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Trial record 78 of 101 for:    ETHINYL ESTRADIOL AND DROSPIRENONE

Comparison Between Oral Contraceptive Pills and Calcium Supplements in Treatment of Premenstrual Syndrome (PMS)

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ClinicalTrials.gov Identifier: NCT02089620
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

Tracking Information
First Submitted Date  ICMJE March 2, 2014
First Posted Date  ICMJE March 18, 2014
Last Update Posted Date August 11, 2015
Study Start Date  ICMJE May 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2014)
Improvement of premenstrual symptoms. [ Time Frame: 3 months after starting treatment. ]
Improvement of symptoms will be assessed by comparing the pre-treatment recorded DRSP with that recorded 3 months after starting treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02089620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Oral Contraceptive Pills and Calcium Supplements in Treatment of Premenstrual Syndrome
Official Title  ICMJE Calcium Supplements Versus Oral Contraceptive Pills Containing Drospirenone in Treating Mild to Moderate Premenstrual Syndrome: A Double Blind Randomized Placebo Controlled Trial
Brief Summary Premenstrual syndrome represents a group of problems affecting most of women in reproductive age. These problems include emotional and physical symptoms. In this study the efficacy of oral contraceptive pills and calcium supplements in relieving these symptoms will be assessed .
Detailed Description

Premenstrual syndrome (PMS) is defined as the recurrence of psychological and physical symptoms in the luteal phase, which remit in the follicular phase of the menstrual cycle [1].PMS will be prospectively diagnosed using the Royal college of Obstetricians and Gynecologists (RCOG) recommended daily record of severity of problems (DRSP) . Women will be asked to fill the diary for 2 months, only women with 30% increase in the DRSP score in the week before menses in both months will be diagnosed as having PMS.

Women with PMS will be invited to participate in the study.The invitation will include a clear full explanation of the study and patients will provide written consents. All patients consenting to participate will be included in the trial.

Yasmin, Calver and Placebo will be enclosed in sequentially numbered similar bottles which will be numbered using a computer generated random table. Women will be asked to choose a sealed envelope, each envelope will contain the number allocated to the jar and special instructions on how to use the medication. Yasmin will be taken once daily for 21 days starting from the 2nd day of menstruation, Calver and placebo will be taken continuously. Neither the patients nor the physician will be aware of the drug used. Patients will be categorized in 3 groups: group1 who will receive Yasmin cyclically for 3 months (Yasmin, schering, cairo, Egypt) and daily oral placebo, group 2 who will receive Calver continuously for 3 months (Calver, Marcryl/Vertex, Cairo Egypt) and oral placebo for 21 days, group 3 who will receive a daily placebo and a placebo similar to COC for 21 days and will act as a control group.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Premenstrual Syndrome
Intervention  ICMJE
  • Drug: Yasmin
    will be used every 21 days for three months by the patient
    Other Name: OCP
  • Dietary Supplement: Calver
    Calver will be given daily for 3 months
    Other Name: Calcium supplement
  • Drug: Placebo 1
    Patients will receive a daily placebo similar in size and structure to calvar.
  • Drug: Placebo 2
    Women will receive an oral placebo similar to COC for 21 days starting from the 3rd day of menstruation
Study Arms  ICMJE
  • Active Comparator: Yasmin
    Yasmin is an oral contraceptive pill containing (Disperinone 3mg+Ethinylestradiol 0.3mg) will be administered once daily orally by the woman from day 2 of the cycle for 21 days each month for 3 months in addition to a daily placebo.
    Interventions:
    • Drug: Yasmin
    • Drug: Placebo 1
  • Active Comparator: Calver
    Calver is a calcium supplement drug containing (ca 1000mg+vit D400 I.U) given to the woman continuously for 3 months in addition to placebo for 21 days
    Interventions:
    • Dietary Supplement: Calver
    • Drug: Placebo 2
  • Placebo Comparator: Placebo
    A daily oral placebo will be given to the patients daily for 3 months in addition to a placebo similar to COC for 21 days
    Interventions:
    • Drug: Placebo 1
    • Drug: Placebo 2
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2015)
210
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2014)
150
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients diagnosed by prospective dairy to have PMS
  • Consenting to be included in the study
  • Age 18-40 years

Exclusion Criteria:

  • Medical disorders as hypertension or diabetes.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02089620
Other Study ID Numbers  ICMJE Beni-Suef 1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
Study Sponsor  ICMJE Beni-Suef University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nesreen A Shehata, Lecturer Beni-Suef University
Study Chair: Abdelgany M Hassan, Lecturer Cairo University
PRS Account Beni-Suef University
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP