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

• Status: Completed
• Trial end date: 2019-05-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Stanford University
• Treatments: Cyclooxygenase 2 Inhibitors; Meloxicam; Ulipristal acetate

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