Comparison Between Oral Contraceptive Pills and Calcium Supplements in Treatment of Premenstrual Syndrome
- Conditions
- Premenstrual Syndrome
- Interventions
- Registration Number
- NCT02089620
- Lead Sponsor
- Beni-Suef University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 210
- Patients diagnosed by prospective dairy to have PMS
- Consenting to be included in the study
- Age 18-40 years
- Medical disorders as hypertension or diabetes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Calver Placebo 2 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 Placebo Placebo 1 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 Placebo Placebo 2 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 Calver 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 Yasmin Placebo 1 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. Yasmin 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Beni-Suef University
🇪🇬Beni-Suef, Egypt