Oral Contraceptive
Conditions
Keywords
Oral Contraceptives, Breast Tissue
Brief summary
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.
Interventions
DRUGOral Contraceptive: Ovcon Fe®
Sponsors
United States Department of Defense
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 34 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18-34. 2. Premenopausal. 3. Currently taking or want to start oral contraceptives for contraception 4. Non-smoker. 5. Competent to give informed consent (as judged by the investigator). 6. Provided written informed consent. 7. Willingness to refrain from smoking and consumption of grapefruit or grapefruit juice during the study (grapefruit interferes with metabolism of exogenously administered OCs).
Exclusion criteria
1. 1. Abnormal breast examination. 2. History or current therapeutic or prophylactic use of anticoagulants. 3. Known bleeding disorder or history of unexplained bleeding or bruising. 4. History of breast cancer or previous diagnostic breast biopsy. 5. Known allergy to local anesthetic. 6. Currently pregnant or pregnant within the previous 6 months. 7. Having any standard contra-indication to being prescribed OCs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups | 32 weeks | Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells |
Countries
United States
Participant flow
Recruitment details
Recruitment dates: April 2008 - October 2008 Ob/gyn clinics
Participants by arm
| Arm | Count |
|---|---|
| Ortho-Novum® 1/35 Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. | 17 |
| Ovcon Fe® Ovcon Fe® is an oral contraceptive that contains less progestin. | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | Ovcon Fe® | Ortho-Novum® 1/35 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 17 Participants | 33 Participants |
| Age, Continuous | 28.1 years STANDARD_DEVIATION 4.8 | 25.3 years STANDARD_DEVIATION 4.4 | 26.8 years STANDARD_DEVIATION 4.8 |
| Region of Enrollment United States | 16 Participants | 17 Participants | 33 Participants |
| Sex: Female, Male Female | 16 Participants | 17 Participants | 33 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 0 / 17 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
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
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ortho-Novum® 1/35 | Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups | 7.5 Percent of cells staining for Ki67 |
| Ovcon Fe® | Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups | 12.4 Percent of cells staining for Ki67 |