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

NCT ID: NCT03354117

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2019-05-31

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.

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.

Conditions

Contraception

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ulipristal Acetate 30 MG Oral Tablet

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Meloxicam

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Erica Cahill

Clinical Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Stanford, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35470225 (View on PubMed)

Other Identifiers

43881

Identifier Type: -

Identifier Source: org_study_id