NauseaEarly Phase 1NCT05819619
Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days
A Early Phase 1 study testing Prophylactic use of ibuprofen and ondansetron post misoprostol administration and Use of ibuprofen and ondansetron at symptom onset post misoprostol administration in people with Nausea and Pain, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
Randomized trial which will aim to evaluate whether prophylactic use of ondansetron and ibuprofen will decrease side effects associated with medical abortion and increase patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- What is being tested?
- Prophylactic use of ibuprofen and ondansetron post misoprostol administration and Use of ibuprofen and ondansetron at symptom onset post misoprostol administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2023to 11 Apr 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- English speaking
- female volunteers undergoing medical abortion whether for voluntary interruption of pregnancy or missed abortion
- Gestational age </= 70 days confirmed via ultrasound
- Access to a time keeping device
- Willingness to complete a telephone or in-clinic follow up
Who cannot join
- chronic medical problems including but not limited to cardiac conditions, malignancy or organ damage
- Failed medical abortion resulting in surgical management
- Known intrauterine infection
- Known allergy to ondansetron or ibuprofen
- Subjects chronically receiving analgesic drugs
- Subjects unable to give consent
- Subjects taking medications that interact with ondansetron or ibuprofen
Trial locations and contacts
1 site in 1 country.
About this study
Randomized trial which will aim to evaluate whether prophylactic use of ondansetron and ibuprofen will decrease side effects associated with medical abortion and increase patient satisfaction.
- Being tested
- Prophylactic use of ibuprofen and ondansetron post misoprostol administration, Use of ibuprofen and ondansetron at symptom onset post misoprostol administration
- Keywords
- medical abortion, prophylactic use, nausea, pain, patient satisfaction
- Medical subject headings
- Nausea, Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic use of ibuprofen and ondansetron post misoprostol administrationDrug
Prophylactic use of ibuprofen and ondansetron post misoprostol administration
Use of ibuprofen and ondansetron at symptom onset post misoprostol administrationDrug
Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration. Receives: Drug: Use of ibuprofen and ondansetron at symptom onset post misoprostol administration |
| Prophylactic use | Experimental | Administration of ibuprofen and ondansetron at the time of misoprostol administration. Receives: Drug: Prophylactic use of ibuprofen and ondansetron post misoprostol administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction thereby creating a more favorable outcome.
Patient satisfaction will be assessed using a home developed survey. Satisfaction is measured on 5-Likert scale ranging from Very satisfied to Very dissatisfied.
Measured: At follow up visit, within 2 weeks from the administration of misoprostol
Patient Satisfaction Based on Recommendation of Regimen
Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction based on their likelihood to recommend the regimen.
Likelihood to recommend will be assessed using a home developed survey measured on 5-Likert scale ranging from "Extremely likely to recommend" to "Extremely unlikely to recommend" (an additional "I do not know option" will be provided).
Measured: At follow up visit, within 2 weeks from the administration of misoprostol
Secondary outcomes (6)
Pain Management at 6-8 Hours
Evaluate for a satisfactory pain management regimen for medical abortion using a numerical pain scale ranging from 1 to 10 with 1 being "no pain" and 10 being "very much pain".
Measured: Within 6-8 hours from the administration of misoprostol
Pain Management at 24 Hours
Evaluate for a satisfactory pain management regimen for medical abortion using a numerical pain scale ranging from 1 to 10 with 1 being "no pain" and 10 being "very much pain".
Measured: Within 24 hours from the administration of misoprostol
Nausea Management
Evaluate for a satisfactory anti-nausea management regimen for medical abortion using a numerical nausea scale ranging from 1 to 10 with 1 being "no nausea" and 10 being "very much nausea".
Measured: Within 6-8 hours from the administration of misoprostol
Nausea Management
Evaluate for a satisfactory anti-nausea management regimen for medical abortion using a numerical nausea scale ranging from 1 to 10 with 1 being "no nausea" and 10 being "very much nausea".
Measured: Within 24 hours from the administration of misoprostol
Need for Pain Management Medication.
