On Demand Contraception: Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility
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ClinicalTrials.gov Identifier: NCT03354117 |
Recruitment Status :
Completed
First Posted : November 27, 2017
Last Update Posted : June 25, 2019
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Condition or disease | Intervention/treatment | Phase |
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Contraception | Drug: Ulipristal Acetate 30 MG Oral Tablet | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Single, open-label trial of one-time dosing of ulipristal acetate and meloxicam at a peak fertility time point. |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | On Demand Contraception: Investigating Efficacy of Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility |
Actual Study Start Date : | March 15, 2018 |
Actual Primary Completion Date : | May 31, 2019 |
Actual Study Completion Date : | May 31, 2019 |

Arm | Intervention/treatment |
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Experimental: Ulipristal 30mg plus Meloxicam 15mg
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.
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Drug: Ulipristal Acetate 30 MG Oral Tablet
Each study participant will receive one dose of the study medication (ulipristal acetate 30mg plus meloxicam 15mg) at peak fertility in the treatment cycle.
Other Name: Meloxicam |
- ovulatory disruption [ Time Frame: 8 weeks from start of study, approximately ](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
- luteal hormone levels [ Time Frame: 8 weeks from start of study, approximately ]luteal hormone levels
- progesterone hormone levels [ Time Frame: 8 weeks from start of study, approximately ]progesterone hormone levels
- maximum follicle diameter [ Time Frame: 8 weeks from start of study, approximately ]maximum ovarian follicle diameter

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Ages Eligible for Study: | 18 Years to 38 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | This study is evaluating efficacy of these medications in prevention of ovulation. |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354117
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 |
Responsible Party: | Erica Cahill, Clinical Instructor, Stanford University |
ClinicalTrials.gov Identifier: | NCT03354117 |
Other Study ID Numbers: |
43881 |
First Posted: | November 27, 2017 Key Record Dates |
Last Update Posted: | June 25, 2019 |
Last Verified: | June 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Meloxicam Ulipristal acetate Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents |
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