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Trial record 36 of 53 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND containing

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562053
Recruitment Status : Unknown
Verified July 2016 by AbdelGany Hassan, Cairo University.
Recruitment status was:  Recruiting
First Posted : September 29, 2015
Last Update Posted : July 6, 2016
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 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.

Condition or disease Intervention/treatment Phase
Premenstrual Syndrome Drug: Fluoxetine Drug: Combined oral contraceptives Drug: Placebo 1 Drug: Placebo 2 Phase 3

  Show Detailed Description

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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: Does Adding Combined Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome? A Double Blind Placebo Controlled Study.
Study Start Date : October 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
Active Comparator: Fluoxetine
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.
Drug: Fluoxetine
Women will receive oral fluoxetine 20 mg daily.

Drug: Placebo 1
Women will receive oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation

Active Comparator: Combined oral contraceptives and fluoxetine
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.
Drug: Fluoxetine
Women will receive oral fluoxetine 20 mg daily.

Drug: Combined oral contraceptives
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

Placebo Comparator: Placebo
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
Drug: Placebo 1
Women will receive oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation

Drug: Placebo 2
Women will receive a daily oral placebo similar to fluoxetine




Primary Outcome Measures :
  1. 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.



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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, 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): NCT02562053


Contacts
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Contact: AbdelGany M Hassan, MRCOG, MD +201017801604 abdelgany2@gmail.com

Locations
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Egypt
BeniSuef University hospitals Recruiting
BeniSuef, Egypt
Contact: Nesreen AA Shehata, MD    +2001227866337    nesoomar@yahoo.com   
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:
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Responsible Party: AbdelGany Hassan, Lecturer of Gynecology and Obstetrics, Cairo University
ClinicalTrials.gov Identifier: NCT02562053     History of Changes
Other Study ID Numbers: PMS 2
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Drospirenone
Syndrome
Premenstrual Syndrome
Disease
Pathologic Processes
Menstruation Disturbances
Fluoxetine
Contraceptive Agents
Contraceptives, Oral
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
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics