Ovulation Clinical Trial
Official title:
The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation
The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and non-steroidal anti-inflammatory drug) has on ovulation.
A prospective randomized double-blind crossover study of healthy reproductive-aged (18-35
years old) women with regular cycles, not currently using or needing hormonal contraception,
were recruited. Women will undergo ovarian ultrasound and serum hormone monitoring during
four menstrual cycles (control cycle, treatment cycle 1, washout cycle, treatment cycle 2).
Subjects received study drug (oral celecoxib 400 mg or placebo) either 1) once daily starting
on cycle day 8 and continuing until follicle rupture or the onset of next menses if follicle
rupture did not occur (pre-LH surge dosing) or 2) once daily beginning with the LH surge and
continued for 6 days (post-LH surge dosing). Women will be randomly assigned to one of the
above treatment schemes and received the other in the subsequent treatment cycle.
This study aims to determine if treatment with a highly selective COX2 inhibitor, celecoxib,
would be a more effective agent in terms of causing ovulatory dysfunction. This study also
aims to determine whether treatment with celecoxib would adversely affect luteal function.
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