N/A
N=33
Oral Contraceptive (OC) Progestin Dose and Breast Proliferation
Oral Contraceptive
Bottom Line
View on ClinicalTrials.gov: NCT00972439 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups — 7.5; 12.4 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 Fe® (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Southern California
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups |
7.5; 12.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18-34.
- Premenopausal.
- Currently taking or want to start oral contraceptives for contraception
- Non-smoker.
- Competent to give informed consent (as judged by the investigator).
- Provided written informed consent.
- 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.
- Abnormal breast examination.
- 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.
- Currently pregnant or pregnant within the previous 6 months.
- Having any standard contra-indication to being prescribed OCs.
Data sourced from ClinicalTrials.gov (NCT00972439). 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.