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

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ClinicalTrials.gov Identifier: NCT01318005
Recruitment Status : Unknown
Verified September 2014 by University of Southern California.
Recruitment status was:  Recruiting
First Posted : March 18, 2011
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
University of Southern California

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. This research will also test whether the results found in HS-07-00269 can be confirmed.

Condition or disease Intervention/treatment Phase
Oral Contraceptive Drug: Oral Contraceptive: Ortho-Novum® 1/35 Drug: Oral Contraceptive: Ovcon® 35 Drug: Oral Contraceptive: Microgestin Fe® 1/20 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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?
Study Start Date : January 2011
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Binovum
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Ortho-Novum® 1/35
Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
Drug: Oral Contraceptive: Ortho-Novum® 1/35
Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily.
Active Comparator: Ovcon® 35
Ovcon® 35 is an oral contraceptive that contains less progestin.
Drug: Oral Contraceptive: Ovcon® 35
Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.
Active Comparator: Microgestin Fe® 1/20
is an oral contraceptive that contains less estrogen.
Drug: Oral Contraceptive: Microgestin Fe® 1/20
Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily.



Primary Outcome Measures :
  1. To measure breast cell proliferation levels between the three oral contraceptive dose groups. [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318005


Contacts
Contact: Anna H Wu, Ph.D. 323 865 0484 annawu@usc.edu
Contact: Leticia Vasquez-Caldera, B.A. 323 865 0407 vasquezc@usc.edu

Locations
United States, California
USC University Hospital Recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Heather MacDonald, M.D.         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Heather MacDonald, M.D. University of Southern California

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01318005     History of Changes
Other Study ID Numbers: HS-10-00455
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Contraceptive Agents
Norinyl
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Norethindrone
Estrogens
Mestranol
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential
Contraceptives, Oral, Synthetic