ContraceptionPhase 1NCT03354117
On Demand Contraception: Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility
A Phase 1 study testing Ulipristal Acetate 30 MG Oral Tablet in people with Contraception, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Ulipristal Acetate 30 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 31 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Not currently using or needing hormonal contraception
- Not currently using or needing regular NSAIDS
- Able to commit to frequency of study visits
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: On Demand Contraception: Investigating Efficacy of Ulipristal Acetate Plus a COX-2 Inhibitor 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.
Read the 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.
- Conditions
- Contraception
- Being tested
- Ulipristal Acetate 30 MG Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulipristal Acetate 30 MG Oral TabletDrug
Also called Meloxicam
Each study participant will receive one dose of the study medication (ulipristal acetate 30mg plus meloxicam 15mg) at peak fertility in the treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ulipristal Acetate 30 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks from start of study, approximately
Secondary outcomes (3)
luteal hormone levels
luteal hormone levels
Measured: 8 weeks from start of study, approximately
progesterone hormone levels
progesterone hormone levels
Measured: 8 weeks from start of study, approximately
maximum follicle diameter
maximum ovarian follicle diameter
Measured: 8 weeks from start of study, approximately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start15 Mar 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erica Cahill, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354117
- Sponsor's protocol ID
- 43881
- Status last verified
- Jun 2019
- First submitted
- 21 Nov 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35470225
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On Demand Contraception: Investigating Efficacy of Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility
- ClinicalTrials.gov ID
- NCT03354117
- Acronym / sponsor ID
- 43881
- Conditions
- Contraception
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single, open-label trial of one-time dosing of ulipristal acetate and meloxicam at a peak fertility time point.
| Arm | Type | Receives |
|---|---|---|
| Ulipristal 30mg plus Meloxicam 15mg | Experimental | Drug: Ulipristal Acetate 30 MG Oral TabletEach 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. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Women, aged 18-38
- English speaking
- Able to consent, literate
- Access to smart phone throughout study
- History of regular menses
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulipristal Acetate 30 MG Oral TabletAlso: MeloxicamEach study participant will receive one dose of the study medication (ulipristal acetate 30mg plus meloxicam 15mg) at peak fertility in the treatment cycle. | Drug | Ulipristal 30mg plus Meloxicam 15mg |
Primary outcome
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
3 secondary outcomes
luteal hormone levels
Time frame: 8 weeks from start of study, approximately
progesterone hormone levels
Time frame: 8 weeks from start of study, approximately
maximum follicle diameter
Time frame: 8 weeks from start of study, approximately
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Derived from this study: PubMed 35470225Cahill 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ulipristal Acetate 30 MG Oral Tablet in people with Contraception, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ovulatory disruption (time frame: 8 weeks from start of study, approximately). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03354117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.