Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation

Oral Contraceptive Clinical Trial

— OCP2  

Official title:

The Effects of Dose and Formulation of Oral Contraceptives (OCs) on Breast-Cell Proliferation: Can the Chemopreventive Effects of OCs on Endometrial and Ovarian Cancer be Extended to Breast Cancer?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01318005
• Other study ID #: HS-10-00455
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2011
• Last updated: September 9, 2014
• Start date: January 2011
• Est. completion date: December 2016

Study information

• Verified date: September 2014
• Source: University of Southern California
• Contact: Anna H Wu, Ph.D.
• Phone: 323 865 0484
• Email: annawu[@]usc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• 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 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. This research will also test whether the results found in HS-07-00269 can be confirmed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: December 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Oral Contraceptive

Intervention

Drug:
• Oral Contraceptive: Ortho-Novum® 1/35
Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily.
• Oral Contraceptive: Ovcon® 35
Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.
• Oral Contraceptive: Microgestin Fe® 1/20
Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily.

Locations

Country	Name	City	State
United States	USC University Hospital	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure breast cell proliferation levels between the three oral contraceptive dose groups.		2 years	No