Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

NCT05819619 | Terminated Early Phase 1 Results FDA Drug

• 1 other identifier: Pro2021-1405
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nausea; Pain

Keywords

medical abortion; prophylactic use; nausea; pain; patient satisfaction

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  At follow up visit, within 2 weeks from the administration of misoprostol

Secondary Outcomes (6)

• Pain Management at 6-8 Hours

  Within 6-8 hours from the administration of misoprostol

• Pain Management at 24 Hours

  Within 24 hours from the administration of misoprostol

• Nausea Management

  Within 6-8 hours from the administration of misoprostol

• Nausea Management

  Within 24 hours from the administration of misoprostol

• Need for Pain Management Medication.

  Within 24 hours from the administration of misoprostol

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.

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.

Drug: Prophylactic use of ibuprofen and ondansetron post misoprostol administration

Interventions

Prophylactic use of ibuprofen and ondansetron post misoprostol administration DRUG

Prophylactic use of ibuprofen and ondansetron post misoprostol administration

Prophylactic use

Use of ibuprofen and ondansetron at symptom onset post misoprostol administration DRUG

Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.

Standard of care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Antonia Oladipo

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Nausea; Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Melissa M. Figueroa, MD, MPH, FACOG
• Organization: Hackensack Meridian Health

melissa.figueroa@hmhn.org

551-996-8400

Study Officials

• Melissa Figueroa, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 19, 2023
• Study Start: July 20, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 11, 2024
• Last Updated: November 17, 2025
• Results First Posted: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)