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-Novum® 1/35 (Drug); Oral Contraceptive: Ovcon Fe® (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
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