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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Calcium Supplements Versus Oral Contraceptive Pills Containing Drospirenone in Treating Mild to Moderate Premenstrual Syndrome: A Double Blind Randomized Placebo Controlled Trial

Conditions
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Premenstrual Syndrome

Intervention / Treatment
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* Drug: Yasmin
* Dietary Supplement: Calver
* Drug: Placebo 1
* Drug: Placebo 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Yasmin<br>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<br>* will be used every 21 days for three months by the patient<br>* Other names: OCP;Drug: Placebo 1<br>* Patients will receive a daily placebo similar in size and structure to calvar.<br>|
| Active Comparator: Calver<br>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<br>* Calver will be given daily for 3 months<br>* Other names: Calcium supplement;Drug: Placebo 2<br>* Women will receive an oral placebo similar to COC for 21 days starting from the 3rd day of menstruation<br>|
| Placebo Comparator: Placebo<br>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<br>* Patients will receive a daily placebo similar in size and structure to calvar.<br>Drug: Placebo 2<br>* Women will receive an oral placebo similar to COC for 21 days starting from the 3rd day of menstruation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of premenstrual symptoms. | Improvement of symptoms will be assessed by comparing the pre-treatment recorded DRSP with that recorded 3 months after starting treatment. | 3 months after starting treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premenstrual syndrome, Oral contraceptive pills, Calcium Supplements