Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

Oral Contraceptive Clinical Trial

Official title:

Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972439
• Other study ID #: HS-07-00269
• Status: Completed
• Phase: N/A
• First received: September 3, 2009
• Last updated: January 24, 2018
• Start date: August 2007
• Est. completion date: November 2008

Study information

• Verified date: December 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oral Contraceptive

Intervention

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

• Oral Contraceptive: Ovcon Fe®

Locations

Country	Name	City	State
United States	Los Angeles County Hospital	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	32 weeks