Role of Sex Hormones Along the Neuromechanical Axis
Conditions
Keywords
Sex Hormones
Brief summary
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.
Interventions
None listed
Sponsors
University of Texas Southwestern Medical Center
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Females: ages 18-39 years, who are eumenorrheic (regular monthly cycles of 24-35 days) or on a stable hormonal contraceptive regimen for 6 months (oral, transdermal or vaginal), no history of pregnancy, moderately active (less than 7 hours of vigorous physical activity per week) * 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, current smoker, history of disordered eating, history of stress fracture in the lower limb, history of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease). * For female participants only: Point of care screening for anemia will be completed, and individuals with hemoglobin levels \<11.6 g/dl will be excluded from participating in the study. * Specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Short-interval Intracortical Inhibition (SICI) During the Follicular Phase | day 1 menses up to day with highest estradiol concentration | 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. |
| Change in Stretch Reflex at Relaxed State | Follicular, Luteal | 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. |
| Change in Spinal Motor Neuron Excitability in Non Oral Contraceptive User | Follicular, Luteal | 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. |
| Normalized Conditioned Motor Evoked Potential in Male and Female | menses period for female, day 1 for male | 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. |
| Change in Spinal Motor Neuron Excitability in Oral Contraceptive User | Active pill, Inactive pill | 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. |
| Changes in Intracortical Facilitation (ICF) During the Follicular Phase | day 1 menses up to day with highest estradiol concentration | 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. |
| Change in Stretch Reflex at Active State | Follicular, Luteal | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Steadiness of Isometric Force Production at 20% of Maximum Voluntary Contraction in Non Oral Contraceptive User | Follicular, Luteal | 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. |
| Change in Flexion Reflex Root Mean Squared Value in Non Oral Contraceptive User | Follicular, Luteal | 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. |
| Change in Flexion Reflex Duration in Non Oral Contraceptive User | Follicular, Luteal | 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. |
| Change in Flexion Reflex Latency in Non Oral Contraceptive User | Follicular, Luteal | 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. |
| Change in Flexion Reflex Root Mean Squared Value in Oral Contraceptive User | Active pill, Inactive pill | 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. |
| Change in Flexion Reflex Duration in Oral Contraceptive User | Active pill, Inactive pill | 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. |
| Change in Flexion Reflex Latency in Oral Contraceptive User | Active pill, Inactive pill | 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. |
| Change in Steadiness of Isometric Force Production at 20% of Maximum Voluntary Contraction in Oral Contraceptive User | Active pill, Inactive pill | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYasin Dhaher, Ph.D.
University of Texas Southwestern Medical Center
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 61 |
| 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. | 30 |
| 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. | 11 |
| Total | 102 |
Baseline characteristics
| Characteristic | Non-Oral Contraceptive (NOC) | Oral Contraceptive (OC) | Male | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 30 Participants | 11 Participants | 102 Participants |
| Age, Continuous | 27 years STANDARD_DEVIATION 5 | 27 years STANDARD_DEVIATION 4 | 28 years STANDARD_DEVIATION 5 | 27 years STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 5 Participants | 0 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 21 Participants | 11 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 4 Participants | 0 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 5 Participants | 8 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 4 Participants | 0 Participants | 17 Participants |
| Race (NIH/OMB) White | 32 Participants | 19 Participants | 2 Participants | 53 Participants |
| Region of Enrollment United States | 61 participants | 30 participants | 11 participants | 102 participants |
| Sex: Female, Male Female | 61 Participants | 30 Participants | 0 Participants | 91 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 11 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 30 | 0 / 11 |
| other Total, other adverse events | 0 / 61 | 0 / 30 | 0 / 11 |
| serious Total, serious adverse events | 0 / 61 | 0 / 30 | 0 / 11 |
Outcome results
Primary
Change in Muscle Stretch Reflex in Non Oral Contraceptive User
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.
