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

NCT03354117 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 43881
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• ovulatory disruption

  (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 Outcomes (3)

• luteal hormone levels

  8 weeks from start of study, approximately

• progesterone hormone levels

  8 weeks from start of study, approximately

• maximum follicle diameter

  8 weeks from start of study, approximately

Study Arms (1)

Ulipristal 30mg plus Meloxicam 15mg

EXPERIMENTAL

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

Interventions

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.

Also known as: Meloxicam

Ulipristal 30mg plus Meloxicam 15mg

Eligibility Criteria

• Age: 18 Years - 38 Years
• Gender Eligibility Details: This study is evaluating efficacy of these medications in prevention of ovulation.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• Cahill EP, Lerma K, Shaw KA, Blumenthal PD. Potential candidate for oral pericoital contraception: evaluating ulipristal acetate plus cyclo-oxygenase-2 inhibitor for ovulation disruption. BMJ Sex Reprod Health. 2022 Jul;48(3):217-221. doi: 10.1136/bmjsrh-2021-201446. Epub 2022 Apr 25.

  PMID: 35470225 DERIVED

MeSH Terms

Interventions

ulipristal acetate; Tablets; Meloxicam

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Model Details: Single, open-label trial of one-time dosing of ulipristal acetate and meloxicam at a peak fertility time point.

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: March 15, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)