Medical AbortionPhase 4XXGANCT02314754
Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation
A Phase 4 study testing Mifepristone followed by misoprostol 24-48 hours later in people with Medical Abortion, run by Gynuity Health Projects at 8 sites in 5 countries.
Trial summary
To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48 hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77 days' compared to women 64-70 days' LMP. 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 followed by misoprostol 24-48 hours later
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 719 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Dec 2014to Apr 2016
- 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
- intrauterine pregnancy between 64 days and 77 days' LMP
- eligible for medical abortion according to study doctor assessment
- willing and able to sign consent form
- speak english or spanish (in US sites); speak the local language(s) (in international sites)
- agree to comply with the study procedures and visit schedule
Who cannot join
- Have known allergies or present other contraindications to mifepristone or misoprostol
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
United States4 sites
Atlanta Women's Center
Atlanta, Georgia, 30342
John H. Stroger, Jr. Hospital of Cook CountY
Chicago, Illinois, 60612
Family Planning Associates Medical Group
Chicago, Illinois, 60630
Hartford GYN Center
Hartford, Connecticut, 06106
Azerbaijan1 site
Scientific Research Institute of Obstetrics and Gynecology
Baku
About this study
Official title: Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation: A Non-inferiority Trial
To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48 hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77 days' compared to women 64-70 days' LMP.
- Conditions
- Medical Abortion
- Being tested
- Mifepristone followed by misoprostol 24-48 hours later
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone followed by misoprostol 24-48 hours laterDrug
200mg oral mifepristone and 800mcg buccal misoprostol 24-48 hours after mifepristone
| Study group | Role | What they receive |
|---|---|---|
| 71-77 days gestational age | Experimental | Women whose pregnancies are estimated to have a gestational age of 71-77 days. Receives: Drug: Mifepristone followed by misoprostol 24-48 hours later |
| 64-70 days gestational age | No intervention | Women whose pregnancies are estimated to have a gestational age of 64-70 days.( Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range). |
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 terminations without surgical intervention (suction curettage or D&C) for any reason
Efficacy of medical abortion in the later first trimester as determined by the proportion of successful terminations without surgical intervention (suction curettage or D\&C) for any reason
Measured: 7-36 days
Secondary outcomes (3)
Proportion of Individual Side Effects Experienced by Participants
Side effects include diarrhea, nausea, vomiting, fever, chills, headaches, dizziness and/or weakness experienced by participants
Measured: 7-14 days
Proportion of Women Who Determine Method Acceptable
overall acceptability, time to complete abortion, bleeding, side effects, pain
Measured: 7-14 days
Proportion of Providers Who Determine Method Acceptable
As assessed by service provider semi-structured interviews
Measured: 7-36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2016
- Study completionApr 2016
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
- 719 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD,MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314754
- Sponsor's protocol ID
- 1016
- Acronym
- XXGA
- Status last verified
- Jul 2016
- First submitted
- 4 Dec 2014
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation: A Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02314754
- Acronym / sponsor ID
- XXGA / 1016
- Conditions
- Medical Abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 719 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Dec 2014 (estimated)
- 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.
To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48 hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77 days' compared to women 64-70 days' LMP.
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 gestational age | Experimental | Drug: Mifepristone followed by misoprostol 24-48 hours laterWomen whose pregnancies are estimated to have a gestational age of 71-77 days. |
| 64-70 days gestational age | No intervention | –Women whose pregnancies are estimated to have a gestational age of 64-70 days.( Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range). |
Who may qualify
- Ages
- 11 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- intrauterine pregnancy between 64 days and 77 days' LMP
- eligible for medical abortion according to study doctor assessment
- willing and able to sign consent form
- speak english or spanish (in US sites); speak the local language(s) (in international sites)
- agree to comply with the study procedures and visit schedule
Key exclusion criteria (1 listed)
- Have known allergies or present other contraindications to mifepristone or misoprostol
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 followed by misoprostol 24-48 hours later200mg oral mifepristone and 800mcg buccal misoprostol 24-48 hours after mifepristone | Drug | 71-77 days gestational age |
Primary outcome
Efficacy as determined by the proportion of successful terminations without surgical intervention (suction curettage or D&C) for any reason
Time frame: 7-36 days
Efficacy of medical abortion in the later first trimester as determined by the proportion of successful terminations without surgical intervention (suction curettage or D\&C) for any reason
3 secondary outcomes
Proportion of Individual Side Effects Experienced by Participants
Time frame: 7-14 days
Proportion of Women Who Determine Method Acceptable
Time frame: 7-14 days
Proportion of Providers Who Determine Method Acceptable
Time frame: 7-36 days
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 14 Jul 2016.
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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
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mifepristone followed by misoprostol 24-48 hours later in people with Medical Abortion, run by Gynuity Health Projects at 8 sites in 5 countries.
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 5 inclusion and 1 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 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Azerbaijan, Georgia, Mexico, Vietnam. 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 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?
Efficacy as determined by the proportion of successful terminations without surgical intervention (suction curettage or D&C) for any reason (time frame: 7-36 days). 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 14 Jul 2016.