NCT03832972

Brief 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. And that the performance in women using birth control pills, not will variated in the period where they are taking pills (day 1-21).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

October 22, 2018

Last Update Submit

May 17, 2022

Conditions

Performance

Keywords

menstrual cycleEstrogenperformancevariation

Outcome Measures

Primary Outcomes (2)

  • Change in jumping height

    measuring of change in muscle power

    8 times per month, 2 to 5 days between measurements

  • Change in grip strength

    measuring of changes in muscle strength

    8 times per month, 2 to 5 days between measurements

Secondary Outcomes (2)

  • Change in hormone levels

    8 time per month, 2 to 5 days between measurements

  • Change in motivation by questionnaire

    8 times per month, 2 to 5 days between measurements

Study Arms (2)

Women using birth control

Other: estrogen level

Women not using birthcontrol

Other: estrogen level

Interventions

estrogen levelOTHER

Women are tested at different times in their menstrual cycle, if there is a cohesion between performance and level of estrogen

Also known as: Physical tests
Women not using birthcontrolWomen using birth control

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy women, 10 using 2. generations birth control pills and 30 not using any kind of hormonal protection.

You may qualify if:

  • Women
  • years of age
  • BMI 18.5-25.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section of Sport Science

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 35213728DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2018

First Posted

February 6, 2019

Study Start

October 1, 2018

Primary Completion

December 20, 2019

Study Completion

April 1, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations

DK(1)