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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354117
• Other study ID #: 43881
• Status: Completed
• Phase: Phase 1
• Start date: March 15, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: June 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	luteal hormone levels	luteal hormone levels	8 weeks from start of study, approximately
Secondary	progesterone hormone levels	progesterone hormone levels	8 weeks from start of study, approximately
Secondary	maximum follicle diameter	maximum ovarian follicle diameter	8 weeks from start of study, approximately