MedTrace Logo

Dienogest Versus Luteal Phase Fluoxetine in the Management of Premenstrual Syndrome

NCT02427334 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2020-12-01

No results posted yet for this study

Summary

Two hundreds and ten women with premenstrual syndrome will be randomly divided into 3 equal groups using computer generated random numbers. Group 1 will receive oral dienogest (visanne® Bayer, Germany) 2mg for 14 days starting from the 15th day of menstruation, Group 2 will receive fluoxetine (Prozac® Lilly, UK) 20mg and group 3 will receive an oral placebo foe 14 days starting from the 15th day of menstruation.

Conditions

  • Premenstrual Syndrome

Interventions

DRUG

Dienogest

women will receive oral dienogest 2mg for 14 days starting from the 15th day of menstruation

DRUG

Fluoxetine

women will receive oral fluoxetine 20mg for 14 days starting from the 15th day of menstruation

DRUG

Placebo

women will receive oral placebo for 14 days starting from the 15th day of menstruation

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02427334 on ClinicalTrials.gov