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...
Date First Received: September 3, 2009
Last Updated: September 4, 2009
Verified by: USC/Norris Comprehensive Cancer Center, September 2009
Clinical Trial Phase: N/A | Start Date: August 2007
Overall Status: Completed
Estimated Enrollment: 40
Brief Summary
Official Title: “Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation”
Condition Keyword(s):
Additional Keyword(s) Provided by Sponsor:
Intervention MeSH Term(s), Assigned with an Experimental Algorithm:
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.
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Dose Comparison, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Study Primary Completion Date: November 2008
Intervention(s) in this Clinical Trial
- Drug: Oral Contraceptive: Ortho-Novum® 1/35
- Drug: Oral Contraceptive: Ovcon Fe®
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: Ortho-Novum® 1/35
- Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
- Active Comparator: Ovcon Fe®
- Ovcon Fe® is an oral contraceptive that contains less progestin.
Outcome Measures for this Clinical Trial
Primary Measures
- To measure breast cell proliferation levels between the two oral contraceptive dose groups.
- Safety Issue?: No
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 34 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: USC/Norris Comprehensive Cancer Center
Overall Clinical Trial Officials and Contacts
DeShawn Taylor, M.D. Principal Investigator University of Southern California
Additional Information
Information obtained from ClinicalTrials.gov on September 01, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00972439
Study ID Number: HS-07-00269
ClinicalTrials.gov Identifier: NCT00972439
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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