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

• ClinicalTrials.gov Identifier: NCT02089620
• Recruitment Status: Completed
• First Posted: March 18, 2014
• Last Update Posted: August 11, 2015
• Sponsor: Beni-Suef University
• Information provided by (Responsible Party): Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

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
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: June 2015

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

• 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

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:

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. Epub 2005 Sep 20.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Retraction in: Eur J Obstet Gynecol Reprod Biol. 2019 Sep;240:387.

Retraction in: Eur J Obstet Gynecol Reprod Biol. 2019 Sep;240:387

• 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
• 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:

Drospirenone and ethinyl estradiol combination; Syndrome; Premenstrual Syndrome; Disease; Pathologic Processes; Menstruation Disturbances; Calcium, Dietary; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Calcium; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Reproductive Control Agents; Contraceptive Agents, Female