Does Adding Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome?
Does Adding Combined Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome? A Double Blind Placebo Controlled Study.
1 other identifier
interventional
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2015
CompletedFirst Posted
Study publicly available on registry
September 29, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedJuly 6, 2016
July 1, 2016
1.9 years
September 25, 2015
July 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Monthly for 6 months.
Study Arms (3)
Fluoxetine
ACTIVE COMPARATORWomen 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.
Combined oral contraceptives and fluoxetine
ACTIVE COMPARATORWomen 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.
Placebo
PLACEBO COMPARATORWomen 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
Interventions
Women will receive oral fluoxetine 20 mg daily.
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
Women will receive oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation
Eligibility Criteria
You may qualify if:
- Severe PMS
- Regular periods
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (2)
BeniSuef University hospitals
BeniSuef, Egypt
Cairo University Hospitals
Cairo, Egypt
Related Publications (4)
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.
PMID: 23744611BACKGROUNDYonkers KA. Management strategies for PMS/PMDD. J Fam Pract. 2004 Sep;Suppl:S15-20. No abstract available.
PMID: 15508358BACKGROUNDSteiner 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.
PMID: 12715267BACKGROUNDLopez 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.
PMID: 22336820BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Gynecology and Obstetrics
Study Record Dates
First Submitted
September 25, 2015
First Posted
September 29, 2015
Study Start
October 1, 2015
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
July 6, 2016
Record last verified: 2016-07