PerformanceNCT03832972
Performance During Menstrual Cycle
An observational study of Performance, run by University of Aarhus at 1 site in Denmark.
Trial summary
This project aims to investigate if muscle strength and muscle power fluctuate during the menstrual cycle. The hypothesis is that the greatest performance will be measured right before ovulation, and at it's lowest on day 1 and 2 of the menstrual cycle in women not using any form for hormonal protection. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Performance
- What is being tested?
- estrogen level
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2018to 1 Apr 2022
- Phase
- Observational
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women, 10 using 2. generations birth control pills and 30 not using any kind of hormonal protection.
Who may be able to join
- Women
- 18-35 years of age
- BMI 18.5-25.
Who cannot join
- Smoking
- hormonal or metabolic disorders
- chronic sickness
- use of medication
- breast feeding, vegetarians
- diet containing a lot of soja based products
- injuries which make it impossible to do the tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Variation in Performance During Menstrual Cycle
This project aims to investigate if muscle strength and muscle power fluctuate during the menstrual cycle.
The hypothesis is that the greatest performance will be measured right before ovulation, and at it's lowest on day 1 and 2 of the menstrual cycle in women not using any form for hormonal protection.
And that the performance in women using birth control pills, not will variated in the period where they are taking pills (day 1-21).
- Conditions
- Performance
- Being tested
- estrogen level
- Keywords
- menstrual cycle, Estrogen, performance, variation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estrogen levelOther
Also called Physical tests
Women are tested at different times in their menstrual cycle, if there is a cohesion between performance and level of estrogen
| Study group | Role | What they receive |
|---|---|---|
| Women using birth control | Not described Receives: Other: estrogen level | |
| Women not using birthcontrol | Not described Receives: Other: estrogen level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in jumping height
measuring of change in muscle power
Measured: 8 times per month, 2 to 5 days between measurements
Change in grip strength
measuring of changes in muscle strength
Measured: 8 times per month, 2 to 5 days between measurements
Secondary outcomes (2)
Change in hormone levels
measuring of changes in hormone levels during cycle
Measured: 8 time per month, 2 to 5 days between measurements
Change in motivation by questionnaire
measuring of changes in motivation for performing
Measured: 8 times per month, 2 to 5 days between measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Oct 2018
- Primary completion20 Dec 2019
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PerformanceStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Team Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832972
- Sponsor's protocol ID
- Estrogen2018
- Status last verified
- May 2022
- First submitted
- 22 Oct 2018
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He W, Dam TV, Thogersen R, Hansen M, Bertram HC. Fluctuations in Metabolites and Bone Markers Across the Menstrual Cycle in Eumenorrheic Women and Oral Contraceptive Users. J Clin Endocrinol Metab. 2022 May 17;107(6):1577-1588. doi: 10.1210/clinem/dgac112.
PubMed 35213728
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation in Performance During Menstrual Cycle
- ClinicalTrials.gov ID
- NCT03832972
- Acronym / sponsor ID
- Estrogen2018
- Conditions
- Performance
- Keywords
- menstrual cycle, Estrogen, performance, variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Team Denmark
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 6 Feb 2019 (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.
This project aims to investigate if muscle strength and muscle power fluctuate during the menstrual cycle.
The hypothesis is that the greatest performance will be measured right before ovulation, and at it's lowest on day 1 and 2 of the menstrual cycle in women not using any form for hormonal protection.
And that the performance in women using birth control pills, not will variated in the period where they are taking pills (day 1-21).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women using birth control | – | Other: estrogen level |
| Women not using birthcontrol | – | Other: estrogen level |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women, 10 using 2. generations birth control pills and 30 not using any kind of hormonal protection.
Key inclusion criteria (3 listed)
- Women
- 18-35 years of age
- BMI 18.5-25.
Key exclusion criteria (7 listed)
- Smoking
- hormonal or metabolic disorders
- chronic sickness
- use of medication
- breast feeding, vegetarians
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 |
|---|---|---|
| estrogen levelAlso: Physical testsWomen are tested at different times in their menstrual cycle, if there is a cohesion between performance and level of estrogen | Other | Women not using birthcontrol, Women using birth control |
Primary outcome
Change in jumping height
Time frame: 8 times per month, 2 to 5 days between measurements
measuring of change in muscle power
Change in grip strength
Time frame: 8 times per month, 2 to 5 days between measurements
measuring of changes in muscle strength
2 secondary outcomes
Change in hormone levels
Time frame: 8 time per month, 2 to 5 days between measurements
Change in motivation by questionnaire
Time frame: 8 times per month, 2 to 5 days between measurements
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 18 May 2022.
- Derived from this study: PubMed 35213728He W, Dam TV, Thogersen R, Hansen M, Bertram HC. Fluctuations in Metabolites and Bone Markers Across the Menstrual Cycle in Eumenorrheic Women and Oral Contraceptive Users. J Clin Endocrinol Metab. 2022 May 17;107(6):1577-1588. doi: 10.1210/clinem/dgac112.
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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?
An observational study of Performance, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 7 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 18 May 2022. 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 Denmark. 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?
Change in jumping height (time frame: 8 times per month, 2 to 5 days between measurements). 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?
On the ClinicalTrials.gov record for NCT03832972, which also lists 1 linked publication.
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 18 May 2022.