NCT05928650

Brief Summary

The purpose of this study is to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 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

May 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

June 26, 2023

Last Update Submit

August 30, 2023

Conditions

Keywords

Menstrual functionSerum estradiol levelsSprintersLong Marathon RunnersNon-Athletic Females

Outcome Measures

Primary Outcomes (5)

  • serum estradiol level

    Blood samples were obtained on the 2nd day of the menstrual cycle at 10.00 a.m. following overnight fasting and rest. The athletic females were instructed to refrain from performing strenuous exercise on the day of sampling. Blood samples were separated and stored at -80°C till analysis of serum estradiol levels. Serum estradiol levels were measured to evaluate the menstrual function. The manufacturer indicated the following reference intervals for healthy females: Estradiol 40-350 pg/ml.

    3 months

  • Menstrual history characteristics

    The age at menarche (in years), the number of menstrual cycles in the past year, and the length of menstrual cycles (in days) were collected through a self-administered questionnaire to evaluate the menstrual status of each female participant.

    3 months

  • Age of participation to sport

    It was taken in years from each female athlete through a self-administered questionnaire.

    3 months

  • Weekly training workload

    It was taken in hours per week from each female athlete through a self-administered questionnaire.

    3 months

  • Training experience

    The training experience of the athlete was then calculated by subtracting her age of participation in sport from her chronological age.

    3 months

Study Arms (3)

Sprinters

Sprinters

Other: Evaluation of menstrual function

Long marathon runners

Long marathon runners

Other: Evaluation of menstrual function

Non-athletic Females

Non-athletic Females

Other: Evaluation of menstrual function

Interventions

Evaluation of serum estradiol levels and menstrual history characteristics between sprinters, long marathon runners and non-athletes.

Long marathon runnersNon-athletic FemalesSprinters

Eligibility Criteria

Age16 Years - 19 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility is based on self-representation of gender identity.
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Egyptian sprinters, long marathon runners, and non-athletic females

You may qualify if:

  • Virginal females.
  • Their age ranged from 16 to 19years.
  • All females had the same socio-economic status.
  • For athletic groups only:
  • They have been starting the practice of sport at least one year before the onset of menarche.

You may not qualify if:

  • Females who had been used oral contraceptives or any hormonal treatment in the previous six months.
  • Smoking.
  • History of chronic disease.
  • Having any psychiatric problems.
  • For athletic groups only:
  • injured females who were absent from training for at least three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Menstruation Disturbances

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Doaa Osman

    Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 3, 2023

Study Start

May 1, 2023

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations