive pill |
|
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| Other Pre-specified | Change in Muscle Twitch Time to Peak Torque in Oral Contraceptive User | Change was evaluated by regressing the time to peak torque simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) active pill, and (2) inactive pill. Average and standard deviation for each phase is reported. | Participants in OC group. | Posted | Mean | Standard Deviation | milliseconds | Active pill, Inactive pill |
|
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| Other Pre-specified | Change in Muscle Twitch Half Relaxation Time in Oral Contraceptive User | Change was evaluated by regressing the half relaxation time simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) active pill, and (2) inactive pill. Average and standard deviation for each phase is reported. | Participants in OC group. | Posted | Mean | Standard Deviation | milliseconds | Active pill, Inactive pill |
|
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|
|
| Secondary | Change in Steadiness of Isometric Force Production at 20% of Maximum Voluntary Contraction in Oral Contraceptive User | Steadiness of the exerted force is quantified using coefficient of variation. Change was evaluated by regressing the steadiness simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. The analyses was performed during (1) active pill, and (2) inactive pill. Average and standard deviation for each phase is reported. | Participants in OC group. | Posted | Mean | Standard Deviation | percentage (%) | Active pill, Inactive pill |
|
|
|
|
| Primary | Changes in Intracortical Facilitation (ICF) During the Follicular Phase | The conditioned motor evoked potential (MEP) at each inter-stimulus interval (ISI) was normalized to MEP obtained from unconditioned stimulation. Change was evaluated by regressing the normalized conditioned motor evoked potential amplitude at each ISI with estradiol concentration. Average and standard deviation for each ISI reported. | Participants in NOC group. | Posted | Mean | Standard Deviation | ratio to the unconditioned stimulus MEP | day 1 menses up to day with highest estradiol concentration |
|
|
|
|
| Primary | Change in Stretch Reflex at Active State | Muscle stretch reflex (MSR) was calculated by dividing the root mean squared (RMS) value of the electromyogram (EMG) response with the RMS of the muscle's EMG during maximal voluntary contraction and the force of the tapper used to elicit the reflex. Change was evaluated by regressing the ratio simultaneously on estradiol and progesterone concentrations, and estradiol x progesterone interaction. Average and standard deviation for each menstrual phase is reported. | Participants in NOC group. | Posted | Mean | Standard Deviation | ratio to RMS MVC and tapper force | Follicular, Luteal |
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| 0 |
| 61 |
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | Oral Contraceptive (OC) | Females: ages 18-39 years, who are on a stable hormonal contraceptive regimen for 6 months (oral, transdermal or vaginal) and moderately active. Exclusion criteria: History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, history of disordered eating, of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease), history of or current diabetes, started or stopped taking oral contraceptives within the previous 6 months, participate in high impact endurance training, or currently participating in competitive level sports. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Male | Ages 18-39. Exclusion criteria: History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, history of disordered eating, of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease), history of or current diabetes, pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, medications that lower seizure threshold. | 0 | 11 | 0 | 11 | 0 | 11 |
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| Wald test |
| <0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| >0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| 10 ms |
|
| 15 ms |
|
| 20 ms |
|
| 25 ms |
|
| 30 ms |
|
| Wald test |
| <0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| <0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| >0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| >0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| <0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| >0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| <0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| <0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| >0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| >0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| <0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| >0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| >0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| >0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Wald test |
| >0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |
| Title | Measurements |
|---|---|
|
| 25 ms |
|
| 30 ms |
|
| Wald test |
| >0.05 |
| Other |
Generalized estimating equation (GEE) with log link function and exchangeable correlation structure. |