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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ortho-Novum® 1/35 | Active Comparator | Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. |
|
| Ovcon Fe® | Active Comparator | Ovcon Fe® is an oral contraceptive that contains less progestin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Contraceptive: Ortho-Novum® 1/35 | Drug |
| ||
| Oral Contraceptive: Ovcon Fe® |
| Measure | Description | Time Frame |
|---|---|---|
| Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups | Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells | 32 weeks |
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Inclusion Criteria:
Exclusion Criteria:1.
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| Name | Affiliation | Role |
|---|---|---|
| DeShawn Taylor, M.D. | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles County Hospital | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22325110 | Derived | Hovanessian-Larsen L, Taylor D, Hawes D, Spicer DV, Press MF, Wu AH, Pike MC, Pearce CL. Lowering oral contraceptive norethindrone dose increases estrogen and progesterone receptor levels with no reduction in proliferation of breast epithelium: a randomized trial. Contraception. 2012 Sep;86(3):238-43. doi: 10.1016/j.contraception.2011.12.015. Epub 2012 Feb 9. |
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Recruitment dates: April 2008 - October 2008 Ob/gyn clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Ortho-Novum® 1/35 | Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. |
| FG001 | Ovcon Fe® | Ovcon Fe® is an oral contraceptive that contains less progestin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ortho-Novum® 1/35 | Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. |
| BG001 | Ovcon Fe® | Ovcon Fe® is an oral contraceptive that contains less progestin. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups | Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells | Five of the breast biopsy specimens contained insufficient TDLU epithelial tissue for analysis and one of the remaining women was diagnosed with a follicular cyst on the day of the biopsy, leaving 27 evaluable women. | Posted | Mean | 95% Confidence Interval | Percent of cells staining for Ki67 | 32 weeks |
|
Adverse events were collected beginning day 1 of study and continued throughout the study until 30 days after the last dose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ortho-Novum® 1/35 | Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Celeste Pearce, Ph.D. | USC/Norris Comprehensive Cancer Center | 323 865 0437 | cpearce@usc.edu |
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| Drug |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Ovcon Fe® | Ovcon Fe® is an oral contraceptive that contains less progestin. | 0 | 16 | 0 | 16 | 0 | 16 |
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