On Demand Contraception: Investigating Efficacy of Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- ovulatory disruption
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 38 Years (Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Ulipristal 30mg plus Meloxicam 15mg
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.
Intervention: Ulipristal Acetate 30 MG Oral Tablet (Drug)
Outcomes
Primary Outcomes
ovulatory disruption
Time Frame: 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 Outcomes
- progesterone hormone levels(8 weeks from start of study, approximately)
- luteal hormone levels(8 weeks from start of study, approximately)
- maximum follicle diameter(8 weeks from start of study, approximately)
Investigators
Erica Cahill
Clinical Instructor
Stanford University