Time frame: Follicular, Luteal
Population: Female participants who are not taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Oral Contraceptive (NOC) | Change in Muscle Stretch Reflex in Non Oral Contraceptive User | Luteal | 0.0138 ratio to RMS MVC and tapper force | Standard Deviation 0.0136 |
| Non-Oral Contraceptive (NOC) | Change in Muscle Stretch Reflex in Non Oral Contraceptive User | Follicular | 0.0164 ratio to RMS MVC and tapper force | Standard Deviation 0.0144 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained during follicular phase.p-value: >0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained during luteal phase.p-value: <0.05Wald test
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.
Time frame: Follicular, Luteal
Population: Female participants who are not taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Oral Contraceptive (NOC) | Change in Spinal Motor Neuron Excitability in Non Oral Contraceptive User | Follicular | 0.6 ratio to the max peak-to-peak M wave | Standard Deviation 0.24 |
| Non-Oral Contraceptive (NOC) | Change in Spinal Motor Neuron Excitability in Non Oral Contraceptive User | Luteal | 0.61 ratio to the max peak-to-peak M wave | Standard Deviation 0.25 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained during follicular phase.p-value: >0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained during luteal phase.p-value: >0.05Wald test
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.
Time frame: Active pill, Inactive pill
Population: Female participants who are taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Contraceptive (OC) | Change in Spinal Motor Neuron Excitability in Oral Contraceptive User | Active pill | 0.67 ratio to the max peak-to-peak M wave | Standard Deviation 0.19 |
| Oral Contraceptive (OC) | Change in Spinal Motor Neuron Excitability in Oral Contraceptive User | Inactive pill | 0.67 ratio to the max peak-to-peak M wave | Standard Deviation 0.16 |
Comparison: Significance was accepted for p values \<0.05. Data obtained during active pill phase.p-value: >0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data obtained during inactive pill phase.p-value: <0.05Wald test
Primary
Changes in Normalized Conditioned Motor Evoked Potential 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.
Time frame: day 1 menses up to day with highest estradiol concentration
Population: Female participants who are not taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Oral Contraceptive (NOC) | Changes in Normalized Conditioned Motor Evoked Potential During the Follicular Phase | 7 ms | 1.11 ratio to the unconditioned stimulus MEP | Standard Deviation 0.2 |
| Non-Oral Contraceptive (NOC) | Changes in Normalized Conditioned Motor Evoked Potential During the Follicular Phase | 10 ms | 1.32 ratio to the unconditioned stimulus MEP | Standard Deviation 0.38 |
| Non-Oral Contraceptive (NOC) | Changes in Normalized Conditioned Motor Evoked Potential During the Follicular Phase | 15 ms | 1.54 ratio to the unconditioned stimulus MEP | Standard Deviation 0.51 |
| Non-Oral Contraceptive (NOC) | Changes in Normalized Conditioned Motor Evoked Potential During the Follicular Phase | 20 ms | 1.46 ratio to the unconditioned stimulus MEP | Standard Deviation 0.59 |
| Non-Oral Contraceptive (NOC) | Changes in Normalized Conditioned Motor Evoked Potential During the Follicular Phase | 3 ms | 0.83 ratio to the unconditioned stimulus MEP | Standard Deviation 0.22 |
| Non-Oral Contraceptive (NOC) | Changes in Normalized Conditioned Motor Evoked Potential During the Follicular Phase | 25 ms | 1.37 ratio to the unconditioned stimulus MEP | Standard Deviation 0.62 |
| Non-Oral Contraceptive (NOC) | Changes in Normalized Conditioned Motor Evoked Potential During the Follicular Phase | 4 ms | 0.93 ratio to the unconditioned stimulus MEP | Standard Deviation 0.24 |
| Non-Oral Contraceptive (NOC) | Changes in Normalized Conditioned Motor Evoked Potential During the Follicular Phase | 2 ms | 0.78 ratio to the unconditioned stimulus MEP | Standard Deviation 0.21 |
| Non-Oral Contraceptive (NOC) | Changes in Normalized Conditioned Motor Evoked Potential During the Follicular Phase | 30 ms | 1.28 ratio to the unconditioned stimulus MEP | Standard Deviation 0.64 |
| Non-Oral Contraceptive (NOC) | Changes in Normalized Conditioned Motor Evoked Potential During the Follicular Phase | 5 ms | 1.03 ratio to the unconditioned stimulus MEP | Standard Deviation 0.26 |
| Non-Oral Contraceptive (NOC) | Changes in Normalized Conditioned Motor Evoked Potential During the Follicular Phase | 6 ms | 1.08 ratio to the unconditioned stimulus MEP | Standard Deviation 0.37 |
Comparison: Significance was accepted for p values \<0.05.p-value: >0.05F-test
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.
