Condition category
Cancer
Date applied
11/11/2006
Date assigned
14/12/2006
Last edited
01/10/2008
Prospective/Retrospective
Retrospectively 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 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

http://www.unifesp.br/

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

  1. 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.

Additional files

Editorial Notes