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Combined Oral Contraceptives and Fluoxetine Versus Combined Oral Contraceptives in Severe Premenstrual Syndrome

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ClinicalTrials.gov Identifier: NCT02488538
Recruitment Status : Recruiting
First Posted : July 2, 2015
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

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.

Condition or disease Intervention/treatment Phase
Premenstrual Syndrome Drug: Combined oral contraceptives Drug: Fluoxetine Drug: Combined oral contraceptives placebo Drug: Fluoxetine placebo Procedure: Daily record of severity of problems Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2015
Estimated Primary Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
Active Comparator: Combined oral contraceptives and Fuoxetine
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. .
Drug: Combined oral contraceptives
Women will receive COC containing drospirenone daily for 21 days starting from the 3rd day of menstruation

Drug: Fluoxetine
women will receive oral fluoxetine 20 mg daily

Procedure: Daily record of severity of problems
Women will record their symptoms daily using the daily record of severity of symptoms.

Active Comparator: Combined oral contraceptives
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
Drug: Combined oral contraceptives
Women will receive COC containing drospirenone daily for 21 days starting from the 3rd day of menstruation

Drug: Fluoxetine placebo
women will receive a daily oral placebo similar in size, color and structure to fluoxetine.

Procedure: Daily record of severity of problems
Women will record their symptoms daily using the daily record of severity of symptoms.

Placebo Comparator: Placebo
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.
Drug: Combined oral contraceptives placebo
women will receive oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation

Drug: Fluoxetine placebo
women will receive a daily oral placebo similar in size, color and structure to fluoxetine.

Procedure: Daily record of severity of problems
Women will record their symptoms daily using the daily record of severity of symptoms.




Primary Outcome Measures :
  1. Cured PMS [ Time Frame: 6 months after starting treatment. ]
    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.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  • History of deep venous thrombosis, known liver, kidney or heart disease.
  • Allergy to COC or fluoxetine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488538


Locations
Egypt
BeniSuef University hospitals Recruiting
BeniSuef, Egypt
Contact: Nesreen AA Shehata, MD    +2001227866337    nesoomar@yahoo.com   
Principal Investigator: Nesreen AA Shehata, MD         
Cairo University Hospitals Recruiting
Cairo, Egypt
Contact: AbdelGany MA Hassan, MRCOG, MD    00217801604    abdelgany2@gmail.com   
Principal Investigator: AbdelGany MA Hassan, MRCOG, MD         
Sponsors and Collaborators
Cairo University

Publications:
Responsible Party: AbdelGany Hassan, Lecturer of Gynecology and Obstetrics, Cairo University
ClinicalTrials.gov Identifier: NCT02488538     History of Changes
Other Study ID Numbers: PMS 1
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Syndrome
Premenstrual Syndrome
Disease
Pathologic Processes
Menstruation Disturbances
Contraceptive Agents
Contraceptives, Oral
Fluoxetine
Drospirenone
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics