Menstrual CycleMCPBTNCT05936424
Menstrual Cycle Phase Based Training
A study testing Unilateral Resistance Exercise Leg in people with Menstrual Cycle and Resistance Exercise, run by McMaster University at 1 site in Canada.
Trial summary
The primary purpose of this study is to employ state-of-the-art methods to fill current knowledge gaps on the effects of the menstrual cycle on resistance exercise training adaptations. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle, Resistance Exercise
- What is being tested?
- Unilateral Resistance Exercise Leg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women, between the ages of 18 - 30 years (inclusive)
- Have a body mass index (BMI) between 18-35 kg·m2 (inclusive)
- Be in general good health as assessed by a general health questionnaire
- Non-smoking
- Regular menstrual cycle (21-35 days, inclusive)
- Not using hormonal contraceptives
- Willing and able to provide informed consent
Who cannot join
- Use of tobacco or related products.
- Ineligible to participate in physical activity based on get active questionnaire (GAQ)
- Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements.
- Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
- Use of hormonal contraceptives
- Currently pregnant
Show all 14Show fewer
- Training more than 3x/week for the past 6 months.
- Have any electronic medical or metal implants
- A history of neuromuscular disorders or muscle/bone wasting diseases
- The use of any medications known to affect protein metabolism (glucocorticoids, non-steroidal anti-inflammatory medication, or prescription strength acne medication, etc.)
- A (family) history of thrombosis
- The use of anticoagulant medications
- Excessive alcohol consumption (>21 units/wk)
- History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1
About this study
Official title: Investigating the Effects of Menstrual Cycle Phase Based Training on Muscle Strength and Hypertrophy
The primary purpose of this study is to employ state-of-the-art methods to fill current knowledge gaps on the effects of the menstrual cycle on resistance exercise training adaptations. This work will reduce the sex gap present in exercise physiology, improving women's health information by yielding a deeper understanding of the effect of female physiology on exercise adaptations and subsequent health benefits.
Employing a unilateral training design, participant's will have their legs randomized to one of four groups: non-exercise control (CON), exercise control (EX), Follicular based training (FOL), Luteal based training (LUT)
Researchers will compare these conditions to see if there are greater benefits to prioritizing resistance training around phases of the menstrual cycle,
Read the detailed description
Participants will be required to track their menstrual cycle (MC) for a total of four MC's. MC tracking will be done via self-reported menstrual onset and ovulation strips. During the first tracking cycle participants will be asked to come in at three time points for blood draws to confirm hormone concentrations and familiarize them with the strength testing protocol. Following the tracking month participant legs will then be blocked randomized based on leg skeletal muscle mass and strength into one of four groups: non-exercise control (CON), exercise control (EX), follicular based training (FOL) and luteal based training (LUT). Participants will then be asked to come in ~2x per week (4-6x/menstrual cycle phase) for resistance training under direct supervision. Participants will be trained in unilateral leg extension and unilateral leg press. For legs randomized to the FOL and LUT group, training volume will be manipulated by changing the number of sets completed. The FOL group will train high volume (~20+ sets per week) in their follicular phase and low volume (~5 sets/week) in their luteal phase, the opposite will be true for the LUT group. Muscle biopsies will be taken both prior to and after training to assess changes in fiber cross-sectional area (CSA) and capillarization. Segmental body composition will be assessed both prior and post training using bioelectrical impedance analysis (BIA), dual x-ray absorptiometry (DXA), and vastus lateralis cross-sectional area and thickness. Muscle strength will also be assessed pre and post training using the isokinetic dynamometer, unilateral one-repetition maximum (1RM) leg extension and unilateral 1RM leg press.
