Contact information
Type
Scientific
Primary contact
Dr Maria Alicia Navarrete
ORCID ID
Contact details
Rua Jose Maria Lisboa
1036 apto 111
Sao Paulo
01423000
Brazil
+55 (11) 3088 0096
chile@stanford.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
685/000
Study information
Scientific title
Acronym
EPEMAHO (Estudo da Proliferacao no Epitelio da Mama de usuarias de Anticoncepcional Hormonal Oral)
Study hypothesis
Combined Oral Contraceptives (COC) affect the proliferation rate of mammary epithelium in young women (below 36 years of age) to a greater degree than older women.
Ethics approval
This study, at the time of registration, received appropriate ethics committee approval from the Health Ministry of Brazil and the National Committee of Research Ethics on December 12, 2000.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Fibroadenoma
Intervention
Goal:
To determine the impact of one cycle of a combined oral contraceptive on breast homeostasis, we evaluated the Proliferation Index (PI), determined by the expression of KI-67, in normal human mammary epithelial cells and correlated it with cellular proliferation in spontaneous menstrual cycles during the same period.
Methods:
Normal breast tissue samples were obtained from 82 patients who were randomised in two groups:
Group A - Forty two women received one cycle of a Combined Oral Contraceptive (COC) (30 µg ethinyl estradiol and 150 µg levonorgestrel) administrated daily for 21 days, beginning on the first day of the menstrual cycle.
Group B - Forty patients experienced a natural menstrual cycle. No placebo was given.
Excision of the fibroadenoma then took place.
Menstrual cycle phase characterisation was based on the date of the last period and subsequent menses, and on progesterone serum levels obtained just before the time of biopsy.
Intervention type
Drug
Phase
Not Specified
Drug names
Ethinyl estradiol and levonorgestrel
Primary outcome measures
Successful excision of fibroadenoma; the histologically normal tissue (at least 1 cm away from the FA) was studied in women with COC and with natural cycles during the first, second, third and fourth week of the menstrual cycle.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
23/11/2000
Overall trial end date
15/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Females between 14 to 36 years of age
2. Undergoing excision of Fibroadenomas (FA) (a condition thought not to be associated with an increase risk of cancer) at the Department of Gynecology, Mastology Division: Benign mammary diseases, Federal University of São Paulo, Paulista Medical School
3. Signed an informed consent before enrolment in the study
4. Regular menstrual cycles (intervals of 28 ± two days) in the previous six months
5. A known date of the last menstrual period
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
82 patients
Participant exclusion criteria
1. Use of hormone therapy in the previous 12 months
2. Pregnancy
3. Breast feeding during the previous 12 months
4. Any endocrine disorder
5. Taking any medication at the time that tissue for the study was obtained
Recruitment start date
23/11/2000
Recruitment end date
15/12/2004
Locations
Countries of recruitment
Brazil
Trial participating centre
Rua Jose Maria Lisboa
Sao Paulo
01423000
Brazil
Sponsor information
Organisation
Federal university of Sao Paulo (Universidade Federal de Sao Paulo) (Brazil)
Sponsor details
Escola Paulista de Medicina
Rua Botucatu
740 - Vila Clementino
Sao Paulo
01454-010
Brazil
+55 (11) 570 3321
dgnarvaiza@intertim.com.br
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Federal University of Sao Paulo and Health Ministry of Brazil (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The National Commission of Ethics in Research (Comissao Nacional de Etica em Pesquisas [CONEP]) (Brazil) (registration number: 685/000)
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18657146
Publication citations
-
Results
Garcia y Narvaiza D, Navarrete MA, Falzoni R, Maier CM, Nazário AC, Effect of combined oral contraceptives on breast epithelial proliferation in young women., Breast J, 14, 5, 450-455, doi: 10.1111/j.1524-4741.2008.00621.x.