This is an exploratory prospective study investigating if addition of a COX-2 inhibitor can increase efficacy of ulipristal in disrupting ovulation at peak fertility.
This is an exploratory prospective study investigating if addition of a COX-2 inhibitor can increase efficacy of ulipristal in disrupting ovulation at peak fertility. We will compare the proportion of women with ovulatory disruption after taking the study medications with those women's own placebo cycles and also to previously established/published rates of ovulatory disruption of ulipristal alone.9 Given the established efficacy of ulipristal during the follicular time period as well as the theoretical mechanism of meloxicam to disrupt cumulus-oocyte expansion is a late step in ovulation, we hypothesize that this medication could emerge as the best candidate for an oral on-demand contraceptive option.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
12
Each study participant will receive one dose of the study medication (ulipristal acetate 30mg plus meloxicam 15mg) at peak fertility in the treatment cycle.
Stanford University
Stanford, California, United States
ovulatory disruption
(1) no follicle rupture or (2) follicle rupture that was (a) not preceded within 24-48 hours by an LH peak, (b) preceded by a blunted LH peak (\<21IU/L), and/or (c) followed by a luteal phase progesterone peak of \<3ng/mL
Time frame: 8 weeks from start of study, approximately
luteal hormone levels
luteal hormone levels
Time frame: 8 weeks from start of study, approximately
progesterone hormone levels
progesterone hormone levels
Time frame: 8 weeks from start of study, approximately
maximum follicle diameter
maximum ovarian follicle diameter
Time frame: 8 weeks from start of study, approximately
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