- Conditions
- Menstrual Cycle, Resistance Exercise
- Being tested
- Unilateral Resistance Exercise Leg, Non-Exercise Control Leg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Resistance Exercise LegOther
One will perform unilateral resistance exercise
Non-Exercise Control LegOther
One leg will serve as a non-exercise control
| Study group | Role | What they receive |
|---|---|---|
| Non-Exercise Control (CON) | Active comparator | This condition will serve as a non-exercise control and will not be performing resistance exercise training (RET) Receives: Other: Non-Exercise Control Leg |
| Follicular Based Training (FOL) | Experimental | This condition will have high volume of RET (20 weekly sets) during the follicular phase and low volume during the luteal phase of the participant's menstrual cycle. Receives: Other: Unilateral Resistance Exercise Leg |
| Luteal Based Training (LUT) | Experimental | This condition will have high volume of RET (20 weekly sets) during the luteal phase and low volume during the follicular phase of the participant's menstrual cycle. Receives: Other: Unilateral Resistance Exercise Leg |
| Exercise Control (EX) | Experimental | This condition will have consistent training volume (12 weekly sets) throughout the duration of the study, regardless of what phase of the menstrual cycle the participant is in. Receives: Other: Unilateral Resistance Exercise Leg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Hypertrophy
The investigators will be measuring participant's muscle cross-sectional area of the quadriceps pre and post training intervention via ultrasound (US)
US is used to measure skeletal muscle thickness and cross-sectional area. A trained and experienced study investigator will perform the US measures. US will be used to measure the cross-sectional area of the vastus lateralis muscle on both legs. After remaining supine for 15-minute, your feet will be positioned in a custom foot-hold apparatus that prevents depression of the thigh against the bed. Mid-thigh will be identified via palpation. A marker will be used to draw a line down your leg, perpendicular to the surface of the bed, and horizontal markings will be made every 2 cm serving as a guideline for ultrasound probe placement. Ultrasound images will be taken at each horizontal marking and used to measure the muscle cross-sectional area of the quadriceps.
Measured: 16 weeks
Muscular Strength
The investigators will be measuring participant's muscle strength via one-repetition maximum testing using the unilateral leg press.
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Sep 2023
- Primary completion15 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial (RCT), within-between subject design. Legs will be randomized to one of four groups: non-exercise control (CON), exercise control (EX), Follicular based training (FOL), Luteal based training (LUT)
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936424
- Sponsor's protocol ID
- 16355
- Acronym
- MCPBT
- Status last verified
- Aug 2025
- First submitted
- 22 Jun 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participants will be assigned a unique subject identification number (ID), and therefore, other researchers involved with analyses will not have access to identifying participant information.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Menstrual Cycle Phase Based Training on Muscle Strength and Hypertrophy
- ClinicalTrials.gov ID
- NCT05936424
- Acronym / sponsor ID
- MCPBT / 16355
- Conditions
- Menstrual Cycle, Resistance Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to employ state-of-the-art methods to fill current knowledge gaps on the effects of the menstrual cycle on resistance exercise training adaptations. This work will reduce the sex gap present in exercise physiology, improving women's health information by yielding a deeper understanding of the effect of female physiology on exercise adaptations and subsequent health benefits.
