In this study the effect of piroxicam on the ovulation will be evaluated. Therefore piroxicam will be administered as a single-dose after onset of LH surge (luteinizing hormone, hormone which triggers ovulation). Additionally blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition the concentration of piroxicam in blood will be determined in regular intervals. With regards to the tolerability of the study drug subjects will be asked regularly how they feel.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
72
Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule)
Single dose of 40 mg piroxicam (i.e., 2 piroxicam capsules + 2 placebo capsule)
Single dose of placebo (i.e., 4 placebo capsules)
Unnamed facility
Berlin, State of Berlin, Germany
Effect of piroxicam on ovulation (delay or inhibition) when given after the onset of LH surge
Time frame: after 2 months
course of follicle sizes
Time frame: after 2 months
course of gonadotropins (follicle-stimulating hormone [FSH], LH) and ovarian steroids (estradiol [E2], progesterone)
Time frame: after 2 months
Concentration-times courses of piroxicam
Time frame: after 2 months
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Single dose of 80 mg piroxicam (i.e., 4 piroxicam capsules)