Objective: To compare the effects of dydrogesterone and Calcium plus Vitamin D on women with severe premenstrual syndrome (PMS). Method: In this randomized, double-blind, placebo-controlled study, 180 Shiraz University students with PMS recruited. They completed questionnaires to record their symptoms for 2 menstrual cycles. Then, the students were randomly assigned to take one of interventions including: 5 mg of dydrogesterone, 500 mg of calcium plus 200 mg of vitamin D, or a placebo twice daily from the 15th to the 24th day of the cycle for 2 more cycles. They completed the same questionnaires during the intervention cycles.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711201548N2
Registration date:2009-09-09, 1388/06/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-09-09, 1388/06/18
Registrant information
Name
Khadijeh Abdali
Name of organization / entity
Fatemeh college of nursing and midwifery, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4255
Email address
abdalikh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research of Shiraz University of Medical Sciences
Expected recruitment start date
2008-02-03, 1386/11/14
Expected recruitment end date
2009-03-04, 1387/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of treatment with dydrogesterone or calcium plus vitamin D on the severity of premenstrual syndrome
Public title
Comparison of the effect of dydrogesterone and calcium plus vitamin D on the severity of premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (1) having regular menstrual cycles (3–8 days of menstruation between intervals of 22–35 days); (2) not taking medications such as hormonal contraceptives, antipsychotics, or vitamins; (3) not having contraindications to taking dydrogesterone or supplements containing calcium or vitamin D; (4) meeting the American College of Obstetrics and Gynecology and American Psychiatric Association standard diagnostic criteria for PMS (5 or more symptoms present for most of the time during the 7–10 days prior to menstruation; symptoms beginning to remit a few days after the onset of the follicular phase and absent in the week following the menses; and at least 1 symptom in the psychotic domain); (5) diagnostic criteria confirmed by prospective daily symptom ratings during at least 2 consecutive cycles; (6) symptoms markedly interfering with work or school activities and relationships; (7) symptoms not merely an exacerbation of another condition such as epilepsy or a major depressive disorder, panic disorder, or personality disorder; and (8) not using daily foods containing a great deal of calcium and/or vitamin D.
Age
From 18 years old to 26 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand St.
City
Shiraz
Postal code
Approval date
2008-02-03, 1386/11/14
Ethics committee reference number
86-3812
Health conditions studied
1
Description of health condition studied
Severity of premenstrual syndrome
ICD-10 code
N94
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
Severity of premenstrual syndrome
Timepoint
one month
Method of measurement
Daily symptom rating questionnaire
Secondary outcomes
1
Description
decrease in the severity of premenstrula syndrome
Timepoint
one month
Method of measurement
questionnaire of daily symptom rating
Intervention groups
1
Description
Dydrogesterone,twice daily from the 15th to the 24th day of the menstrual cycle
Category
Treatment - Drugs
2
Description
Calcium D, twice daily from the 15th to the 24th day of the cycle
Category
Treatment - Drugs
3
Description
Placebo: twice daily from the 15th to the 24th day of the cycle
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University
Full name of responsible person
Street address
Eram sq.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for Research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hosein Dabbagh Manesh
Street address
Zand st.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh College of Nursing and Midwifery, Shiraz
Full name of responsible person
Khadijeh Abdali
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Namazi Sq.
City
Shiraz
Postal code
Phone
+98 71164742528
Fax
Email
abdalikh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Khadijeh Abdali
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)