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Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

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ClinicalTrials.gov Identifier: NCT00972439
Recruitment Status : Completed
First Posted : September 7, 2009
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Southern California

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Oral Contraceptive
Interventions Drug: Oral Contraceptive: Ortho-Novum® 1/35
Drug: Oral Contraceptive: Ovcon Fe®
Enrollment 33
Recruitment Details Recruitment dates: April 2008 - October 2008 Ob/gyn clinics
Pre-assignment Details  
Arm/Group Title Ortho-Novum® 1/35 Ovcon Fe®
Hide Arm/Group Description Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. Ovcon Fe® is an oral contraceptive that contains less progestin.
Period Title: Overall Study
Started 17 16
Completed 17 16
Not Completed 0 0
Arm/Group Title Ortho-Novum® 1/35 Ovcon Fe® Total
Hide Arm/Group Description Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. Ovcon Fe® is an oral contraceptive that contains less progestin. Total of all reporting groups
Overall Number of Baseline Participants 17 16 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
16
 100.0%
33
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 16 participants 33 participants
25.3  (4.4) 28.1  (4.8) 26.8  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
Female
17
 100.0%
16
 100.0%
33
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 17 participants 16 participants 33 participants
17
 100.0%
16
 100.0%
33
 100.0%
1.Primary Outcome
Title Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups
Hide Description Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells
Time Frame 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Five of the breast biopsy specimens contained insufficient TDLU epithelial tissue for analysis and one of the remaining women was diagnosed with a follicular cyst on the day of the biopsy, leaving 27 evaluable women.
Arm/Group Title Ortho-Novum® 1/35 Ovcon Fe®
Hide Arm/Group Description:
Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
Ovcon Fe® is an oral contraceptive that contains less progestin.
Overall Number of Participants Analyzed 14 13
Mean (95% Confidence Interval)
Unit of Measure: Percent of cells staining for Ki67
7.5
(3.8 to 14.6)
12.4
(6.3 to 24.2)
Time Frame Adverse events were collected beginning day 1 of study and continued throughout the study until 30 days after the last dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ortho-Novum® 1/35 Ovcon Fe®
Hide Arm/Group Description Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. Ovcon Fe® is an oral contraceptive that contains less progestin.
All-Cause Mortality
Ortho-Novum® 1/35 Ovcon Fe®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/16 (0.00%) 
Hide Serious Adverse Events
Ortho-Novum® 1/35 Ovcon Fe®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ortho-Novum® 1/35 Ovcon Fe®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/16 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Celeste Pearce, Ph.D.
Organization: USC/Norris Comprehensive Cancer Center
Phone: 323 865 0437
EMail: cpearce@usc.edu
Layout table for additonal information
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00972439    
Other Study ID Numbers: HS-07-00269
First Submitted: September 3, 2009
First Posted: September 7, 2009
Results First Submitted: February 14, 2013
Results First Posted: February 23, 2018
Last Update Posted: February 23, 2018