Study of a COX-2 Inhibitor for Prevention of Ovulation
Status:
Unknown status
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
In this study the investigators propose to evaluate a COX-2 inhibitor(meloxicam) to assess
its effect on follicular development and find out if this regimen delays or blocks ovulation
while maintaining ovarian cyclicity. The investigators intend to administer 15 mg or 30 mg of
meloxicam per day for 18 days starting on day 5 after onset of menses during 3 continuous
cycles. The 3 treatment cycles will be preceded and followed by control cycles with no
treatment. Ovulation or lack there of will be monitored by transvaginal ultrasound
examinations (TVUs), estradiol, luteinizing hormone (LH), and progesterone levels in multiple
blood samples in each cycle. The investigators will recruit a total of 56 women. Each woman
will be randomly assigned to 1 of the 2 dose regimens of meloxicam, with 28 women assigned to
each of the 2 dose regimens. Participating women will demonstrate an ovulatory cycle before
starting meloxicam treatment and will be protected from pregnancy by prior sterilization.