ISRCTN57661673CompletedPhase 3
A randomised multicentre parallel-group, comparative, prospective, open label study to assess the effect of extended regimen versus standard regimen of the oral contraceptive 3 mg drospirenone/20 µg ethinyl estradiol in premenstrual and/or menstrual symptoms
IBBS Farmaceutica Ltd (Brazil)0 sites348 target enrollmentStarted: October 5, 2010Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 348
Study Overview
Brief Summary
2020 results in https://pubmed.ncbi.nlm.nih.gov/32280282 (added 15/04/2020)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
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
- •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
Investigators
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