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Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00972439
First Posted: September 7, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
United States Department of Defense
Information provided by:
University of Southern California
  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: None (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:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • To measure breast cell proliferation levels between the two oral contraceptive dose groups.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972439


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

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
First Submitted: September 3, 2009
First Posted: September 7, 2009
Last Update Posted: October 12, 2017
Last Verified: September 2009

Keywords provided by University of Southern California:
Oral Contraceptives
Breast Tissue

Additional relevant MeSH terms:
Contraceptive Agents
Norinyl
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Norethindrone
Contraceptives, Oral
Progestins
Mestranol
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential
Contraceptives, Oral, Synthetic
Estrogens