NCT04007471

Brief Summary

Dysmenorrhea or painful menstruation is a common symptom of menses. Dysmenorrhea is defined as a painful, cramping sensation in the lower abdomen or back associated with menstrual periods and is classified into primary and secondary types. Primary dysmenorrhea is painful menstrual periods not due to other diseases, and often occurs soon after menarche. Secondary dysmenorrhea is due to an underlying pelvic abnormality, such as endometriosis. Dysmenorrhea is the most common gynecological complaint. In many studies, the prevalence of primary dysmenorrhea varies between 34 % in 2010 in Egypt, 86.6% in 2002 in Switzerland, and 21% in 1999 in France. Nowadays, physiopathology is better understood, which suggests that the investigators have treatments Although dysmenorrhea is a common concern, many women never seek medical advice, even though treatments are easily available and simple. In fact, despite the high prevalence, dysmenorrhea is undertreated and even disregarded by health professionals, and the girls themselves, who may accept it as a normal part of the menstrual cycle. The pain occurs just before and/or during menstruation ; it can be mild to severe and is frequently associated with many other symptoms, like nausea, vomiting, headache, diarrhea, tiredness and has many consequences in wellbeing and school. Dysmenorrhea is known to be the first cause of absenteism from school, and appears to have many consequences and a real impact on women's daily activities, which is why it's a public health problem. Because of the lack of recent studies in France, the aim of this study is to evaluate the prevalence of adolescent dysmenorrhea. The investigators also assessed its severity, how adolescent girls experienced their menses, and how they manage their pain (seeking medical consultation, use of medication). The investigators used a self-assessment questionnaire in a cohort of high school girls, aged 15 to 19 years old, during April and May of 2019, in 8 private and public high schools in Ille-et-Vilaine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
979

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2019

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

April 13, 2023

Status Verified

July 1, 2019

Enrollment Period

23 days

First QC Date

July 1, 2019

Last Update Submit

April 11, 2023

Conditions

Keywords

DysmenorrheaPrimary dysmenorrheaSecondary dysmenorrheaPelvic painMenstrual painAdolescentEndometriosis

Outcome Measures

Primary Outcomes (1)

  • Prevalence of dysmenorrhea

    " During last past year, have you ever experienced pain in your lower abdomen or back associated with menstrual periods ? " " Never " - " Sometimes " - " Always "

    Inclusion day

Interventions

Anonymous questionnaire to determine the prevalence of dysmenorrhea of adolescent girls, to assess the severity of dysmenorrhea, how girls experience their menses, the consequences on daily living activities or at school, and how they manage their pain.

Eligibility Criteria

Age15 Years - 19 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Cohort of adolescent girls aged between 15 and 19 years old who go to a private or public highschool in Ille-et-Vilaine A sample of 960 girls were obtained

You may qualify if:

  • Adolescent girls aged between 15 and 19 years old
  • Menstruating adolescent girls
  • Accept participation
  • Schooled in one of the 8 randomised public and private high schools in Ille-et-Vilaine

You may not qualify if:

  • Girls under 15 or over 19 years old
  • If a girl or their parents didn't want their daughter to participate
  • Primary or secondary amenorrhea during more than 6 months in the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35000, France

Location

MeSH Terms

Conditions

DysmenorrheaPelvic PainEndometriosis

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Maud BIDET, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 5, 2019

Study Start

April 24, 2019

Primary Completion

May 17, 2019

Study Completion

May 17, 2019

Last Updated

April 13, 2023

Record last verified: 2019-07

Locations