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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Beni-Suef University
Sponsor:
Information provided by (Responsible Party):
Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
ClinicalTrials.gov Identifier:
NCT02089620
First received: March 2, 2014
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Premenstrual Syndrome
Drug: Yasmin
Dietary Supplement: Calver
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Oral Contraceptive Pills Containing Disperinone and Calcium Supplements in Therapeutic Management of Premenstrual Syndrome

Resource links provided by NLM:


Further study details as provided by Beni-Suef University:

Primary Outcome Measures:
  • Improvement of premenstrual symptoms. [ Time Frame: 3 months after starting treatment. ] [ Designated as safety issue: No ]
    Improvement of symptoms will be assessed by comparing the pre-treatment recorded DRSP with that recorded 3 months after starting treatment.


Estimated Enrollment: 150
Study Start Date: May 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Yasmin
will be used every 21 days for three months by the patient
Other Name: OCP
Active Comparator: Calver
Calver is a calcium supplement drug containing (ca 1000mg+vit D400 I.U) given to the woman continuously for 3 months
Dietary Supplement: Calver
Calver will be given daily for 3 months
Other Name: Calcium supplement
Placebo Comparator: Placebo
Placebo will be given to the patients daily for 3 months
Drug: Placebo
Patients will receive a placebo daily for 3 months.

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 similar jars 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), group 2 who will receive Calver continuously for 3 months (Calver, Marcryl/Vertex, Cairo Egypt), group 3 who will receive placebo continuously for 3 months and will act as a control group.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02089620

Contacts
Contact: Nesreen A Shehata, Lecturer 00201227866337 nesoomar@yahoo.com

Locations
Egypt
Beni-Suef University Recruiting
Beni-Suef, Egypt
Principal Investigator: Nesreen A Shehata, Lecturer         
Sub-Investigator: Abdelgany M Hassan, Lecturer         
Sponsors and Collaborators
Beni-Suef University
Investigators
Principal Investigator: Nesreen A Shehata, Lecturer Beni-Suef University
Study Chair: Abdelgany M Hassan, Lecturer Cairo University
  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     History of Changes
Other Study ID Numbers: Beni-Suef 1
Study First Received: March 2, 2014
Last Updated: May 19, 2014
Health Authority: Egypt: Ministry of Higher Education

Keywords provided by Beni-Suef University:
Premenstrual syndrome
Oral contraceptive pills
Calcium Supplements

Additional relevant MeSH terms:
Menstruation Disturbances
Syndrome
Premenstrual Syndrome
Disease
Pathologic Processes
Calcium, Dietary
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 18, 2014