Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 4/2/2016 |
| Start Date: | January 2011 |
| End Date: | December 2016 |
| Contact: | Anna H Wu, Ph.D. |
| Email: | annawu@usc.edu |
| Phone: | 323 865 0484 |
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?
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.
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.
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
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