Clinical trial NCT02089620: Comparison Between Oral Contraceptive Pills and Calcium Supplements in Treatment of Premenstrual Syndrome
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Premenstrual Syndrome
Keywords: Premenstrual syndrome
Oral contraceptive pills
Calcium Supplements
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Improvement of premenstrual symptoms.
timeFrame: 3 months after starting treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Beni-Suef
country: Egypt
facility: Beni-Suef University
Study officials:
affiliation: Beni-Suef University
name: Nesreen A Shehata, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Abdelgany M Hassan, Lecturer
role: STUDY_CHAIR
References:
citation: Endicott J, Nee J, Harrison W. Daily Record of Severity of Problems (DRSP): reliability and validity. Arch Womens Ment Health. 2006 Jan;9(1):41-9. doi: 10.1007/s00737-005-0103-y. Epub 2005 Sep 20.
citation: Wyatt K, Dimmock P, Jones P, Obhrai M, O'Brien S. Efficacy of progesterone and progestogens in management of premenstrual syndrome: systematic review. BMJ. 2001 Oct 6;323(7316):776-80. doi: 10.1136/bmj.323.7316.776.
citation: Shehata NAA. RETRACTED: Calcium versus oral contraceptive pills containing drospirenone for the treatment of mild to moderate premenstrual syndrome: a double blind randomized placebo controlled trial. Eur J Obstet Gynecol Reprod Biol. 2016 Mar;198:100-104. doi: 10.1016/j.ejogrb.2016.01.015. Epub 2016 Jan 13.