search
Back to results

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

Primary Purpose

Premenstrual Syndrome

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Fluoxetine
Combined oral contraceptives
Placebo 1
Placebo 2
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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, 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

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Fluoxetine

Combined oral contraceptives and fluoxetine

Placebo

Arm Description

Women will receive daily oral fluoxetine 20 mg in addition to an oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation.

Women will receive COC containing drospirenone (drospirenone 3mg+Ethinylestradiol 0.03mg; Yasmin® Schering AG, Egypt) daily for 21 days starting from the 3rd day of menstruation in addition to oral fluoxetine 20 mg daily.

Women 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

Outcomes

Primary Outcome Measures

Improved PMS
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.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2015
Last Updated
July 3, 2016
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT02562053
Brief Title
Does Adding Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome?
Official Title
Does Adding Combined Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome? A Double Blind Placebo Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Description
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. The objective of the study is to investigate the role of the combined use of fluoxetine and COC versus fluoxetine in the treatment of PMS. 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) 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. To diagnose PMS women will be asked to document their symptoms daily for 2 months using the daily record of severity of problems (DRSP). DRSP is a questionnaire comprised of 25 physical and emotional symptoms including impairment of physical and social activities, women will be asked to give a score of 1 to 6 for each symptom 1 = not at all, 2 = minimal, 3 = mild, 4 = moderate, 5 = severe, 6 = extreme. The investigators will add the symptoms scores of the first day of menses and PMS will be excluded if the score is< 50. If the total score is greater than 50, the investigators will recorded two cycles of symptoms. If more than three items have an average score of more than 3 (mild) during the luteal phase, the investigators will add the scores of five-day intervals during the luteal and follicular phases. PMS will be diagnosed when the luteal phase score is 30 percent greater than the follicular phase score in the 2 months. All women will have a psychiatric review and women with underlying psychiatric disease will be excluded. Women who are unable to interact socially or professionally because of the symptoms will be considered to have severe PMS. All married women will be advised to use barrier contraceptives. All women will be asked to take the medications for 6 months and record their symptoms using the DRSP. Women with suboptimal social or professional interaction will be considered having moderate PMS. Women with no interference with the social or professional activity will be considered as having mild PMS. Women with day 1 DRSP score <50 and women with average luteal phase scores <30% more than the average proliferative scores will not be considered having PMS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluoxetine
Arm Type
Active Comparator
Arm Description
Women will receive daily oral fluoxetine 20 mg in addition to an oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation.
Arm Title
Combined oral contraceptives and fluoxetine
Arm Type
Active Comparator
Arm Description
Women will receive COC containing drospirenone (drospirenone 3mg+Ethinylestradiol 0.03mg; Yasmin® Schering AG, Egypt) daily for 21 days starting from the 3rd day of menstruation in addition to oral fluoxetine 20 mg daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Women 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
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Description
Women will receive oral fluoxetine 20 mg daily.
Intervention Type
Drug
Intervention Name(s)
Combined oral contraceptives
Intervention Description
women will receive COC containing drospirenone (drospirenone 3mg+Ethinylestradiol 0.03mg; Yasmin® Schering AG, Egypt) daily for 21 days starting from the 3rd day of menstruation
Intervention Type
Drug
Intervention Name(s)
Placebo 1
Intervention Description
Women will receive oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation
Intervention Type
Drug
Intervention Name(s)
Placebo 2
Intervention Description
Women will receive a daily oral placebo similar to fluoxetine
Primary Outcome Measure Information:
Title
Improved PMS
Description
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.
Time Frame
Monthly for 6 months.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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, known liver, kidney or heart disease. Allergy to COC or fluoxetine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AbdelGany M Hassan, MRCOG, MD
Phone
+201017801604
Email
abdelgany2@gmail.com
Facility Information:
Facility Name
BeniSuef University hospitals
City
BeniSuef
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nesreen AA Shehata, MD
Phone
+2001227866337
Email
nesoomar@yahoo.com
Facility Name
Cairo University Hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AbdelGany MA Hassan, MRCOG, MD
Phone
00217801604
Email
abdelgany2@gmail.com
First Name & Middle Initial & Last Name & Degree
AbdelGany MA Hassan, MRCOG, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23744611
Citation
Marjoribanks J, Brown J, O'Brien PM, Wyatt K. Selective serotonin reuptake inhibitors for premenstrual syndrome. Cochrane Database Syst Rev. 2013 Jun 7;2013(6):CD001396. doi: 10.1002/14651858.CD001396.pub3.
Results Reference
background
PubMed Identifier
15508358
Citation
Yonkers KA. Management strategies for PMS/PMDD. J Fam Pract. 2004 Sep;Suppl:S15-20. No abstract available.
Results Reference
background
PubMed Identifier
12715267
Citation
Steiner M, Brown E, Trzepacz P, Dillon J, Berger C, Carter D, Reid R, Stewart D. Fluoxetine improves functional work capacity in women with premenstrual dysphoric disorder. Arch Womens Ment Health. 2003 Feb;6(1):71-7. doi: 10.1007/s00737-002-0162-2.
Results Reference
background
PubMed Identifier
22336820
Citation
Lopez LM, Kaptein AA, Helmerhorst FM. Oral contraceptives containing drospirenone for premenstrual syndrome. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD006586. doi: 10.1002/14651858.CD006586.pub4.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs