Condition category
Urological and Genital Diseases
Date applied
26/08/2010
Date assigned
05/10/2010
Last edited
05/10/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Achilles Cruz

ORCID ID

Contact details

250 Josef Kryss
São Paulo
01140-050
Brazil

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 measures

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

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

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

http://www.libbs.com.br

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes