Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation

Study Overview
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Brief Summary
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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.

Official Title
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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?

Conditions
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Oral Contraceptive

Intervention / Treatment
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* Drug: Oral Contraceptive: Ortho-Novum® 1/35
* Drug: Oral Contraceptive: Ovcon® 35
* Drug: Oral Contraceptive: Microgestin Fe® 1/20


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-35 BMI <30 kg/m2 Premenopausal with regular cycles or currently taking an OC Not currently or recently pregnant or nursing (within previous 6 months) Non-smoker No use of antibiotics within the prior 4 weeks Competent to provide written informed consent (as judged by study team) Willing to adhere to the OC regimen Willingness to refrain from the use of aspirin or NSAIDS 10 days pior to the biopsy appointment and one week following the biopsy procedure 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: Diabetes Abnormal breast examination Abnormal PT/INR and/or CBC with platelets test results (as determined by one of the study physicians) History or current therapeutic or prophylactic use of anticoagulants Known bleeding disorder or history of unexplained bleeding or bruising History of breast cancer or previous diagnostic breast biopsy Known allergy to local anesthetic

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ortho-Novum® 1/35<br>Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. | Drug: Oral Contraceptive: Ortho-Novum® 1/35<br>* Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily.<br>|
| Active Comparator: Ovcon® 35<br>Ovcon® 35 is an oral contraceptive that contains less progestin. | Drug: Oral Contraceptive: Ovcon® 35<br>* Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.<br>|
| Active Comparator: Microgestin Fe® 1/20<br>is an oral contraceptive that contains less estrogen. | Drug: Oral Contraceptive: Microgestin Fe® 1/20<br>* Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure breast cell proliferation levels between the three oral contraceptive dose groups. |  | 2 years |