Premenstrual symptoms Urological and Genital Diseases Premenstrual symptoms
Conditions
Interventions
Subjects will be randomised to receive either 3 mg drospirenone/20 µg ethinyl estradiol in extended regimen (168 days of uninterrupted treatment) or drospirenone 3 mg/ethinyl estradiol 20 µg in standa
Sponsors
LIBBS Farmaceutica Ltd (Brazil)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Females of child bearing age (18 - 39 years) 2. At least three regular menstrual cycles lasting between 25 and 35 days, with 3 - 7 days of bleeding, without occurrence of intermenstrual bleeding and without amenorrhoea 3. Willingness to contraception and to meet the requirements of the study 4. Available to receive telephone calls 5. Competence to consent to participate in the study and sign the ICF 6. Education of at least four years or good ability to understand spoken and written information as testified by investigator 7. Complaint of at least one physical symptom and one emotional symptom in the premenstrual and/or menstrual period with intensity greater than or equal to two points according to scores of "Daily Symptom Report (DSR-17)" recorded by patient in the screening phase
Exclusion criteria
Exclusion criteria: 1. Users of hormonal contraceptives less than three months before the study. Exception will be considered to users of combined oral contraceptives without drospirenone in formulation, used in conventional 21/7 regimen. 2. Use of depot medroxyprogesterone acetate less than six months before the study 3. History of severe depression, bipolar disorder, psychosis, history of drug or alcohol abuse in the past two years 4. Treatment with antidepressants or anxiolytics 5. Any condition in category 2, 3 or 4 of the Medical Eligibility Criteria of the World Health Organization for contraceptive use, except for smoking** 6. Women smoking more than 15 cigarettes/day or smokers aged over 35 years 7. Use of drugs that interfere with the effectiveness of combined oral contraceptives 8. Suspected or confirmed pregnancy 9. Clinically significant changes in laboratory parameters requested in the screening visit 10. Participation in another trial less than three months before the study 11. Relationship to staff members of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of reduction in the total score of symptoms as recorded in the Daily Symptom Report (DSR-17) after treatment with 3 mg drospirenone/20 µg ethinyl estradiol in extended regime compared to standard regime. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bleeding pattern 2. Questionnaire for Quality of Life (Short WHOQOL) - Portuguese version, applied in visits C1, C3 and C4 3. Significant change in laboratory tests and clinical parameters | — |
Countries
Brazil
Outcome results
None listed