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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06117215
Other study ID # 2023_RIPH_014_Sd-Premens
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date May 1, 2024

Study information

Verified date October 2023
Source Université de Reims Champagne-Ardenne
Contact Barbe Coralie
Phone 0326913665
Email coralie.barbe@univ-reims.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2000
Est. completion date May 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data collection
data collection

Locations

Country Name City State
France Ufr Medecine Urca Reims

Sponsors (1)

Lead Sponsor Collaborator
Université de Reims Champagne-Ardenne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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