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

Sponsor
Beni-Suef University (Other)
Overall Status
Completed
CT.gov ID
NCT02089620
Collaborator
(none)
210
Enrollment
1
Location
3
Arms
13
Duration (Months)
16.1
Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Drug: Yasmin
  • Dietary Supplement: Calver
  • Drug: Placebo 1
  • Drug: Placebo 2
 Phase 3

Detailed Description

Premenstrual syndrome (PMS) is deļ¬ned 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 Design

Study Type:
Interventional
Actual Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Calcium Supplements Versus Oral Contraceptive Pills Containing Drospirenone in Treating Mild to Moderate Premenstrual Syndrome: A Double Blind Randomized Placebo Controlled Trial
Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Yasmin
will be used every 21 days for three months by the patient
Other Names:
  • OCP

    • Drug: Placebo 1
    Patients will receive a daily placebo similar in size and structure to calvar.
    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

    Dietary Supplement: Calver
    Calver will be given daily for 3 months
    Other Names:
  • Calcium supplement

    • Drug: Placebo 2
    Women will receive an oral placebo similar to COC for 21 days starting from the 3rd day of menstruation
    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

    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

    Outcome Measures

    Primary Outcome Measures

    1. Improvement of premenstrual symptoms. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beni-Suef University Beni-Suef Egypt

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

    • Principal Investigator: Nesreen A Shehata, Lecturer, Beni-Suef University
    • Study Chair: Abdelgany M Hassan, Lecturer, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Nesreen Abdel Fattah Abdullah Shehata, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT02089620
    Other Study ID Numbers:
    • Beni-Suef 1
    First Posted:
    Mar 18, 2014
    Last Update Posted:
    Aug 11, 2015
    Last Verified:
    Aug 1, 2015
    Keywords provided by Nesreen Abdel Fattah Abdullah Shehata, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University, Beni-Suef University
    Premenstrual syndrome
    Oral contraceptive pills
    Calcium Supplements
    Additional relevant MeSH terms:
    Syndrome
    Premenstrual Syndrome

    Study Results

    No Results Posted as of Aug 11, 2015