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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03354117
Recruitment Status : Completed
First Posted : November 27, 2017
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Erica Cahill, 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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Ulipristal Acetate 30 MG Oral Tablet Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single, open-label trial of one-time dosing of ulipristal acetate and meloxicam at a peak fertility time point.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: On Demand Contraception: Investigating Efficacy of Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility
Actual Study Start Date : March 15, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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 Name: Meloxicam




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is evaluating efficacy of these medications in prevention of ovulation.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354117


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Responsible Party: Erica Cahill, Clinical Instructor, Stanford University
ClinicalTrials.gov Identifier: NCT03354117    
Other Study ID Numbers: 43881
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Meloxicam
Ulipristal acetate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents