Evaluation of the extended regimen versus standard regimen of oral contraceptive in premenstrual and/or menstrual symptoms

ISRCTN	ISRCTN57661673
DOI	https://doi.org/10.1186/ISRCTN57661673
Secondary identifying numbers	LB0901

Submission date: 26/08/2010
Registration date: 05/10/2010
Last edited: 15/04/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Achilles Cruz
Scientific

250 Josef Kryss
São Paulo
01140-050
Brazil

Study information

Study design	Randomised double-arm multicentre comparative prospective parallel groups open label trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Ethics Committee of the Faculty of Medicine Jundiai approved on the 5th August 2010 (ref: 176/10)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	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 study start date	10/01/2011
Completion date	28/02/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	368 subjects randomised
Total final enrolment	348
Key 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
Key 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
Date of first enrolment	10/01/2011
Date of final enrolment	28/02/2012

Locations

Countries of recruitment

Brazil

Study participating centre

250 Josef Kryss

São Paulo
01140-050
Brazil

Sponsor information

LIBBS Farmaceutica Ltd (Brazil)
Industry

250 Josef Kryss
São Paulo
01140-050
Brazil

Website	http://www.libbs.com.br
"ROR"	https://ror.org/055kp8612

Funders

Funder type

Industry

LIBBS Farmaceutica Ltd (Brazil)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	30/03/2020	15/04/2020	Yes	No

Editorial Notes

15/04/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.