Sd-Premens: Prevalence of Premenstrual Syndrome in Women of Reproductive Age

Sponsor
Université de Reims Champagne-Ardenne (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06117215
Collaborator
(none)
2,000
1
5
400.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Data collection

Detailed Description

The main aim is to describe the prevalence of premenstrual syndrome among women of reproductive age.

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Prevalence of Premenstrual Syndrome in Women of Reproductive Age
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
women of reproductive age

women of reproductive age

Other: Data collection
data collection

Outcome Measures

Primary Outcome Measures

  1. premenstrual syndrome [Day 0]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • women in childbearing age, i.e., menstrual or secondary amenorrhoea, non-menopausal

  • Over 18 years of age

  • Agreeing to participate in the study

Exclusion Criteria:
  • Menopause

  • Having had a hysterectomy

  • With primary amenorrhea

  • Protected by law

  • Refusing to participate in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ufr Medecine Urca Reims France 51100

Sponsors and Collaborators

  • Université de Reims Champagne-Ardenne

Investigators

  • Principal Investigator: Kristner Pauline, Dr, CH Épernay

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Université de Reims Champagne-Ardenne
ClinicalTrials.gov Identifier:
NCT06117215
Other Study ID Numbers:
  • 2023_RIPH_014_Sd-Premens
First Posted:
Nov 3, 2023
Last Update Posted:
Nov 3, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Université de Reims Champagne-Ardenne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2023