Time frame: menses period for female, day 1 for male
Population: Female participants who are not taking oral contraceptives and male participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Oral Contraceptive (NOC) | Normalized Conditioned Motor Evoked Potential in Male and Female | 10 ms | 1.3 ratio to the unconditioned stimulus MEP | Standard Deviation 0.35 |
| Non-Oral Contraceptive (NOC) | Normalized Conditioned Motor Evoked Potential in Male and Female | 20 ms | 1.48 ratio to the unconditioned stimulus MEP | Standard Deviation 0.71 |
| Non-Oral Contraceptive (NOC) | Normalized Conditioned Motor Evoked Potential in Male and Female | 7 ms | 1.06 ratio to the unconditioned stimulus MEP | Standard Deviation 0.2 |
| Non-Oral Contraceptive (NOC) | Normalized Conditioned Motor Evoked Potential in Male and Female | 25 ms | 1.38 ratio to the unconditioned stimulus MEP | Standard Deviation 0.74 |
| Non-Oral Contraceptive (NOC) | Normalized Conditioned Motor Evoked Potential in Male and Female | 15 ms | 1.5 ratio to the unconditioned stimulus MEP | Standard Deviation 0.51 |
| Non-Oral Contraceptive (NOC) | Normalized Conditioned Motor Evoked Potential in Male and Female | 30 ms | 1.26 ratio to the unconditioned stimulus MEP | Standard Deviation 0.74 |
| Non-Oral Contraceptive (NOC) | Normalized Conditioned Motor Evoked Potential in Male and Female | 2 ms | 0.75 ratio to the unconditioned stimulus MEP | Standard Deviation 0.22 |
| Male | Normalized Conditioned Motor Evoked Potential in Male and Female | 30 ms | 0.99 ratio to the unconditioned stimulus MEP | Standard Deviation 0.3 |
| Male | Normalized Conditioned Motor Evoked Potential in Male and Female | 2 ms | 1.02 ratio to the unconditioned stimulus MEP | Standard Deviation 0.2 |
| Male | Normalized Conditioned Motor Evoked Potential in Male and Female | 7 ms | 1.17 ratio to the unconditioned stimulus MEP | Standard Deviation 0.31 |
| Male | Normalized Conditioned Motor Evoked Potential in Male and Female | 10 ms | 1.35 ratio to the unconditioned stimulus MEP | Standard Deviation 0.58 |
| Male | Normalized Conditioned Motor Evoked Potential in Male and Female | 15 ms | 1.24 ratio to the unconditioned stimulus MEP | Standard Deviation 0.58 |
| Male | Normalized Conditioned Motor Evoked Potential in Male and Female | 20 ms | 1.22 ratio to the unconditioned stimulus MEP | Standard Deviation 0.52 |
| Male | Normalized Conditioned Motor Evoked Potential in Male and Female | 25 ms | 1.16 ratio to the unconditioned stimulus MEP | Standard Deviation 0.41 |
Comparison: Significance was accepted for p values \<0.05.p-value: >0.05F-test
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.
