Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

University of Southern California

Status: Completed

Conditions: Oral Contraceptive

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00972439

HS-07-00269

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 progestin (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 progestin; this research will examine that in detail.

Enrollment: 33 patients

Sex: Female

Ages: 18 to 34 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Age 18-34.
2. Premenopausal.
3. Currently taking or want to start oral contraceptives for contraception
4. Non-smoker.
5. Competent to give informed consent (as judged by the investigator).
6. Provided written informed consent.
7. Willingness to refrain from smoking and consumption of grapefruit or grapefruit juice during the study (grapefruit interferes with metabolism of exogenously administered OCs).

Exclusion Criteria:1.

1. Abnormal breast examination.
2. History or current therapeutic or prophylactic use of anticoagulants.
3. Known bleeding disorder or history of unexplained bleeding or bruising.
4. History of breast cancer or previous diagnostic breast biopsy.
5. Known allergy to local anesthetic.
6. Currently pregnant or pregnant within the previous 6 months.
7. Having any standard contra-indication to being prescribed OCs.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 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 Fe®

Active Comparator group

Description:

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

Treatment:

Drug: Oral Contraceptive: Ovcon Fe®