Study of proliferation in the mammary epithelium of young women using combined oral contraceptives
| ISRCTN | ISRCTN59588862 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59588862 |
| Secondary identifying numbers | 685/000 |
- Submission date
- 11/11/2006
- Registration date
- 14/12/2006
- Last edited
- 01/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Maria Alicia Navarrete
Scientific
Scientific
Rua Jose Maria Lisboa
1036 apto 111
Sao Paulo
01423000
Brazil
| Phone | +55 (11) 3088 0096 |
|---|---|
| chile@stanford.edu |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | EPEMAHO (Estudo da Proliferacao no Epitelio da Mama de usuarias de Anticoncepcional Hormonal Oral) |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ethinyl estradiol and levonorgestrel |
| Primary outcome measure | 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 study start date | 23/11/2000 |
| Completion date | 15/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 82 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 23/11/2000 |
| Date of final enrolment | 15/12/2004 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua Jose Maria Lisboa
Sao Paulo
01423000
Brazil
01423000
Brazil
Sponsor information
Federal university of Sao Paulo (Universidade Federal de Sao Paulo) (Brazil)
University/education
University/education
Escola Paulista de Medicina
Rua Botucatu
740 - Vila Clementino
Sao Paulo
01454-010
Brazil
| Phone | +55 (11) 570 3321 |
|---|---|
| dgnarvaiza@intertim.com.br | |
| Website | http://www.unifesp.br/ |
"ROR" |
https://ror.org/02k5swt12 |
Funders
Funder type
University/education
Federal University of Sao Paulo and Health Ministry of Brazil (Brazil)
No information available
The National Commission of Ethics in Research (Comissao Nacional de Etica em Pesquisas [CONEP]) (Brazil) (registration number: 685/000)
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 | 01/09/2008 | Yes | No |
