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

Stanford University

Status and phase: Completed; Phase 1

Conditions: Contraception

Treatments: Drug: Ulipristal Acetate 30 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03354117

43881

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Ulipristal 30mg plus Meloxicam 15mg

Experimental group

Description:

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.

Treatment:

Drug: Ulipristal Acetate 30 MG Oral Tablet