The aim of this study is to determine the recommendations for the use of a backup method for new start oral contraceptive users. While oral contraceptive are commonly prescribed, there is no consensus of recommendations for a backup method for new start patients. Package insert instructions are confusing; this may lead to noncompliance and undesired pregnancies. Experts generally agree that starting pills no later than day 5 of menses ensures immediate protection. However, a Sunday start adds the risk of breakthrough ovulation since the first pill can be started as late as day 7 of the menstrual cycle. Clinical practice favors advising new start patients to use a backup in the first week to month, regardless of start regimen. This study is a prospective and randomized clinical trial. One hundred and twenty subjects will be recruited. It is designed to compare three pill start regimens of Lo/Ovral, day 1 of menses, (the shortest window), day 4, (the intermediate window), and day 7, (the longest window) in regard to ovulation rate and ovarian follicle formation. The primary analysis will be to test the null hypotheses that the averages of the maximum follicular diameter and the ovulation rates are equal for the three groups. Descriptive analyses of follicular diameter assessments and changes, and endometrial lining will also be provided. Serum progesterone levels will be summarized and evaluated for evidence of ovulation. Comparing these regimens will provide information about how the pill works in the initial cycle of use and may lead to improved patient compliance.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000056-39
Application #
6409152
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1978-12-01
Project End
2003-11-30
Budget Start
Budget End
Support Year
39
Fiscal Year
2000
Total Cost
Indirect Cost
Name
University of Pittsburgh
Department
Type
DUNS #
053785812
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
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