Overview

Combined Oral Contraceptives and Fluoxetine Versus Combined Oral Contraceptives in Severe Premenstrual Syndrome

Status:
Unknown status
Trial end date:
1969-12-31
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 receive COC containing drospirenone (drospirenone 3mg+Ethinylestradiol 0.03mg; Yasmin® ScheringAG, Egypt) daily for 21 days starting from the 3rd day of menstruation in addition to oral fluoxetine 20 mg daily. Group 2 will receive COC containing drospirenone 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 . 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
Fluoxetine