Combined Oral Contraceptives and Fluoxetine Versus Combined Oral Contraceptives in Severe Premenstrual Syndrome
Premenstrual Syndrome
About this trial
This is an interventional treatment trial for Premenstrual Syndrome
Eligibility Criteria
Inclusion Criteria:
- Severe PMS
- Regular periods
Exclusion Criteria:
- Underlying psychiatric disease.
- Body mass index > 35.
- Women on combined oral contraceptives.
- History of deep venous thrombosis.
- History of deep venous thrombosis, known liver, kidney or heart disease.
- Allergy to COC or fluoxetine
Sites / Locations
- BeniSuef University hospitalsRecruiting
- Cairo University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
Combined oral contraceptives and Fuoxetine
Combined oral contraceptives
Placebo
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.