Time frame: Follicular, Luteal
Population: Female participants who are not taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Oral Contraceptive (NOC) | Change in Flexion Reflex Duration in Non Oral Contraceptive User | Follicular | 36.58 milliseconds | Standard Deviation 13.24 |
| Non-Oral Contraceptive (NOC) | Change in Flexion Reflex Duration in Non Oral Contraceptive User | Luteal | 35.60 milliseconds | Standard Deviation 13.11 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained during follicular phase.p-value: >0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained during luteal phase.p-value: >0.05Wald test
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.
Time frame: Active pill, Inactive pill
Population: Female participants who are taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Contraceptive (OC) | Change in Flexion Reflex Duration in Oral Contraceptive User | Active pill | 30 milliseconds | Standard Deviation 5.71 |
| Oral Contraceptive (OC) | Change in Flexion Reflex Duration in Oral Contraceptive User | Inactive pill | 28.2 milliseconds | Standard Deviation 6.23 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained during active pill phase.p-value: >0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.p-value: <0.05Wald test
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.
Time frame: Follicular, Luteal
Population: Female participants who are not taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Oral Contraceptive (NOC) | Change in Flexion Reflex Latency in Non Oral Contraceptive User | Follicular | 81.96 milliseconds | Standard Deviation 7.17 |
| Non-Oral Contraceptive (NOC) | Change in Flexion Reflex Latency in Non Oral Contraceptive User | Luteal | 80.73 milliseconds | Standard Deviation 7.63 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained during follicular phase.p-value: >0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained during luteal phase.p-value: <0.05Wald test
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.
Time frame: Active pill, Inactive pill
Population: Female participants who are taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Contraceptive (OC) | Change in Flexion Reflex Latency in Oral Contraceptive User | Active pill | 77.7 milliseconds | Standard Deviation 5.59 |
| Oral Contraceptive (OC) | Change in Flexion Reflex Latency in Oral Contraceptive User | Inactive pill | 76.4 milliseconds | Standard Deviation 6.98 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained during active pill phase.p-value: <0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.p-value: <0.05Wald test
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.
Time frame: Follicular, Luteal
Population: Female participants who are not taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Oral Contraceptive (NOC) | Change in Flexion Reflex Root Mean Squared Value in Non Oral Contraceptive User | Follicular | 0.093 millivolt | Standard Deviation 0.066 |
| Non-Oral Contraceptive (NOC) | Change in Flexion Reflex Root Mean Squared Value in Non Oral Contraceptive User | Luteal | 0.111 millivolt | Standard Deviation 0.08 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained during follicular phase.p-value: >0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained during luteal phase.p-value: >0.05Wald test
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.
Time frame: Active pill, Inactive pill
Population: Female participants who are taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Contraceptive (OC) | Change in Flexion Reflex Root Mean Squared Value in Oral Contraceptive User | Active pill | 0.107 millivolt | Standard Deviation 0.074 |
| Oral Contraceptive (OC) | Change in Flexion Reflex Root Mean Squared Value in Oral Contraceptive User | Inactive pill | 0.083 millivolt | Standard Deviation 0.034 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained during active pill phase.p-value: >0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.p-value: >0.05Wald test
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.
Time frame: Follicular, Luteal
Population: Female participants who are not taking oral contraceptive.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Oral Contraceptive (NOC) | Change in Steadiness of Isometric Force Production at 20% of Maximum Voluntary Contraction in Non Oral Contraceptive User | Follicular | 2.2 percentage (%) | Standard Deviation 0.7 |
| Non-Oral Contraceptive (NOC) | Change in Steadiness of Isometric Force Production at 20% of Maximum Voluntary Contraction in Non Oral Contraceptive User | Luteal | 2.2 percentage (%) | Standard Deviation 0.9 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained during follicular phase.p-value: >0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained during luteal phase.p-value: <0.05Wald test
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.
