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Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

This study has been completed.
Sponsor:
Collaborator:
Department of Defense
Information provided by:
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00972439
First received: September 3, 2009
Last updated: September 4, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention
Oral Contraceptive
 Drug: Oral Contraceptive: Ortho-Novum® 1/35
Drug: Oral Contraceptive: Ovcon Fe®

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by USC/Norris Comprehensive Cancer Center:

Primary Outcome Measures:
  • To measure breast cell proliferation levels between the two oral contraceptive dose groups. [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2007
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ortho-Novum® 1/35
Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
 Drug: Oral Contraceptive: Ortho-Novum® 1/35
Active Comparator: Ovcon Fe®
Ovcon Fe® is an oral contraceptive that contains less progestin.
 Drug: Oral Contraceptive: Ovcon Fe®

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972439

Locations
United States, California
Los Angeles County Hospital
Los Angelses, California, United States, 90033
Sponsors and Collaborators
USC/Norris Comprehensive Cancer Center
Department of Defense
Investigators
Principal Investigator: DeShawn Taylor, M.D. University of Southern California
  More Information

No publications provided by USC/Norris Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Malcolm C. Pike Ph.D., USC Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT00972439     History of Changes
Other Study ID Numbers: HS-07-00269
Study First Received: September 3, 2009
Last Updated: September 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by USC/Norris Comprehensive Cancer Center:
Oral Contraceptives
Breast Tissue

Additional relevant MeSH terms:
Contraceptive Agents
Norinyl
Ethynylestradiol mixture with norethindrone
Norethindrone
Contraceptives, Oral
Progestins
Mestranol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Therapeutic Uses
Contraceptive Agents, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential
Contraceptives, Oral, Synthetic
Estrogens

ClinicalTrials.gov processed this record on May 19, 2013