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
|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|
|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|
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.
- To measure breast cell proliferation levels between the three oral contraceptive dose groups. [ Time Frame: 2 years ]
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
|Contact: Anna H Wu, Ph.D.||323 865 firstname.lastname@example.org|
|Contact: Leticia Vasquez-Caldera, B.A.||323 865 email@example.com|
|United States, California|
|USC University Hospital||Recruiting|
|Los Angeles, California, United States, 90033|
|Principal Investigator: Heather MacDonald, M.D.|
|Principal Investigator:||Heather MacDonald, M.D.||University of Southern California|