N/A
N=82
Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation
Oral Contraceptive
Bottom Line
View on ClinicalTrials.gov: NCT01318005 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Breast Cell Proliferation Levels Between the Three Oral Contraceptive Groups — 8.5; 11.9; 7.5 Percent of cells staining for Ki67
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oral Contraceptive: Ortho-Novum® 1/35 (Drug); Oral Contraceptive: Ovcon® 35 (Drug); Oral Contraceptive: Microgestin Fe® 1/20 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Southern California
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breast Cell Proliferation Levels Between the Three Oral Contraceptive Groups |
8.5; 11.9; 7.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18-35
- BMI <30 kg/m2
- Premenopausal with regular cycles or currently taking an OC
- Not currently or recently pregnant or nursing (within previous 6 months)
- Non-smoker
- No use of antibiotics within the prior 4 weeks
- Competent to provide written informed consent (as judged by study team)
- Willing to adhere to the OC regimen
- Willingness to refrain from the use of aspirin or NSAIDS 10 days pior to the biopsy appointment and one week following the biopsy procedure
- 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
- Diabetes
- Abnormal breast examination
- Abnormal PT/INR and/or CBC with platelets test results (as determined by one of the study physicians)
- History or current therapeutic or prophylactic use of anticoagulants
- Known bleeding disorder or history of unexplained bleeding or bruising
- History of breast cancer or previous diagnostic breast biopsy
- Known allergy to local anesthetic
Data sourced from ClinicalTrials.gov (NCT01318005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.