Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-11-30

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 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.

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Detailed Description

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Conditions

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Oral Contraceptive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ortho-Novum® 1/35

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

Group Type ACTIVE_COMPARATOR

Oral Contraceptive: Ortho-Novum® 1/35

Intervention Type DRUG

Ovcon Fe®

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

Group Type ACTIVE_COMPARATOR

Oral Contraceptive: Ovcon Fe®

Intervention Type DRUG

Interventions

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Oral Contraceptive: Ortho-Novum® 1/35

Intervention Type DRUG

Oral Contraceptive: Ovcon Fe®

Intervention Type DRUG

Eligibility Criteria

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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. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes