Prevalence of Self-reported Premenstrual Syndrome and Analysis of Somatic and Psychoemotional Symptoms

NCT04455685 | Completed

• 1 other identifier: LB2007
• Study Type: observational
• Target: 1,022
• Locations: 1 country
• Sites: 1

Brief Summary

In Brazil there are few published studies that study, the prevalence, symptoms and the population's knowledge about the premenstrual syndrome of women of reproductive age, and that correlate these data with the sociodemographic conditions of these women. In addition, given the complexity of the diagnosis of PMS, the prevalence of PMS in the Brazilian female population may be lower than the self-reported and published in these works, since not all women who believe they suffer from PMS fully comply with the criteria contemplated in the consensus for diagnosis of PMS. In this sense, this study aims to analyze the prevalence and intensity of frequent symptoms of PMS reported by the Brazilian female population. The information generated with this study may help to rethink behaviors to improve the health and quality of life of these women, as well as offer tools for decision making related to the need for early and effective treatment of PMS, whose disorders are associated with both the fall present and future quality of life for women, as well as all of their family, social and professional coexistence.

Conditions

Premenstrual Syndrome

Outcome Measures

Primary Outcomes (2)

• sociodemographic data

  Data from at least 1022 (one thousand and twenty-two) women, aged between 20 and 49 years old, living in the five regions of Brazil will be retrieved at random. This information will be organized in a data collection form developed for this study.

  4 months

• somatic and psychoemotional premenstrual symptoms data

  data related to somatic and psychoemotional premenstrual symptoms, with their intensity measured by a 4-point Likert scale (0 = none; 1 = mild; 2 = moderate; 3 = severe), degree of interference of these symptoms in daily life and whether the participants would take contraceptives as a method of treating PMS. These data will be organized in a data collection form prepared for this study.

  4 months

Interventions

anonymised data collection OTHER

The population of the present study corresponds to a sample of previous market research. Data from participants from the five main regions of Brazil (North, Northeast, Midwest, South, Southeast) will be selected at random and according to the sample size calculation.

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The population of the present study corresponds to a sample of previous market research. Data from participants from the five main regions of Brazil (North, Northeast, Midwest, South, Southeast) will be selected at random and according to the sample size calculation.

You may qualify if:

• Data from questionnaires that integrate the anonymous secondary database generated in the period between 20/02/2019 and 03/20/2020, of female participants aged between 20 and 49 years, in which all necessary information has been filled out according to the participant's profile.

Sponsors & Collaborators

• Libbs Farmacêutica LTDA: lead

Study Sites (1)

Augusto Theodoro de Figueiredo

São Paulo, 01140050, Brazil

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: June 29, 2020
• Primary Completion: June 29, 2020
• Study Completion: June 29, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-06

Locations

BR (1)