Medical AbortionPhase 4NCT05119439
Mifepristone and Two Doses of Misoprostol for Abortion at 11&12 Weeks
A Phase 4 study testing Mifepristone + 2 doses of misoprostol 800 mcg in people with Medical Abortion, run by Gynuity Health Projects at 6 sites in United States.
Trial summary
This study seeks to evaluate the efficacy, side effect profile and acceptability of a medical abortion regimen with mifepristone and two doses of 800 mcg misoprostol buccally at 71-77 and 78-84 days of gestation to further expand the evidence base for the most effective regimens in the late first trimester of… Read more about this study
- Who is it for?
- Ages 11 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Abortion
- What is being tested?
- Mifepristone + 2 doses of misoprostol 800 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 6 sitesUnited States
- Study dates
- 7 Oct 2022to 30 Jun 2023
- Phase
- Phase 4
- 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 11 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Seeking medical abortion services at one of the enrolling clinics
- Have an intrauterine pregnancy 71-77 days of gestation or 78-84 days
- Meet standard eligibility criteria for medical abortion
- Be able to return to clinic for in-person follow up
- Speak/read/write English or Spanish
- Have access to a mobile phone with texting capability
Show all 9Show fewer
- Be in general good health
- Be willing and able to sign consent forms
- Agree to comply with the study procedures and follow up.
Who cannot join
- Not eligible to consent on their own to being in a study (Age criteria may vary by site according to state law.)
- With known allergies or other contraindications to mifepristone or misoprostol
- Desiring to start depot medroxyprogesterone acetate (DMPA) as contraception method immediately because of potential interaction with mifepristone. Those who wish to wait until abortion completion to start DMPA will be eligible for enrollment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky
Federal Way, Washington, 98003
University of Hawaii
Hilo, Hawaii, 96720
University of Hawaii
Honolulu, Hawaii, 96822
Philadelphia Women's Center
Philadelphia, Pennsylvania, 19106
Planned Parenthood North Central States
Saint Paul, Minnesota, 55114
Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky
Tacoma, Washington, 98405
About this study
Official title: An Outpatient Medical Abortion Regimen With Mifepristone and Two Doses of Misoprostol at 71-77 and 78-84 Days of Pregnancy
This study seeks to evaluate the efficacy, side effect profile and acceptability of a medical abortion regimen with mifepristone and two doses of 800 mcg misoprostol buccally at 71-77 and 78-84 days of gestation to further expand the evidence base for the most effective regimens in the late first trimester of pregnancy.
- Conditions
- Medical Abortion
- Being tested
- Mifepristone + 2 doses of misoprostol 800 mcg
- Keywords
- mifepristone, misoprostol, first trimester, abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone + 2 doses of misoprostol 800 mcgDrug
Will use a mifepristone-misoprostol regimen of: 200 mg mifepristone followed in 24-48 hours by a first dose of 800 µg misoprostol buccally and then in another 4 hours by a second dose of 800 µg misoprostol buccally. For buccal administration of misoprostol, participants will place 2 misoprostol tablets in each cheek and hold them for 20-30 minutes, after which they will swallow any remnants.
| Study group | Role | What they receive |
|---|---|---|
| 71-77 days of gestational age | No 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). |
| 78-84 days of gestational age | Experimental | Pregnant people whose pregnancies are estimated to have a gestational age of 78-84 days. Receives: Drug: Mifepristone + 2 doses of misoprostol 800 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason
Proportion of women who achieve complete abortion with medication only and without aspiration or D\&E
Measured: 7-36 days after initial visit
Secondary outcomes (3)
Proportion of participants who report each individual side effect
Side effects include diarrhea, nausea, vomiting, fever, chills
Measured: 7-14 days after initial visit
Proportion of complications experienced by participants that warrant visits to emergency room and/or hospitalization
Complications could include abnormal bleeding, severe pain, retained tissue
Measured: 7-14 days after initial visit
Proportion of participants who determine method acceptable
Overall acceptability, time to complete abortion, bleeding, side effects, pain
Measured: 7-36 days after initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start7 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Why it stopped: Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical AbortionStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119439
- Sponsor's protocol ID
- 1050
- Status last verified
- Jul 2023
- First submitted
- 5 Nov 2021
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Outpatient Medical Abortion Regimen With Mifepristone and Two Doses of Misoprostol at 71-77 and 78-84 Days of Pregnancy
- ClinicalTrials.gov ID
- NCT05119439
- Acronym / sponsor ID
- 1050
- Conditions
- Medical Abortion
- Keywords
- mifepristone, misoprostol, first trimester, abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 15 Nov 2021 (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 study seeks to evaluate the efficacy, side effect profile and acceptability of a medical abortion regimen with mifepristone and two doses of 800 mcg misoprostol buccally at 71-77 and 78-84 days of gestation to further expand the evidence base for the most effective regimens in the late first trimester of pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 71-77 days of gestational age | No 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). |
| 78-84 days of gestational age | Experimental | Drug: Mifepristone + 2 doses of misoprostol 800 mcgPregnant people whose pregnancies are estimated to have a gestational age of 78-84 days. |
Who may qualify
- Ages
- 11 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Seeking medical abortion services at one of the enrolling clinics
- Have an intrauterine pregnancy 71-77 days of gestation or 78-84 days
- Meet standard eligibility criteria for medical abortion
- Be able to return to clinic for in-person follow up
- Speak/read/write English or Spanish
Key exclusion criteria (3 listed)
- Not eligible to consent on their own to being in a study (Age criteria may vary by site according to state law.)
- With known allergies or other contraindications to mifepristone or misoprostol
- Desiring to start depot medroxyprogesterone acetate (DMPA) as contraception method immediately because of potential interaction with mifepristone. Those who wish to wait until abortion completion to start DMPA will be eligible for enrollment.
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 |
|---|---|---|
| Mifepristone + 2 doses of misoprostol 800 mcgWill use a mifepristone-misoprostol regimen of: 200 mg mifepristone followed in 24-48 hours by a first dose of 800 µg misoprostol buccally and then in another 4 hours by a second dose of 800 µg misoprostol buccally. For buccal administration of misoprostol, participants will place 2 misoprostol tablets in each cheek and hold them for 20-30 minutes, after which they will swallow any remnants. | Drug | 78-84 days of gestational age |
Primary outcome
Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason
Time frame: 7-36 days after initial visit
Proportion of women who achieve complete abortion with medication only and without aspiration or D\&E
3 secondary outcomes
Proportion of participants who report each individual side effect
Time frame: 7-14 days after initial visit
Proportion of complications experienced by participants that warrant visits to emergency room and/or hospitalization
Time frame: 7-14 days after initial visit
Proportion of participants who determine method acceptable
Time frame: 7-36 days after initial visit
Results and safety
The study was stopped early (reason given: Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
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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.
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mifepristone + 2 doses of misoprostol 800 mcg in people with Medical Abortion, run by Gynuity Health Projects at 6 sites 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 3 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 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Enrollment). Results are not available in the source record.
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?
Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason (time frame: 7-36 days after initial visit). 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 25 Jul 2023.