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

Phase 1

Completed

• Conditions: Contraception
• Interventions: Drug: Ulipristal Acetate 30 MG Oral Tablet

• Registration Number: NCT03354117
• Lead Sponsor: Stanford University

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 Timeline

• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-27
• Study Start: 2018-03-15
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-24
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ulipristal 30mg plus Meloxicam 15mg	Ulipristal Acetate 30 MG Oral Tablet	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
progesterone hormone levels	8 weeks from start of study, approximately	progesterone hormone levels
luteal hormone levels	8 weeks from start of study, approximately	luteal hormone levels
maximum follicle diameter	8 weeks from start of study, approximately	maximum ovarian follicle diameter

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States