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Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation


N/A
18 Years
34 Years
Not Enrolling
Female
Oral Contraceptive

Thank you

Trial Information

Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation


Inclusion Criteria:



1. Age 18-34.

2. Premenopausal.

3. Currently taking or want to start oral contraceptives for contraception

4. Non-smoker.

5. Competent to give informed consent (as judged by the investigator).

6. Provided written informed consent.

7. Willingness to refrain from smoking and consumption of grapefruit or grapefruit juice
during the study (grapefruit interferes with metabolism of exogenously administered
OCs).

Exclusion Criteria:1.

1. Abnormal breast examination.

2. History or current therapeutic or prophylactic use of anticoagulants.

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

4. History of breast cancer or previous diagnostic breast biopsy.

5. Known allergy to local anesthetic.

6. Currently pregnant or pregnant within the previous 6 months.

7. Having any standard contra-indication to being prescribed OCs.

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 two oral contraceptive dose groups.

Safety Issue:

No

Principal Investigator

DeShawn Taylor, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Institutional Review Board

Study ID:

HS-07-00269

NCT ID:

NCT00972439

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Oral Contraceptive
  • Oral Contraceptives
  • Breast Tissue

Name

Location

Los Angeles County Hospital Los Angelses, California  90033