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Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

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ClinicalTrials.gov Identifier: NCT00972439
Recruitment Status : Completed
First Posted : September 7, 2009
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Oral Contraceptive Drug: Oral Contraceptive: Ortho-Novum® 1/35 Drug: Oral Contraceptive: Ovcon Fe® Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
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
Study Start Date : August 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Binovum
U.S. FDA Resources

Arm Intervention/treatment
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®



Primary Outcome Measures :
  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



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.

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 Angeles, 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00972439     History of Changes
Other Study ID Numbers: HS-07-00269
First Posted: September 7, 2009    Key Record Dates
Results First Posted: February 23, 2018
Last Update Posted: February 23, 2018
Last Verified: December 2017

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