Premenstrual syndrome, Premenstrual dysphoric disorder
Conditions
Interventions
None listed
Sponsors
Fukushima Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women 18 years of age or older at the time of registration. 2. Patients who visited an obstetrics and gynecology clinic for the treatment of dysmenorrhea and chose to be treated with E4/DRSP combination tablets. 3. Patients who reported some premenstrual symptoms and were diagnosed with moderate or severe PMS or PMDD using the Premenstrual Symptom Screening Tool (PSST). 4. Patients with regular menstrual cycles 5. Patients who provided written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients who have used oral contraceptives or hormonal agents containing progestins for the treatment of dysmenorrhea within 3 months prior to study entry. 2. Patients with any of the contraindications for use of E4/DRSP combination products. 3. Patients already being treated for PMS/PMDD 4. Patients who are pregnant, breastfeeding, or planning to become pregnant during the study. 5. Patients who were unable to continue attending the clinic and taking E4/DRSP until the fifth visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of total MDQ scores and sub-scores at the start of treatment with E4/DRSP combination treatment after 6 cycles. | — |
Countries
Japan
Contacts
Public ContactMariko Ogawa
Fukushima Medical University Fukushima Medical Center for Children and Women
Outcome results
None listed