Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation (OCP2)

University of Southern California

Status: Unknown

Conditions: Oral Contraceptive

Treatments: Drug: Oral Contraceptive: Ortho-Novum® 1/35; Drug: Oral Contraceptive: Microgestin Fe® 1/20; Drug: Oral Contraceptive: Ovcon® 35

Study type: Interventional

Funder types: Other

Identifiers

NCT01318005

HS-10-00455

Details and patient eligibility

About

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.

Enrollment: 85 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 3 patient groups

Ortho-Novum® 1/35

Active Comparator group

Description:

Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.

Treatment:

Drug: Oral Contraceptive: Ortho-Novum® 1/35

Ovcon® 35

Active Comparator group

Description:

Ovcon® 35 is an oral contraceptive that contains less progestin.

Treatment:

Drug: Oral Contraceptive: Ovcon® 35

Microgestin Fe® 1/20

Active Comparator group

Description:

is an oral contraceptive that contains less estrogen.

Treatment:

Drug: Oral Contraceptive: Microgestin Fe® 1/20