Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 estrogen (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 estrogen; this research will examine that in detail.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ortho-Novum® 1/35 | Active Comparator | Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. |
|
| Ovcon® 35 | Active Comparator | Ovcon® 35 is an oral contraceptive that contains less progestin. |
|
| Microgestin Fe® 1/20 | Active Comparator | is an oral contraceptive that contains less estrogen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Contraceptive: Ortho-Novum® 1/35 | Drug | Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breast Cell Proliferation Levels Between the Three Oral Contraceptive Groups | Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells | Up to 3 months. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Heather MacDonald, M.D. | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC University Hospital | Los Angeles | California | 90033 | United States |
Not provided
The study began recruiting in February 2011 and ended in March 2013. All participants were seen and treated in the medical clinics at the University of Southern California.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ortho-Novum® 1/35 | Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. Oral Contraceptive: Ortho-Novum® 1/35: Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily. |
| FG001 | Ovcon® 35 | Ovcon® 35 is an oral contraceptive that contains less progestin. Oral Contraceptive: Ovcon® 35: Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily. |
| FG002 | Microgestin Fe® 1/20 | is an oral contraceptive that contains less estrogen. Oral Contraceptive: Microgestin Fe® 1/20: Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ortho-Novum® 1/35 | Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. Oral Contraceptive: Ortho-Novum® 1/35: Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily. |
| BG001 | Ovcon® 35 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Three Oral Contraceptive Groups | Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells | One participant was diagnosed with follicular cyst on the day of biopsy, 7 had insufficient specimen, 3 had low levels of corticosteroid binding globulin (CBG) and were dropped as being inconsistent users, while 3 had no CBG data available and were dropped for consistency, leaving 68 evaluable participants. | Posted | Mean | 95% Confidence Interval | Percent of cells staining for Ki67 | Up to 3 months. |
|
Not provided
Not provided
Not provided
| 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. Oral Contraceptive: Ortho-Novum® 1/35: Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Soto, Regulatory Manager | USC Norris Comprehensive Cancer Center | 323-865-0432 | victoria.soto@med.usc.edu |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oral Contraceptive: Ovcon® 35 | Drug | Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily. |
|
| Oral Contraceptive: Microgestin Fe® 1/20 | Drug | Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily. |
|
Ovcon® 35 is an oral contraceptive that contains less progestin.
Oral Contraceptive: Ovcon® 35: Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.
| BG002 | Microgestin Fe® 1/20 | is an oral contraceptive that contains less estrogen. Oral Contraceptive: Microgestin Fe® 1/20: Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ovcon® 35 |
Ovcon® 35 is an oral contraceptive that contains less progestin. Oral Contraceptive: Ovcon® 35: Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily. |
| OG002 | Microgestin Fe® 1/20 | Microgestin Fe® 1/20 is an oral contraceptive that contains less estrogen. Oral Contraceptive: Microgestin Fe® 1/20: Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily. |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Ovcon® 35 | Ovcon® 35 is an oral contraceptive that contains less progestin. Oral Contraceptive: Ovcon® 35: Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily. | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | Microgestin Fe® 1/20 | is an oral contraceptive that contains less estrogen. Oral Contraceptive: Microgestin Fe® 1/20: Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily. | 0 | 26 | 0 | 26 | 0 | 26 |
Not provided
Not provided
Not provided