Trial Outcomes & Findings for Oral Contraceptive (OC) Progestin Dose and Breast Proliferation (NCT NCT00972439)

NCT ID: NCT00972439

Last Updated: 2018-02-23

Results Overview

Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

32 weeks

Results posted on

2018-02-23

Participant Flow

Recruitment dates: April 2008 - October 2008 Ob/gyn clinics

Participant milestones

Participant milestones
Measure	Ortho-Novum® 1/35 Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.	Ovcon Fe® Ovcon Fe® is an oral contraceptive that contains less progestin.
Overall Study STARTED	17	16
Overall Study COMPLETED	17	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ortho-Novum® 1/35 n=17 Participants Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.	Ovcon Fe® n=16 Participants Ovcon Fe® is an oral contraceptive that contains less progestin.	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	25.3 years STANDARD_DEVIATION 4.4 • n=5 Participants	28.1 years STANDARD_DEVIATION 4.8 • n=7 Participants	26.8 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 32 weeks

Population: 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.

Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells

Outcome measures

Outcome measures
Measure	Ortho-Novum® 1/35 n=14 Participants Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.	Ovcon Fe® n=13 Participants Ovcon Fe® is an oral contraceptive that contains less progestin.
Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups	7.5 Percent of cells staining for Ki67 Interval 3.8 to 14.6	12.4 Percent of cells staining for Ki67 Interval 6.3 to 24.2

Adverse Events

Ortho-Novum® 1/35

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ovcon Fe®

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

Celeste Pearce, Ph.D.

USC/Norris Comprehensive Cancer Center

Phone: 323 865 0437

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place