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Completed

NCT Number: NCT00972439

Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

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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Key information

Conditions

Oral Contraceptive

Age range

18 year–34 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Los Angeles County Hospital

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-34.
  • Premenopausal.
  • Currently taking or want to start oral contraceptives for contraception
  • Non-smoker.
  • Competent to give informed consent (as judged by the investigator).
  • Provided written informed consent.
  • 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.
  • 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.
  • Currently pregnant or pregnant within the previous 6 months.
  • Having any standard contra-indication to being prescribed OCs.

Treatment and study plan

Oral Contraceptive: Ortho-Novum® 1/35

Drug

Oral Contraceptive: Ovcon Fe®

Drug

Primary outcomes

  1. Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups

    Time frame: 32 weeks

    Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 7, 2009
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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