Text Size

Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation (OCP2)

This study is currently recruiting participants.
Verified August 2012 by USC/Norris Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01318005
First received: March 16, 2011
Last updated: August 16, 2012
Last verified: August 2012
History of Changes

March 16, 2011
August 16, 2012
January 2011
June 2013   (final data collection date for primary outcome measure)
To measure breast cell proliferation levels between the three oral contraceptive dose groups. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01318005 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation
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?

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Oral Contraceptive
  • Drug: Oral Contraceptive: Ortho-Novum® 1/35
    Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily.
  • Drug: Oral Contraceptive: Ovcon® 35
    Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.
  • Drug: Oral Contraceptive: Microgestin Fe® 1/20
    Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily.
  • Active Comparator: Ortho-Novum® 1/35
    Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
    Intervention: Drug: Oral Contraceptive: Ortho-Novum® 1/35
  • Active Comparator: Ovcon® 35
    Ovcon® 35 is an oral contraceptive that contains less progestin.
    Intervention: Drug: Oral Contraceptive: Ovcon® 35
  • Active Comparator: Microgestin Fe® 1/20
    is an oral contraceptive that contains less estrogen.
    Intervention: Drug: Oral Contraceptive: Microgestin Fe® 1/20
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
85
December 2014
June 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
Yes
Contact: Anna H Wu, Ph.D. 323 865 0484 annawu@usc.edu
Contact: Leticia Vasquez-Caldera, B.A. 323 865 0407 vasquezc@usc.edu
United States
 
NCT01318005
HS-10-00455
No
USC/Norris Comprehensive Cancer Center
USC/Norris Comprehensive Cancer Center
Not Provided
Principal Investigator: Heather MacDonald, M.D. University of Southern California
USC/Norris Comprehensive Cancer Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP