Comparison of the effect of dydrogesterone and calcium plus vitamin D on the severity of premenstrual syndrome
- Conditions
- Severity of premenstrual syndrome.Pain and other conditions associated with female genital organs and menstrual cycle
- Registration Number
- IRCT138711201548N2
- Lead Sponsor
- Deputy for Research of Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 180
(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.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of premenstrual syndrome. Timepoint: one month. Method of measurement: Daily symptom rating questionnaire.
- Secondary Outcome Measures
Name Time Method Decrease in the severity of premenstrula syndrome. Timepoint: one month. Method of measurement: questionnaire of daily symptom rating.