Oral Contraceptive
Conditions
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 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.
Interventions
Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily.
DRUGOral Contraceptive: Ovcon® 35
Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.
DRUGOral Contraceptive: Microgestin Fe® 1/20
Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily.
Sponsors
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 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18-35 2. BMI \<30 kg/m2 3. Premenopausal with regular cycles or currently taking an OC 4. Not currently or recently pregnant or nursing (within previous 6 months) 5. Non-smoker 6. No use of antibiotics within the prior 4 weeks 7. Competent to provide written informed consent (as judged by study team) 8. Willing to adhere to the OC regimen 9. Willingness to refrain from the use of aspirin or NSAIDS 10 days pior to the biopsy appointment and one week following the biopsy procedure 10. Willing and able to refrain from use of fish oils 10 days prior to the biopsy appointment and one week following the biopsy procedure
Exclusion criteria
1. Diabetes 2. Abnormal breast examination 3. Abnormal PT/INR and/or CBC with platelets test results (as determined by one of the study physicians) 4. History or current therapeutic or prophylactic use of anticoagulants 5. Known bleeding disorder or history of unexplained bleeding or bruising 6. History of breast cancer or previous diagnostic breast biopsy 7. Known allergy to local anesthetic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast Cell Proliferation Levels Between the Three Oral Contraceptive Groups | Up to 3 months. | Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHeather MacDonald, M.D.
University of Southern California
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 28.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 59 Participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 30 | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 30 | 0 / 26 | 0 / 26 |
Outcome results
None listed