The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle
The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.
Ovulation (Follicular Rupture Yes/no)
Menstrual Cycles (Total Length, Bleeding Days)
Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
|Official Title:||The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle.|
- Menstrual Cycle Length [ Time Frame: 3 months ] [ Designated as safety issue: No ]Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.
|Study Start Date:||January 2008|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
One 400mg tablet daily.
|Placebo Comparator: 2||
One tablet daily.
Currently available methods of emergency contraception (EC) only work during a very narrow time period prior to the hormonal trigger for ovulation or the release of an egg. Women having unprotected sex outside this window receive no benefits from this emergency therapy. Prostaglandins are critical before, during, and after ovulation, thus their inhibition may cause an EC effect that works over a longer time period. We wanted to determine if celecoxib might work as an EC with a wider window of action.
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Alison Edelman, MD, MPH||Oregon Health and Science University|