Severity of premenstrual syndrome. Pain and other conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
Intervention 1: Dydrogesterone,twice daily from the 15th to the 24th day of the menstrual cycle. Intervention 2: Calcium D, twice daily from the 15th to the 24th day of the cycle. Intervention 3: Plac
Treatment - Drugs
Placebo
Dydrogesterone,twice daily from the 15th to the 24th day of the menstrual cycle
Calcium D, twice daily from the 15th to the 24th day of the cycle
Placebo: twice daily from the 15th to the 24th day of the cycle
Sponsors
Deputy for Research of Shiraz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 26 Years
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of premenstrual syndrome. Timepoint: one month. Method of measurement: Daily symptom rating questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Decrease in the severity of premenstrula syndrome. Timepoint: one month. Method of measurement: questionnaire of daily symptom rating. | — |
Countries
Iran (Islamic Republic of)
Outcome results
None listed