Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation

NCT01318005 | Completed Results

• 1 other identifier: HS-10-00455
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Contraceptive

Outcome Measures

Primary Outcomes (1)

• Breast Cell Proliferation Levels Between the Three Oral Contraceptive Groups

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

  Up to 3 months.

Study Arms (3)

Ortho-Novum® 1/35

ACTIVE COMPARATOR

Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.

Drug: Oral Contraceptive: Ortho-Novum® 1/35

Ovcon® 35

ACTIVE COMPARATOR

Ovcon® 35 is an oral contraceptive that contains less progestin.

Drug: Oral Contraceptive: Ovcon® 35

Microgestin Fe® 1/20

ACTIVE COMPARATOR

is an oral contraceptive that contains less estrogen.

Drug: Oral Contraceptive: Microgestin Fe® 1/20

Interventions

Oral Contraceptive: Ortho-Novum® 1/35 DRUG

Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily.

Ortho-Novum® 1/35

Oral Contraceptive: Ovcon® 35 DRUG

Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.

Ovcon® 35

Oral Contraceptive: Microgestin Fe® 1/20 DRUG

Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily.

Microgestin Fe® 1/20

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

USC University Hospital

Los Angeles, California, 90033, United States

Location

Results Point of Contact

• Title: Victoria Soto, Regulatory Manager
• Organization: USC Norris Comprehensive Cancer Center

victoria.soto@med.usc.edu

323-865-0432

Study Officials

• Heather MacDonald, M.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: March 18, 2011
• Study Start: February 14, 2011
• Primary Completion: June 30, 2014
• Study Completion: June 30, 2015
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2018-01

Locations

US (1)