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CompletedNCT04455685LB2007Updated Jul 2, 2020

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

An observational study in Premenstrual Syndrome, sponsored by Libbs Farmacêutica LTDA. Completed at 1 site in Brazil. Open to female participants aged 20 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-02.

Sponsored by Libbs Farmacêutica LTDA · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
1,022
Ages
20 Years to 49 Years
Sex
Female
01

Study 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.

Read the detailed description

In Brazil and Latin America there are still 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, socioeconomic and sociocultural conditions of these women .

In the investigator's view, this study brings value not only to contribute to the understanding and demystification of PMS by society in general, but also for the professionals who assist these women. The data currently used in Brazil, and which are frequently used to guide public health policies, are mostly the result of research carried out in other countries, and which may not correspond to the national reality.

The information generated with this study may help to rethink behaviors to improve the health and quality of life of these women, at this stage in which comprehensive attention to the health and needs of this population should be given, often providing contraceptive methods that offer, as a benefit relief of symptoms related to PMS. The data from this research may also offer tools for decision making related to the need for early and effective treatment of PMS, whose disorders are associated with both the decrease in the present and future quality of life for the woman, as well as all of her family life, social and professional.

02

Conditions studied

  • Premenstrual Syndrome
03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,034 are open to participants now.

This study's enrollment of 1,022 is above the median of 102 across 2,211 observational studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Libbs Farmacêutica LTDA is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • The present study does not include exclusion criteria
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
1,022 participants (actual)
Patient registry
No

Interventions

  • Otheranonymised data collection

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 months

  2. 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.

    Time frame: 4 months

07

Study locations

1 site
  • Augusto Theodoro de Figueiredo
    São Paulo, 01140050, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04455685
Lead sponsor
Libbs Farmacêutica LTDA
Responsible party
Sponsor
First posted
Jul 2, 2020
Start date
Jun 29, 2020
Primary completion
Jun 29, 2020
Completion
Jun 29, 2020
Last update
Jul 2, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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