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Antiprogestin

Mifepristone + 2 doses of misoprostol 800 mcg for Medical Abortion

Phase 4
Waitlist Available
Led By Beverly Winikoff, MD, MPH
Research Sponsored by Gynuity Health Projects
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-14 days after initial visit
Awards & highlights

Study Summary

This trial will test a new medical abortion regimen for women who are 71-84 days pregnant. They will take two doses of a medication (mifepristone and misoprostol) and then be monitored for side effects and efficacy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-14 days after initial visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-14 days after initial visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason
Secondary outcome measures
Proportion of complications experienced by participants that warrant visits to emergency room and/or hospitalization
Proportion of participants who determine method acceptable
Proportion of participants who report each individual side effect

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 78-84 days of gestational ageExperimental Treatment1 Intervention
Pregnant people whose pregnancies are estimated to have a gestational age of 78-84 days.
Group II: 71-77 days of gestational ageActive Control1 Intervention
Pregnant people whose pregnancies are estimated to have a gestational age of 71-77 days. (Participants in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range).

Find a Location

Who is running the clinical trial?

Society of Family PlanningOTHER
98 Previous Clinical Trials
17,111 Total Patients Enrolled
2 Trials studying Medical Abortion
448 Patients Enrolled for Medical Abortion
Gynuity Health ProjectsLead Sponsor
120 Previous Clinical Trials
145,195 Total Patients Enrolled
12 Trials studying Medical Abortion
11,510 Patients Enrolled for Medical Abortion
Beverly Winikoff, MD, MPHPrincipal InvestigatorGynuity Health Projects
47 Previous Clinical Trials
96,263 Total Patients Enrolled
7 Trials studying Medical Abortion
8,119 Patients Enrolled for Medical Abortion

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participation in this clinical research project?

"Indeed, according to clinicaltrials.gov, this study is still seeking patients for enrollment. It was initially announced on October 7th 2022 and underwent its last edit on November 2nd of the same year. The research requires 171 recruits from 8 different medical sites."

Answered by AI

Who is able to enroll in this experiment?

"This investigation seeks 171 individuals for medical abortion care between the ages of 11 and 55. To be considered, patients must: procure services at one of participating clinics; have an intrauterine pregnancy ranging from 71 to 77 days or 78-84 days in gestation; travel back to clinic for follow up appointments; own a mobile phone with messaging capacity; agree to documents confirming consent; abide by all research protocols and post treatment monitoring plans, as well as maintain good physical health."

Answered by AI

What is the current tally of healthcare facilities offering this clinical trial?

"This research is conducted at the University of Hawaii in Honolulu, CHOICES Memphis Center for Reproductive Health located in Tennessee and Planned Parenthood North Central States situated in Saint Paul, Minnesota alongside 8 additional clinical sites."

Answered by AI

Does this research project seek participants who are over fifty years of age?

"This clinical trial stipulates that persons between the ages of 11 and 55 are eligible to apply. Separately, 4 studies for younger applicants aged 18 years or below and 12 trials accommodating elderly patients who exceed 65 have been established."

Answered by AI

Are there any historical accounts of Mifepristone + 2 doses of misoprostol 800 mcg being studied in a clinical capacity?

"Mifepristone combined with two doses of misoprostol 800 mcg was initially investigated at Ain Shams Maternity hospital in 2014. Subsequently, a total of 279 studies have concluded and 27 more are actively recruiting participants, the majority being located in Honolulu, Hawaii."

Answered by AI

Is this research study currently open to recruitment?

"Affirmative. According to the information located on clinicaltrials.gov, this medical trial is actively seeking participants. The study was initially published on October 7th 2022 and last edited November 2nd 2022; in total it needs 171 patients from 8 different locations."

Answered by AI

What is the intended purpose of utilizing Mifepristone in conjunction with two doses of misoprostol 800 mcg?

"Mifepristone + 2 doses of misoprostol 800 mcg is typically employed to induce labor, but also has applications in the treatment of cushing syndrome, medical procedures and postpartum hemorrhage."

Answered by AI

Is the Mifepristone + 2 doses of misoprostol 800 mcg regimen sanctioned by the FDA?

"The safety of Mifepristone + 2 doses of misoprostol 800 mcg has been established and is noted with a 3 on the risk scale. This drug combination currently holds approval status due to its phase 4 trial data."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Mifepristone and Two Doses of Misoprostol for Abortion at 11&12 Weeks
2022. "Mifepristone and Two Doses of Misoprostol for Abortion at 11&12 Weeks". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05119439.
~9 spots leftby Apr 2025
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