Status:
COMPLETED
On Demand Contraception: Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility
Lead Sponsor:
Stanford University
Conditions:
Contraception
Eligibility:
FEMALE
18-38 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03354117
Start Date
March 15 2018
End Date
May 31 2019
Last Update
June 25 2019
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305