Time frame: Active pill, Inactive pill
Population: Female participants who are taking oral contraceptive.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Contraceptive (OC) | Change in Steadiness of Isometric Force Production at 20% of Maximum Voluntary Contraction in Oral Contraceptive User | Active pill | 1.9 percentage (%) | Standard Deviation 0.8 |
| Oral Contraceptive (OC) | Change in Steadiness of Isometric Force Production at 20% of Maximum Voluntary Contraction in Oral Contraceptive User | Inactive pill | 1.9 percentage (%) | Standard Deviation 0.7 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained during active pill phase.p-value: <0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.p-value: >0.05Wald test
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.
Time frame: Follicular, Luteal
Population: Female participants who are not taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Oral Contraceptive (NOC) | Change in Muscle Twitch Half Relaxation Time in Non Oral Contraceptive User | Follicular | 119 milliseconds | Standard Deviation 21.3 |
| Non-Oral Contraceptive (NOC) | Change in Muscle Twitch Half Relaxation Time in Non Oral Contraceptive User | Luteal | 115 milliseconds | Standard Deviation 20 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained from follicular phase.p-value: >0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained from luteal phase.p-value: <0.05Wald test
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.
Time frame: Active pill, Inactive pill
Population: Female participants who are taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Contraceptive (OC) | Change in Muscle Twitch Half Relaxation Time in Oral Contraceptive User | Active pill | 124 milliseconds | Standard Deviation 21.5 |
| Oral Contraceptive (OC) | Change in Muscle Twitch Half Relaxation Time in Oral Contraceptive User | Inactive pill | 128 milliseconds | Standard Deviation 18 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained during active pill phase.p-value: <0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.p-value: >0.05Wald test
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.
Time frame: Follicular, Luteal
Population: Female participants who are not taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Oral Contraceptive (NOC) | Change in Muscle Twitch Peak Torque in Non Oral Contraceptive User | Follicular | 12.7 Nm | Standard Deviation 2.49 |
| Non-Oral Contraceptive (NOC) | Change in Muscle Twitch Peak Torque in Non Oral Contraceptive User | Luteal | 12.4 Nm | Standard Deviation 2.44 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained from follicular phase.p-value: >0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained from luteal phase.p-value: >0.05Wald test
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.
Time frame: Active pill, Inactive pill
Population: Female participants who are taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Contraceptive (OC) | Change in Muscle Twitch Peak Torque in Oral Contraceptive User | Active pill | 13.9 Nm | Standard Deviation 5.06 |
| Oral Contraceptive (OC) | Change in Muscle Twitch Peak Torque in Oral Contraceptive User | Inactive pill | 14.3 Nm | Standard Deviation 5.96 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.p-value: >0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained during active pill phase.p-value: >0.05Wald test
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.
Time frame: Follicular, Luteal
Population: Female participants who are not taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Oral Contraceptive (NOC) | Change in Muscle Twitch Time to Peak Torque in Non Oral Contraceptive User | Follicular | 94.6 milliseconds | Standard Deviation 14 |
| Non-Oral Contraceptive (NOC) | Change in Muscle Twitch Time to Peak Torque in Non Oral Contraceptive User | Luteal | 91 milliseconds | Standard Deviation 12.1 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained from follicular phase.p-value: >0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained from luteal phase.p-value: >0.05Wald test
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.
Time frame: Active pill, Inactive pill
Population: Female participants who are not taking oral contraceptives.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Contraceptive (OC) | Change in Muscle Twitch Time to Peak Torque in Oral Contraceptive User | Active pill | 98.1 milliseconds | Standard Deviation 19.2 |
| Oral Contraceptive (OC) | Change in Muscle Twitch Time to Peak Torque in Oral Contraceptive User | Inactive pill | 95 milliseconds | Standard Deviation 14.4 |
Comparison: Significance was accepted for p values \<0.05. Data is obtained during active pill phase.p-value: <0.05Wald test
Comparison: Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.p-value: >0.05Wald test
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.
Time frame: Follicular
Population: Female participants who are not taking oral contraceptives.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Oral Contraceptive (NOC) | Number of Positive Ovulation | 53 positive ovulation |