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Completed

NCT Number: NCT03354117

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

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.

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Key information

Conditions

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ulipristal Acetate 30 MG Oral Tablet

Drug

Each study participant will receive one dose of the study medication (ulipristal acetate 30mg plus meloxicam 15mg) at peak fertility in the treatment cycle.

Other names: Meloxicam

Primary outcomes

  1. 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

  1. luteal hormone levels

    Time frame: 8 weeks from start of study, approximately

    luteal hormone levels

  2. progesterone hormone levels

    Time frame: 8 weeks from start of study, approximately

    progesterone hormone levels

  3. maximum follicle diameter

    Time frame: 8 weeks from start of study, approximately

    maximum ovarian follicle diameter

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2017
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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