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Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

Information source: University of Southern California
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Oral Contraceptive

Intervention: Oral Contraceptive: Ortho-NovumĀ® 1/35 (Drug); Oral Contraceptive: Ovcon FeĀ® (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Southern California

Official(s) and/or principal investigator(s):
DeShawn Taylor, M.D., Principal Investigator, Affiliation: University of Southern California

Summary

The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of progestin (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of progestin; this research will examine that in detail.

Clinical Details

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

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

Primary outcome: To measure breast cell proliferation levels between the two oral contraceptive dose groups.

Eligibility

Minimum age: 18 Years. Maximum age: 34 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Los Angeles County Hospital, Los Angelses, California 90033, United States
Additional Information

Starting date: August 2007
Last updated: September 4, 2009

Page last updated: August 23, 2015

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