Medical AbortionPhase 4NCT00997347
The Extended Gestational Age Medical Abortion Study
A Phase 4 study testing Mifepristone and misoprostol in people with Medical Abortion, run by Gynuity Health Projects at 12 sites in 5 countries.
Trial summary
This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Abortion
- What is being tested?
- Mifepristone and misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Jul 2009to Feb 2012
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- intrauterine pregnancy of greater than 56 days and less than 71 days
- eligible for medical abortion according to study doctor assessment
- willing and able to sign consent forms
- 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
None listed.
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
United States6 sites
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215
Family Planning Associates Medical Group
Chicago, Illinois, 60630
Planned Parenthood of New York City
New York, New York, 10012
Planned Parenthood, Minnesota, North Dakota, South Dakota
Saint Paul, Minnesota, 55116
Planned Parenthood, Central Texas
Waco, Texas, 76710
Presidential Women's Center
West Palm Beach, Florida, 33407
Ukraine2 sites
Central District Maternity House
Odesa
Maternity Hospital No.2
Simferopol
About this study
Official title: The Extended Gestational Age Medical Abortion Study: The Effectiveness of Medical Abortion With Mifepristone and Misoprostol at 57-63 Days Versus 64-70 Days Gestation
This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.
- Conditions
- Medical Abortion
- Being tested
- Mifepristone and misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone and misoprostolDrug
200 mg oral mifepristone
800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone
| Study group | Role | What they receive |
|---|---|---|
| 64-70 days' gestational age | Experimental | Women whose pregnancies are estimated to have a gestational age of 64-70 days Receives: Drug: Mifepristone and misoprostol |
| 57-63 days' gestational age | No intervention | Women whose pregnancies are estimated to have a gestational age of 57-63 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: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion
Measured: 7-36 days
Secondary outcomes (4)
Proportion of individual side effects experienced by participants
Measured: 7-14 days
Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain)
Measured: 7-14 days
Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began
Measured: 7-14 days
Average number of missed days of work or school due to the abortion procedure
Measured: 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yael Swica, MD, MPH, Principal investigator, Gynuity Health ProjectsHillary Bracken, PhD, Principal investigator, Gynuity Health ProjectsBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997347
- Sponsor's protocol ID
- 1.2.2
- Status last verified
- Jun 2012
- First submitted
- 1 Oct 2009
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Winikoff B, Dzuba IG, Chong E, Goldberg AB, Lichtenberg ES, Ball C, Dean G, Sacks D, Crowden WA, Swica Y. Extending outpatient medical abortion services through 70 days of gestational age. Obstet Gynecol. 2012 Nov;120(5):1070-6. doi: 10.1097/aog.0b013e31826c315f.
PubMed 23090524
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Extended Gestational Age Medical Abortion Study: The Effectiveness of Medical Abortion With Mifepristone and Misoprostol at 57-63 Days Versus 64-70 Days Gestation
- ClinicalTrials.gov ID
- NCT00997347
- Acronym / sponsor ID
- 1.2.2
- Conditions
- Medical Abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Oct 2009 (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.
This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 64-70 days' gestational age | Experimental | Drug: Mifepristone and misoprostolWomen whose pregnancies are estimated to have a gestational age of 64-70 days |
| 57-63 days' gestational age | No intervention | –Women whose pregnancies are estimated to have a gestational age of 57-63 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
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- intrauterine pregnancy of greater than 56 days and less than 71 days
- eligible for medical abortion according to study doctor assessment
- willing and able to sign consent forms
- 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 (0 listed)
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 and misoprostol200 mg oral mifepristone 800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone | Drug | 64-70 days' gestational age |
Primary outcome
Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion
Time frame: 7-36 days
4 secondary outcomes
Proportion of individual side effects experienced by participants
Time frame: 7-14 days
Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain)
Time frame: 7-14 days
Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began
Time frame: 7-14 days
Average number of missed days of work or school due to the abortion procedure
Time frame: 7-14 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 2 Jul 2012.
- Derived from this study: PubMed 23090524Winikoff B, Dzuba IG, Chong E, Goldberg AB, Lichtenberg ES, Ball C, Dean G, Sacks D, Crowden WA, Swica Y. Extending outpatient medical abortion services through 70 days of gestational age. Obstet Gynecol. 2012 Nov;120(5):1070-6. doi: 10.1097/aog.0b013e31826c315f.
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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.
Yael Swica, MD, MPH principal investigator
Gynuity Health Projects
Hillary Bracken, PhD principal investigator
Gynuity Health Projects
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
12 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 and misoprostol in people with Medical Abortion, run by Gynuity Health Projects at 12 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 0 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 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, India, Ukraine, Georgia, Tunisia. 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: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion (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?
On the ClinicalTrials.gov record for NCT00997347, which also lists 1 linked publication.
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 2 Jul 2012.