Skip to content

Study of proliferation in the mammary epithelium of young women using combined oral contraceptives

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN59588862
Enrollment
82
Registered
2006-12-14
Start date
2000-11-23
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibroadenoma Cancer Breast cancer

Interventions

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 ma

Sponsors

Federal university of Sao Paulo (Universidade Federal de Sao Paulo) (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not provided at time of registration

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026