On Demand Contraception: Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility

Study Overview
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Brief Summary
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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
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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.

Official Title
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On Demand Contraception: Investigating Efficacy of Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility

Conditions
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Contraception

Intervention / Treatment
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* Drug: Ulipristal Acetate 30 MG Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Single, open-label trial of one-time dosing of ulipristal acetate and meloxicam at a peak fertility time point.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulipristal 30mg plus Meloxicam 15mg<br>Each study participant will complete one menstrual cycle without medication. Her second menstrual cycle, each study participant will receive ulipristal acetate plus meloxicam at peak fertility. | Drug: Ulipristal Acetate 30 MG Oral Tablet<br>* Each study participant will receive one dose of the study medication (ulipristal acetate 30mg plus meloxicam 15mg) at peak fertility in the treatment cycle.<br>* Other names: Meloxicam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 weeks from start of study, approximately | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| luteal hormone levels | luteal hormone levels | 8 weeks from start of study, approximately | 
| progesterone hormone levels | progesterone hormone levels | 8 weeks from start of study, approximately | 
| maximum follicle diameter | maximum ovarian follicle diameter | 8 weeks from start of study, approximately |