We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT02089620
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):

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
Premenstrual Syndrome Drug: Yasmin Dietary Supplement: Calver Drug: Placebo 1 Drug: Placebo 2 Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
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 2014
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: 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. [ 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.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

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): NCT02089620


Locations
Egypt
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
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015

Keywords provided by Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University:
Premenstrual syndrome
Oral contraceptive pills
Calcium Supplements

Additional relevant MeSH terms:
Syndrome
Premenstrual Syndrome
Disease
Pathologic Processes
Menstruation Disturbances
Calcium, Dietary
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Drospirenone and ethinyl estradiol combination
Bone Density Conservation Agents
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female