Contraception
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGUlipristal Acetate 30 MG Oral Tablet
Each study participant will receive one dose of the study medication (ulipristal acetate 30mg plus meloxicam 15mg) at peak fertility in the treatment cycle.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single, open-label trial of one-time dosing of ulipristal acetate and meloxicam at a peak fertility time point.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
Yes
Inclusion criteria
Women, aged 18-38 * English speaking * Able to consent, literate * Access to smart phone throughout study * History of regular menses * Documented baseline cycle with ovulation * Not currently using or needing hormonal contraception * Not currently using or needing regular NSAIDS * Able to commit to frequency of study visits
Exclusion criteria
* Currently or recently (\<2months) pregnant * Currently or recent (\<2months) breastfeeding * Current or recent (\<2months) use of hormonal medication * Regular NSAID use * Known cardiac risk factors (e.g. personal history of obesity, HTN, cardiac disease, diabetes) * BMI \> 30, as some studies have shown decreased efficacy of ulipristal in obese women37 * Allergy or previous unacceptable side effects with study medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ovulatory disruption | 8 weeks from start of study, approximately | (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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| luteal hormone levels | 8 weeks from start of study, approximately | luteal hormone levels |
| progesterone hormone levels | 8 weeks from start of study, approximately | progesterone hormone levels |
| maximum follicle diameter | 8 weeks from start of study, approximately | maximum ovarian follicle diameter |
Countries
United States
Outcome results
None listed