Evaluate for a satisfactory pain management regimen for medical abortion based on the need for additional pain medication (Yes vs. No).
Measured: Within 24 hours from the administration of misoprostol
Need for Anti-nausea Medication.
Evaluate for a satisfactory anti-nausea management regimen for medical abortion based on the additional anti-nausea medication (Yes vs. No).
Measured: Within 24 hours from the administration of misoprostol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start20 Jul 2023
- Primary completion1 Apr 2024
- Study completion11 Apr 2024
Why it stopped: Inability to recruit and staffing changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NauseaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Figueroa, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819619
- Sponsor's protocol ID
- Pro2021-1405
- Status last verified
- Nov 2025
- First submitted
- 15 Mar 2023
- Last updated
- 17 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days
- ClinicalTrials.gov ID
- NCT05819619
- Acronym / sponsor ID
- Pro2021-1405
- Keywords
- medical abortion, prophylactic use, nausea, pain, patient satisfaction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit and staffing changes
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Posted 17 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized trial which will aim to evaluate whether prophylactic use of ondansetron and ibuprofen will decrease side effects associated with medical abortion and increase patient satisfaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Drug: Use of ibuprofen and ondansetron at symptom onset post misoprostol administrationAdministration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration. |
| Prophylactic use | Experimental | Drug: Prophylactic use of ibuprofen and ondansetron post misoprostol administrationAdministration of ibuprofen and ondansetron at the time of misoprostol administration. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy
- English speaking
- female volunteers undergoing medical abortion whether for voluntary interruption of pregnancy or missed abortion
- Gestational age </= 70 days confirmed via ultrasound
- Access to a time keeping device
Key exclusion criteria (7 listed)
- chronic medical problems including but not limited to cardiac conditions, malignancy or organ damage
- Failed medical abortion resulting in surgical management
- Known intrauterine infection
- Known allergy to ondansetron or ibuprofen
- Subjects chronically receiving analgesic drugs
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 |
|---|---|---|
| Prophylactic use of ibuprofen and ondansetron post misoprostol administrationProphylactic use of ibuprofen and ondansetron post misoprostol administration | Drug | Prophylactic use |
| Use of ibuprofen and ondansetron at symptom onset post misoprostol administrationAdministration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration. | Drug | Standard of care |
Primary outcome
Patient Satisfaction
Time frame: At follow up visit, within 2 weeks from the administration of misoprostol
Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction thereby creating a more favorable outcome. Patient satisfaction will be assessed using a home developed survey. Satisfaction is measured on 5-Likert scale ranging from Very satisfied to Very dissatisfied.
Patient Satisfaction Based on Recommendation of Regimen
Time frame: At follow up visit, within 2 weeks from the administration of misoprostol
Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction based on their likelihood to recommend the regimen. Likelihood to recommend will be assessed using a home developed survey measured on 5-Likert scale ranging from "Extremely likely to recommend" to "Extremely unlikely to recommend" (an additional "I do not know option" will be provided).
6 secondary outcomes
Pain Management at 6-8 Hours
Time frame: Within 6-8 hours from the administration of misoprostol
Pain Management at 24 Hours
Time frame: Within 24 hours from the administration of misoprostol
Nausea Management
Time frame: Within 6-8 hours from the administration of misoprostol
Nausea Management
Time frame: Within 24 hours from the administration of misoprostol
Need for Pain Management Medication.
Time frame: Within 24 hours from the administration of misoprostol
Need for Anti-nausea Medication.
Time frame: Within 24 hours from the administration of misoprostol
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Melissa Figueroa, MD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Prophylactic use of ibuprofen and ondansetron post misoprostol administration and Use of ibuprofen and ondansetron at symptom onset post misoprostol administration in people with Nausea and Pain, run by Hackensack Meridian Health 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 6 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: stopped early, as of the sponsor's last update on 17 Nov 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Satisfaction (time frame: At follow up visit, within 2 weeks from the administration of misoprostol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2025.