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Does Adding Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome?

NCT02562053 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2016-07-06

No results posted yet for this study

Summary

Three hundred women with severe premenstrual syndrome will be divided into 3 groups using computer generated random numbers. Group 1 will receiveCombined oral contraceptives (COC) containing drospirenone (drospirenone 3mg+Ethinylestradiol 0.03mg) daily for 21 days starting from the 3rd day of menstruation in addition to oral fluoxetine 20 mg daily. Group 2 will receive fluoxetine 20 mg daily in addition to an oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation.Group 3 will receive oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation in addition to a daily oral placebo similar in size, color and structure to fluoxetine.

Conditions

  • Premenstrual Syndrome

Interventions

DRUG

Fluoxetine

Women will receive oral fluoxetine 20 mg daily.

DRUG

Combined oral contraceptives

women will receive COC containing drospirenone (drospirenone 3mg+Ethinylestradiol 0.03mg; Yasmin® Schering AG, Egypt) daily for 21 days starting from the 3rd day of menstruation

DRUG

Placebo 1

Women will receive oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation

DRUG

Placebo 2

Women will receive a daily oral placebo similar to fluoxetine

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Egypt

Study Locations

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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 NCT02562053 on ClinicalTrials.gov