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OpenTrials
Completed

NCT Number: NCT02089620

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

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 .

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Beni-Suef University

Banī Suwayf, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yasmin

Drug

will be used every 21 days for three months by the patient

Other names: OCP

Calver

Dietary Supplement

Calver will be given daily for 3 months

Other names: Calcium supplement

Placebo 1

Drug

Patients will receive a daily placebo similar in size and structure to calvar.

Placebo 2

Drug

Women will receive an oral placebo similar to COC for 21 days starting from the 3rd day of menstruation

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Acronym: PMS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2014
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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