A clinical trial using Fluoxetine in patients with Premenstrual Syndrome

Phase 2

Recruiting

• Conditions: Premenstrual syndrome; N94.3

• Registration Number: RBR-6pmz49
• Lead Sponsor: Hospital das Clínicas de Ribeirão Preto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified