Combined Oral Contraceptives and Fluoxetine Versus Combined Oral Contraceptives in Severe Premenstrual Syndrome
The Synergistic Use of Combined Oral Contraceptives and Fluoxetine Versus Combined Oral Contraceptives in the Management of Severe Premenstrual Syndrome: A Randomized Double Blind Placebo Controlled Trial
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
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
June 27, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedJanuary 23, 2017
January 1, 2017
2 years
June 27, 2015
January 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Cured 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.
6 months after starting treatment.
Study Arms (3)
Combined oral contraceptives and Fuoxetine
ACTIVE COMPARATORGroup 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. .
Combined oral contraceptives
ACTIVE COMPARATORGroup 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
Placebo
PLACEBO COMPARATORGroup 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.
Interventions
Women will receive COC containing drospirenone daily for 21 days starting from the 3rd day of menstruation
women will receive oral fluoxetine 20 mg daily
women will receive oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation
women will receive a daily oral placebo similar in size, color and structure to fluoxetine.
Women will record their symptoms daily using the daily record of severity of symptoms.
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.
- 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 (3)
Lustyk MK, Widman L, Paschane A, Ecker E. Stress, quality of life and physical activity in women with varying degrees of premenstrual symptomatology. Women Health. 2004;39(3):35-44. doi: 10.1300/J013v39n03_03.
PMID: 15256354BACKGROUNDEndicott J, Nee J, Harrison W. Daily Record of Severity of Problems (DRSP): reliability and validity. Arch Womens Ment Health. 2006 Jan;9(1):41-9. doi: 10.1007/s00737-005-0103-y. Epub 2005 Sep 20.
PMID: 16172836BACKGROUNDSmith SS, Gong QH, Hsu FC, Markowitz RS, ffrench-Mullen JM, Li X. GABA(A) receptor alpha4 subunit suppression prevents withdrawal properties of an endogenous steroid. Nature. 1998 Apr 30;392(6679):926-30. doi: 10.1038/31948.
PMID: 9582073BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
June 27, 2015
First Posted
July 2, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2017
Last Updated
January 23, 2017
Record last verified: 2017-01