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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Does Adding Combined Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome? A Double Blind Placebo Controlled Study.

Brief 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.

Detailed Summary:

Premenstrual syndrome (PMS) manifests with distressing physical, behavioral and psychological symptoms, in the absence of organic or underlying psychiatric disease, which regularly recur during luteal phase of each menstrual cycle and disappear or significantly improve by the end of menstruation. Approximately 85-90 % of women may experience premenstrual emotional and physical changes in their reproductive age and the prevalence of severe PMS ranges from 3% to 8%.

The etiology of PMS is unknown but cyclical ovarian activity and the effect of estradiol and progesterone on serotonin and gamma-amino butyric acid are key factors. Absence of PMS before puberty, in pregnancy and after the menopause supports a role of cyclical ovarian activity in PMS etiology. PMS symptoms include psychological symptoms like mood swings, irritability, depression and feeling out of control; physical symptoms like breast tenderness, bloating and headaches; and behavioral symptoms like reduced visuospatial and cognitive ability. To diagnose PMS, symptoms should be recorded prospectively over two cycles using a symptom diary. Several symptom diaries exist but the Daily Record of Severity of Problems (DRSP) is reliable, simple for patients and recommended by the Royal College of Obstetricians and Gynecologists.

Life style modifications like stress reduction, exercise, and low carbohydrate diet have been suggested for management of PMS but have not been thoroughly investigated. Pharmacological treatments of PMS include COC, serotonin reuptake inhibitors gonadotrophin-releasing hormone agonists, anxiolytics, and diuretics. Various other treatments have also been recommended including acupuncture, dietary supplements, and bright light therapy, PMS treatment should be based on individual symptoms, concomitant medical history and the need of contraception.
Sponsor: Cairo University

Current Primary Outcome: Improved PMS [ Time Frame: Monthly for 6 months. ]

Women will be asked to document their symptoms daily using DRSP. Cured PMS will be diagnosed if day 1 DRSP score is< 50 or if the luteal phase score is not at least 30 percent greater than the follicular phase score.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cairo University

Dates:
Date Received: September 25, 2015
Date Started: October 2015
Date Completion: September 2017
Last Updated: July 3, 2016
Last Verified: July 2016