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The Effects of Dose and Formulation of Oral Contraceptives (OCs) on Breast-Cell Proliferation: Can the Chemopreventive Effects of OCs on Endometrial and Ovarian Cancer be Extended to Breast Cancer?


N/A
18 Years
35 Years
Open (Enrolling)
Female
Oral Contraceptive

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Trial Information

The Effects of Dose and Formulation of Oral Contraceptives (OCs) on Breast-Cell Proliferation: Can the Chemopreventive Effects of OCs on Endometrial and Ovarian Cancer be Extended to Breast Cancer?


Inclusion Criteria:



1. Age 18-35

2. BMI <30 kg/m2

3. Premenopausal with regular cycles or currently taking an OC

4. Not currently or recently pregnant or nursing (within previous 6 months)

5. Non-smoker

6. No use of antibiotics within the prior 4 weeks

7. Competent to provide written informed consent (as judged by study team)

8. Willing to adhere to the OC regimen

9. Willingness to refrain from the use of aspirin or NSAIDS 10 days pior to the biopsy
appointment and one week following the biopsy procedure

10. Willing and able to refrain from use of fish oils 10 days prior to the biopsy
appointment and one week following the biopsy procedure

Exclusion Criteria:

1. Diabetes

2. Abnormal breast examination

3. Abnormal PT/INR and/or CBC with platelets test results (as determined by one of the
study physicians)

4. History or current therapeutic or prophylactic use of anticoagulants

5. Known bleeding disorder or history of unexplained bleeding or bruising

6. History of breast cancer or previous diagnostic breast biopsy

7. Known allergy to local anesthetic

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

To measure breast cell proliferation levels between the three oral contraceptive dose groups.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Heather MacDonald, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Institutional Review Board

Study ID:

HS-10-00455

NCT ID:

NCT01318005

Start Date:

January 2011

Completion Date:

December 2014

Related Keywords:

  • Oral Contraceptive

Name

Location

USC University HospitalLos Angeles, California  90033