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ISRCTN
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ISRCTN59588862
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ClinicalTrials.gov identifier
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Public title
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Study of proliferation in the mammary epithelium of young women using combined oral contraceptives
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Scientific title
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Acronym
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EPEMAHO (Estudo da Proliferacao no Epitelio da Mama de usuarias de Anticoncepcional Hormonal Oral)
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Serial number at source
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685/000
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Study hypothesis
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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.
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Ethics approval
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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.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Brazil
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Disease/condition/study domain
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Fibroadenoma
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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23/11/2000
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Anticipated end date
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15/12/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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82 patients
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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1. Federal University of Sao Paulo and Health Ministry of Brazil (Brazil)
2. The National Commission of Ethics in Research (Comissao Nacional de Etica em Pesquisas [CONEP]) (Brazil) (registration number: 685/000)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18657146
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Contact name
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Dr
Maria Alicia
Navarrete
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Address
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Rua Jose Maria Lisboa
1036 apto 111
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City/town
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Sao Paulo
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Zip/Postcode
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01423000
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Country
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Brazil
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Tel
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+55 (11) 3088 0096
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Email
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chile@stanford.edu
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Sponsor
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Federal university of Sao Paulo (Universidade Federal de Sao Paulo) (Brazil)
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Address
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Escola Paulista de Medicina
Rua Botucatu
740 - Vila Clementino
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City/town
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Sao Paulo
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Zip/Postcode
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01454-010
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Country
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Brazil
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Tel
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+55 (11) 570 3321
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Fax
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+55 (11) 570 8715
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Email
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dgnarvaiza@intertim.com.br
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Sponsor website:
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http://www.unifesp.br/
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Date applied
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11/11/2006
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Last edited
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01/10/2008
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Date ISRCTN assigned
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14/12/2006
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