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

June 24, 2019 updated by: Erica Cahill, Stanford University

On Demand Contraception: Investigating Efficacy of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Meloxicam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks from start of study, approximately

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2018

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 24, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43881

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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