None listed
Conditions
Brief summary
210 women with premenstrual syndrome will be randomly divided into 3 groups: group 1 will receive combined oral contraceptives and fluoxetine, group 2 will receive fluoxetine only, and group 3 will receive a placebo. The change in symptoms will be compared among the groups using DRSP.
Interventions
210 women with premenstrual syndrome (PMS) will be prospectively diagnosed. Diagnosis will be done using the daily record of severity of problems (DRSP), women will be asked to fill the diary for 2 months. Only women with 30% increase in the DRSP score in the week before menses in both months will be diagnosed as having PMS. Women will be randomly divided into 3 groups, group 1 will receive combined oral contraceptives (gynera) tablets, 75mg Gestodene and 0.03mg ethinylestradiol per tablet orally once daily for 21 days starting starting from the second day of menstruation in addition to the continuous use of fluoxetine (Prozac) oral tablets 50mg daily, the second group will receive continuous fluoxetine oral tablets 50mg daily and the third group will receive a placebo daily. Treatment will be continued for 3 months in all the groups. Monitoring of adherence to treatment will be monitored by asking the patients to return the empty tablet strips.Symptoms of premenstrual syndrome will be assesses 3 months after starting the treatment
Sponsors
Study design
Eligibility
Inclusion criteria
Age 20-40 years Premenstrual syndrome Nulligravida
Exclusion criteria
Diabetes Hypertension Liver disease History of DVT Allergy to fluoxetine