Premenstrual syndrome
Conditions
Interventions
Placebo or fluoxetine capsules in na interval of up to 14 days before the presumable first day of the next menstrual period. One group of 10 volunteers will use placebo and the other groups (with 10 v
Drug
D26.660
Sponsors
Hospital das Clínicas de Ribeirão Preto
Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (FAEPA)
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Non pregnant women; 18 to 40 years; fill retrospectivily the criteria for premenstrual syndrome according to the American College of Obstetricians and Gynecology
Exclusion criteria
Exclusion criteria: Continuous use of oral contraceptive or brake between pills less than 7 days; current use of injectable contraceptive (monthly or quarterly); current use of contraceptive implants; current use of drosperinone; use of hormonal DIU; current daily use of benzodiazepines; current use of drug or any substance which could interfere with esteroidal and/ or fluoxetine's metabolism; currency major depressive episode, current generality anxiety, bipolar disorder, schizophrenia or other psychotic disorders, current obsessive-compulsive disorder, current postraumatic stress disorder, current use of ilicit drugs or alcohol (except current use of tobacco); mild or severe intelectual disability; migraine (except the headache which occurs only in the premenstrual days); epilepsy; pregnancy; women who are breastfeeding; history of intolerance or severe side effects to fluoxetine; history or current other medical condition which could threaten the volunteer's safety during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of Score on Daily Record of Severity of Problems, a scale for evaluation of the premenstrual's symptons. For that, will be calculated the area under the curve. | — |
Secondary
| Measure | Time frame |
|---|---|
| Score on UKU scale of side effects. We will use one-way ANOVA for the score e chi-square analysis for especific side effects | — |
Countries
Brazil
Contacts
Public ContactMaria Clara;Vinicius Faleiros;Guapo
Hospital das Clínicas de Ribeirão Preto;Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (FAEPA)
Outcome results
None listed