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Oral Contraceptive (OC) Estrogen 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® 35 (Drug); Oral Contraceptive: Microgestin Fe® 1/20 (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Southern California

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

Overall contact:
Anna H Wu, Ph.D., Phone: 323 865 0484, Email: annawu@usc.edu


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 estrogen (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 estrogen; this research will examine that in detail. This research will also test whether the results found in HS-07-00269 can be confirmed.

Clinical Details

Official title: 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?

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 three oral contraceptive dose groups.


Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.


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

Locations and Contacts

Anna H Wu, Ph.D., Phone: 323 865 0484, Email: annawu@usc.edu

USC University Hospital, Los Angeles, California 90033, United States; Recruiting
Heather MacDonald, M.D., Principal Investigator
Additional Information

Starting date: January 2011
Last updated: September 9, 2014

Page last updated: August 23, 2015

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