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
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|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|
|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|
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®
- 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
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|Ages Eligible for Study:||18 Years to 34 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- Age 18-34.
- Currently taking or want to start oral contraceptives for contraception
- 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).
- 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.
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
|United States, California|
|Los Angeles County Hospital|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||DeShawn Taylor, M.D.||University of Southern California|
|Responsible Party:||University of Southern California|
|Other Study ID Numbers:||
|First Posted:||September 7, 2009 Key Record Dates|
|Results First Posted:||February 23, 2018|
|Last Update Posted:||February 23, 2018|
|Last Verified:||December 2017|
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Contraceptive Agents, Hormonal