Trial Outcomes & Findings for Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation (NCT NCT01318005)
NCT ID: NCT01318005
Last Updated: 2026-02-17
Results Overview
Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
Up to 3 months.
Results posted on
2026-02-17
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
26
|
26
|
|
Overall Study
COMPLETED
|
30
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation
Baseline characteristics by cohort
| Measure |
Ortho-Novum® 1/35
n=30 Participants
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.
|
Ovcon® 35
n=26 Participants
Ovcon® 35 is an oral contraceptive that contains less progestin.
Oral Contraceptive: Ovcon® 35: Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.
|
Microgestin Fe® 1/20
n=26 Participants
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.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26 years
n=25 Participants
|
28.5 years
n=20 Participants
|
26 years
n=45 Participants
|
28.5 years
n=76 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=25 Participants
|
26 Participants
n=20 Participants
|
26 Participants
n=45 Participants
|
82 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=25 Participants
|
11 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
33 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=25 Participants
|
15 Participants
n=20 Participants
|
20 Participants
n=45 Participants
|
49 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=25 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
9 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=25 Participants
|
6 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
14 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=25 Participants
|
18 Participants
n=20 Participants
|
19 Participants
n=45 Participants
|
59 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=25 Participants
|
26 participants
n=20 Participants
|
26 participants
n=45 Participants
|
82 participants
n=76 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months.Population: 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.
Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells
Outcome measures
| Measure |
Ortho-Novum® 1/35
n=25 Participants
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.
|
Ovcon® 35
n=19 Participants
Ovcon® 35 is an oral contraceptive that contains less progestin.
Oral Contraceptive: Ovcon® 35: Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.
|
Microgestin Fe® 1/20
n=24 Participants
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.
|
|---|---|---|---|
|
Breast Cell Proliferation Levels Between the Three Oral Contraceptive Groups
|
8.5 Percent of cells staining for Ki67
Interval 5.7 to 12.5
|
11.9 Percent of cells staining for Ki67
Interval 7.5 to 18.9
|
7.5 Percent of cells staining for Ki67
Interval 4.8 to 11.7
|
Adverse Events
Ortho-Novum® 1/35
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ovcon® 35
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Microgestin Fe® 1/20
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Victoria Soto, Regulatory Manager
USC Norris Comprehensive Cancer Center
Phone: 323-865-0432
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place