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



Status:Recruiting
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 35
Updated:6/7/2018
Start Date:March 15, 2018
End Date:July 31, 2019
Contact:Erica Cahill, MD
Email:epcahill@stanford.edu
Phone:6507211562

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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.

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.

Inclusion Criteria:

Women, aged 18-35

- 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
We found this trial at
1
site
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Phone: 650-721-1562
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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