NCT06117215

Brief Summary

The menstrual cycle is a recurring process in the lives of women from puberty until menopause. This cycle can cause various discomforts, including premenstrual syndrome. Described differently, premenstrual syndrome is a collection of physical and psychological symptoms that occur during the luteal phase of the menstrual cycle and subside upon the arrival of menstruation. This definition is conditioned by the existence of a free interval of at least one week between the end of the period and the appearance of these symptoms, as well as a global impairment of functioning and quality of life for women. The impact on the personal, social, and professional lives of affected women, as well as the pain and discomfort it causes, may be perceived as insignificant or normal by women. Therefore, few women report the existence of these disorders to healthcare professionals. As the subject is not approached, these women are not taken care of even though therapeutic solutions could be proposed. This pathology affects a large number of women, but its prevalence differs greatly depending on the studies conducted on the subject, suggesting a lack of knowledge of this syndrome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 30, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

October 30, 2023

Last Update Submit

November 2, 2023

Conditions

Keywords

Premenstrual syndromewomen reproductive ageprevalence

Outcome Measures

Primary Outcomes (1)

  • premenstrual syndrome

    Prevalence of premenstrual syndrome defined as a set of physical, psychic and behavioral symptoms, appearing in the luteal phase of the menstrual cycle (that is, in the days before menstruation) and yielding with them, conditioned by a sufficient severity to alter the overall functioning and quality of life of women and must be present over at least 2 consecutive cycles.

    Day 0

Study Arms (1)

women of reproductive age

women of reproductive age

Other: Data collection

Interventions

data collection

women of reproductive age

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women of chilbearing age

You may qualify if:

  • women in childbearing age, i.e., menstrual or secondary amenorrhoea, non-menopausal
  • Over 18 years of age
  • Agreeing to participate in the study

You may not qualify if:

  • Menopause
  • Having had a hysterectomy
  • With primary amenorrhea
  • Protected by law
  • Refusing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufr Medecine Urca

Reims, 51100, France

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Kristner Pauline, Dr

    CH Épernay

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 3, 2023

Study Start

December 1, 2023

Primary Completion

February 1, 2024

Study Completion

May 1, 2024

Last Updated

November 3, 2023

Record last verified: 2023-10

Locations