ISRCTN57661673
Completed
Phase 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 enrollmentOctober 5, 2010
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- IBBS Farmaceutica Ltd (Brazil)
- Enrollment
- 348
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
2020 results in https://pubmed.ncbi.nlm.nih.gov/32280282 (added 15/04/2020)
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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