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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 31, 2019

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

  • Drug: Ulipristal 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.

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • luteal hormone levels
    • Time Frame: 8 weeks from start of study, approximately
    • luteal hormone levels
  • progesterone hormone levels
    • Time Frame: 8 weeks from start of study, approximately
    • progesterone hormone levels
  • maximum follicle diameter
    • Time Frame: 8 weeks from start of study, approximately
    • maximum ovarian follicle diameter

Participating in This Clinical Trial

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

Gender Eligibility: Female

This study is evaluating efficacy of these medications in prevention of ovulation.

Minimum Age: 18 Years

Maximum Age: 38 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Erica Cahill, Clinical Instructor – Stanford University

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