NCT02089620

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

1.1 years

First QC Date

March 2, 2014

Last Update Submit

August 7, 2015

Conditions

Premenstrual Syndrome

Keywords

Premenstrual syndromeOral contraceptive pillsCalcium Supplements

Outcome Measures

Primary Outcomes (1)

  • Improvement of premenstrual symptoms.

    Improvement of symptoms will be assessed by comparing the pre-treatment recorded DRSP with that recorded 3 months after starting treatment.

    3 months after starting treatment.

Study Arms (3)

Yasmin

ACTIVE COMPARATOR

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: YasminDrug: Placebo 1

Calver

ACTIVE COMPARATOR

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: CalverDrug: Placebo 2

Placebo

PLACEBO COMPARATOR

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 1Drug: Placebo 2

Interventions

YasminDRUG

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

Also known as: OCP
Yasmin
CalverDIETARY_SUPPLEMENT

Calver will be given daily for 3 months

Also known as: Calcium supplement
Calver
Placebo 1DRUG

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

PlaceboYasmin
Placebo 2DRUG

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

CalverPlacebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed by prospective dairy to have PMS
  • Consenting to be included in the study
  • Age 18-40 years

You may not qualify if:

  • Medical disorders as hypertension or diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef University

Banī Suwayf, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 16172836BACKGROUND

  • 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.

    PMID: 11588078BACKGROUND

  • 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.

    PMID: 26808666DERIVED

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nesreen A Shehata, Lecturer

    Beni-Suef University

    PRINCIPAL INVESTIGATOR

  • Abdelgany M Hassan, Lecturer

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

Study Record Dates

First Submitted

March 2, 2014

First Posted

March 18, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations

EG(1)