Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LB0901
Study information
Scientific title
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
Acronym
Study hypothesis
This study aims to show the non-inferiority of the extended regimen compared to standard regimen of the oral contraceptive drospirenone/ethinyl estradiol in the treatment of premenstrual and/or menstrual symptoms.
Ethics approval
Ethics Committee of the Faculty of Medicine Jundiai approved on the 5th August 2010 (ref: 176/10)
Study design
Randomised double-arm multicentre comparative prospective parallel groups open label trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Premenstrual symptoms
Intervention
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 standard regimen (6 cycles of 24 days of treatment followed by 4-day tablet free interval).
Subjects will record the scores of symptoms and patterns of bleeding in a daily diary. Questionnaire for Quality of Life (Short WHOQOL) will be applied in visits C1 (after 1 month of treatment), C2 (after 3 months of treatment) and C4 (after 6 months of treatment).
Intervention type
Drug
Phase
Phase III
Drug names
Drospirenone, ethinyl estradiol
Primary outcome measure
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 outcome measures
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
Overall trial start date
10/01/2011
Overall trial end date
28/02/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
368 subjects randomised
Total final enrolment
348
Participant 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
Recruitment start date
10/01/2011
Recruitment end date
28/02/2012
Locations
Countries of recruitment
Brazil
Trial participating centre
250 Josef Kryss
São Paulo
01140-050
Brazil
Sponsor information
Organisation
LIBBS Farmaceutica Ltd (Brazil)
Sponsor details
250 Josef Kryss
São Paulo
01140-050
Brazil
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
LIBBS Farmaceutica Ltd (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2020 results in https://pubmed.ncbi.nlm.nih.gov/32280282 (added 15/04/2020)