Study of proliferation in the mammary epithelium of young women using combined oral contraceptives
Completed
- Conditions
- FibroadenomaCancerBreast cancer
- Registration Number
- ISRCTN59588862
- Lead Sponsor
- Federal university of Sao Paulo (Universidade Federal de Sao Paulo) (Brazil)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 82
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method ot provided at time of registration