Clinical trial NCT03354117: On Demand Contraception: Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility
Official title: On Demand Contraception: Investigating Efficacy of Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contraception
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single, open-label trial of one-time dosing of ulipristal acetate and meloxicam at a peak fertility time point.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: ovulatory disruption
timeFrame: 8 weeks from start of study, approximately
Secondary outcomes:
measure: luteal hormone levels
timeFrame: 8 weeks from start of study, approximately
measure: progesterone hormone levels
timeFrame: 8 weeks from start of study, approximately
measure: maximum follicle diameter
timeFrame: 8 weeks from start of study, approximately
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
citation: 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.