Comparison Between Oral Contraceptive Pills and Calcium Supplements in Treatment of Premenstrual Syndrome (PMS)
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 .
Dietary Supplement: Calver
|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|
- 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.
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
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.
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
Patients will receive a placebo daily for 3 months.
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 .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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02089620
|Contact: Nesreen A Shehata, Lecturerfirstname.lastname@example.org|
|Principal Investigator: Nesreen A Shehata, Lecturer|
|Sub-Investigator: Abdelgany M Hassan, Lecturer|
|Principal Investigator:||Nesreen A Shehata, Lecturer||Beni-Suef University|
|Study Chair:||Abdelgany M Hassan, Lecturer||Cairo University|