Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

NCT00972439 | Completed Results

• 1 other identifier: HS-07-00269
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Contraceptive

Keywords

Oral Contraceptives; Breast Tissue

Outcome Measures

Primary Outcomes (1)

• Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups

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

  32 weeks

Study Arms (2)

Ortho-Novum® 1/35

ACTIVE COMPARATOR

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

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

Ovcon Fe®

ACTIVE COMPARATOR

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

Drug: Oral Contraceptive: Ovcon Fe®

Interventions

Oral Contraceptive: Ortho-Novum® 1/35 DRUG

Ortho-Novum® 1/35

Oral Contraceptive: Ovcon Fe® DRUG

Ovcon Fe®

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• United States Department of Defense: collaborator

Study Sites (1)

Los Angeles County Hospital

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• Hovanessian-Larsen L, Taylor D, Hawes D, Spicer DV, Press MF, Wu AH, Pike MC, Pearce CL. Lowering oral contraceptive norethindrone dose increases estrogen and progesterone receptor levels with no reduction in proliferation of breast epithelium: a randomized trial. Contraception. 2012 Sep;86(3):238-43. doi: 10.1016/j.contraception.2011.12.015. Epub 2012 Feb 9.

  PMID: 22325110 DERIVED

Results Point of Contact

• Title: Celeste Pearce, Ph.D.
• Organization: USC/Norris Comprehensive Cancer Center

cpearce@usc.edu

323 865 0437

Study Officials

• DeShawn Taylor, M.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 7, 2009
• Study Start: August 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 23, 2018
• Results First Posted: February 23, 2018

Record last verified: 2017-12

Locations

US (1)