Overview

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

Status:
Unknown status
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Cairo University
Treatments:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Drospirenone
Ethinyl Estradiol
Fluoxetine