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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulipristal 30mg plus Meloxicam 15mg | Experimental | Each study participant will complete one menstrual cycle without medication. Her second menstrual cycle, each study participant will receive ulipristal acetate plus meloxicam at peak fertility. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulipristal Acetate 30 MG Oral Tablet | Drug | Each study participant will receive one dose of the study medication (ulipristal acetate 30mg plus meloxicam 15mg) at peak fertility in the treatment cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| luteal hormone levels | luteal hormone levels | 8 weeks from start of study, approximately |
| progesterone hormone levels | progesterone hormone levels |
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Inclusion Criteria:
Women, aged 18-38
Exclusion Criteria:
This study is evaluating efficacy of these medications in prevention of ovulation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35470225 | Derived | 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. |
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| ID | Term |
|---|---|
| C555622 | ulipristal acetate |
| D013607 | Tablets |
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
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Single, open-label trial of one-time dosing of ulipristal acetate and meloxicam at a peak fertility time point.
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|
| 8 weeks from start of study, approximately |
| maximum follicle diameter | maximum ovarian follicle diameter | 8 weeks from start of study, approximately |
| D009930 |
| Organic Chemicals |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |