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OpenTrials
Completed

NCT Number: NCT01318005

Oral Contraceptive (OC) Estrogen 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 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.

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Key information

Conditions

Oral Contraceptive

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

USC University 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 18-35
  • 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

Treatment and study plan

Oral Contraceptive: Ortho-Novum® 1/35

Drug

Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily.

Oral Contraceptive: Ovcon® 35

Drug

Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.

Oral Contraceptive: Microgestin Fe® 1/20

Drug

Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily.

Primary outcomes

  1. Breast Cell Proliferation Levels Between the Three Oral Contraceptive Groups

    Time frame: Up to 3 months.

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

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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?

Acronym: OCP2

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Mar 18, 2011
Registry last updated
Feb 17, 2026

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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