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