Employing a unilateral training design, participant's will have their legs randomized to one of four groups: non-exercise control (CON), exercise control (EX), Follicular based training (FOL), Luteal based training (LUT)
Researchers will compare these conditions to see if there are greater benefits to prioritizing resistance training around phases of the menstrual cycle,
Detailed description
Participants will be required to track their menstrual cycle (MC) for a total of four MC's. MC tracking will be done via self-reported menstrual onset and ovulation strips. During the first tracking cycle participants will be asked to come in at three time points for blood draws to confirm hormone concentrations and familiarize them with the strength testing protocol. Following the tracking month participant legs will then be blocked randomized based on leg skeletal muscle mass and strength into one of four groups: non-exercise control (CON), exercise control (EX), follicular based training (FOL) and luteal based training (LUT). Participants will then be asked to come in ~2x per week (4-6x/menstrual cycle phase) for resistance training under direct supervision. Participants will be trained in unilateral leg extension and unilateral leg press. For legs randomized to the FOL and LUT group, training volume will be manipulated by changing the number of sets completed. The FOL group will train high volume (~20+ sets per week) in their follicular phase and low volume (~5 sets/week) in their luteal phase, the opposite will be true for the LUT group. Muscle biopsies will be taken both prior to and after training to assess changes in fiber cross-sectional area (CSA) and capillarization. Segmental body composition will be assessed both prior and post training using bioelectrical impedance analysis (BIA), dual x-ray absorptiometry (DXA), and vastus lateralis cross-sectional area and thickness. Muscle strength will also be assessed pre and post training using the isokinetic dynamometer, unilateral one-repetition maximum (1RM) leg extension and unilateral 1RM leg press.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized controlled trial (RCT), within-between subject design. Legs will be randomized to one of four groups: non-exercise control (CON), exercise control (EX), Follicular based training (FOL), Luteal based training (LUT)
| Arm | Type | Receives |
|---|---|---|
| Non-Exercise Control (CON) | Active comparator | Other: Non-Exercise Control LegThis condition will serve as a non-exercise control and will not be performing resistance exercise training (RET) |
| Follicular Based Training (FOL) | Experimental | Other: Unilateral Resistance Exercise LegThis condition will have high volume of RET (20 weekly sets) during the follicular phase and low volume during the luteal phase of the participant's menstrual cycle. |
| Luteal Based Training (LUT) | Experimental | Other: Unilateral Resistance Exercise LegThis condition will have high volume of RET (20 weekly sets) during the luteal phase and low volume during the follicular phase of the participant's menstrual cycle. |
| Exercise Control (EX) | Experimental | Other: Unilateral Resistance Exercise LegThis condition will have consistent training volume (12 weekly sets) throughout the duration of the study, regardless of what phase of the menstrual cycle the participant is in. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women, between the ages of 18 - 30 years (inclusive)
- Have a body mass index (BMI) between 18-35 kg·m2 (inclusive)
- Be in general good health as assessed by a general health questionnaire
- Non-smoking
- Regular menstrual cycle (21-35 days, inclusive)
Key exclusion criteria (14 listed)
- Use of tobacco or related products.
- Ineligible to participate in physical activity based on get active questionnaire (GAQ)
- Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements.
- Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
- Use of hormonal contraceptives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral Resistance Exercise LegOne will perform unilateral resistance exercise | Other | Exercise Control (EX), Follicular Based Training (FOL), Luteal Based Training (LUT) |
| Non-Exercise Control LegOne leg will serve as a non-exercise control | Other | Non-Exercise Control (CON) |
Primary outcome
Muscle Hypertrophy
Time frame: 16 weeks
The investigators will be measuring participant's muscle cross-sectional area of the quadriceps pre and post training intervention via ultrasound (US) US is used to measure skeletal muscle thickness and cross-sectional area. A trained and experienced study investigator will perform the US measures. US will be used to measure the cross-sectional area of the vastus lateralis muscle on both legs. After remaining supine for 15-minute, your feet will be positioned in a custom foot-hold apparatus that prevents depression of the thigh against the bed. Mid-thigh will be identified via palpation. A marker will be used to draw a line down your leg, perpendicular to the surface of the bed, and horizontal markings will be made every 2 cm serving as a guideline for ultrasound probe placement. Ultrasound images will be taken at each horizontal marking and used to measure the muscle cross-sectional area of the quadriceps.
Muscular Strength
Time frame: 16 Weeks
The investigators will be measuring participant's muscle strength via one-repetition maximum testing using the unilateral leg press.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No. All participants will be assigned a unique subject identification number (ID), and therefore, other researchers involved with analyses will not have access to identifying participant information.
Related trials for Menstrual Cycle
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Recruiting
Delivering tAN to Reduce HMB: The LUNA Study
Heavy Menstrual Bleeding
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women.
Premenstrual Syndrome, Menstrual Discomfort
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral Resistance Exercise Leg in people with Menstrual Cycle and Resistance Exercise, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Hypertrophy (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.