Abortion, InducedNCT00386867
A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP
A study testing 800 mcg misoprostol via oral or buccal administration in people with Abortion, Induced, run by Gynuity Health Projects at 8 sites in United States.
Trial summary
This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P. 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
- Abortion, Induced
- What is being tested?
- 800 mcg misoprostol via oral or buccal administration
- Type of treatment
- Pill or oral medicine
- How many people
- 1,200 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2006to Mar 2007
- Phase
- Interventional
- 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
- be willing and able to sign consent forms;
- be eligible for medical abortion according to clinician's assessment;
- be willing to undergo a surgical completion if necessary;
- have ready and easy access to a telephone and emergency transportation;
- speak English, Spanish, or have a translator available to translate for all study procedures; and,
- agree to comply with the study procedures and visit schedule.
Who cannot join
- Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
- IUD in place;
- Chronic renal failure;
- Concurrent long-term corticosteroid therapy;
- History of allergy to mifepristone, misoprostol or other prostaglandin;
- Hemorrhagic disorders or concurrent anticoagulant therapy;
- Inherited porphyrias; or
- Other serious physical or mental health conditions.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Whole Women's Health
Austin, Texas
Planned Parenthood League of Massachusetts (Boston clinic)
Boston, Massachusetts
Family Planning Associates Medical Group
Chicago, Illinois
Columbia University Medical Center, Division of Obstetrics & Gynecology
New York, New York
Institute for Urban Family Health
New York, New York
Parkmed
New York, New York
University of Pittsburgh, Division of Obstetrics, Gynecology and Reproductive Sciences
Pittsburgh, Pennsylvania
Planned Parenthood
Waco, Texas
About this study
This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.
- Conditions
- Abortion, Induced
- Being tested
- 800 mcg misoprostol via oral or buccal administration
- Keywords
- medical abortion, mifepristone, misoprostol, buccal administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
800 mcg misoprostol via oral or buccal administrationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy
Secondary outcomes (1)
acceptability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startOct 2006
- Study completionMar 2007
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 Abortion, InducedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsIlana Dzuba, MHS, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386867
- Sponsor's protocol ID
- 1.1.3
- Status last verified
- Jun 2007
- First submitted
- 10 Oct 2006
- Last updated
- 5 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Winikoff B, Dzuba IG, Creinin MD, Crowden WA, Goldberg AB, Gonzales J, Howe M, Moskowitz J, Prine L, Shannon CS. Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstet Gynecol. 2008 Dec;112(6):1303-1310. doi: 10.1097/AOG.0b013e31818d8eb4.
PubMed 19037040
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP
- ClinicalTrials.gov ID
- NCT00386867
- Acronym / sponsor ID
- 1.1.3
- Conditions
- Abortion, Induced
- Keywords
- medical abortion, mifepristone, misoprostol, buccal administration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Mar 2007
- First posted
- 12 Oct 2006 (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, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be willing and able to sign consent forms;
- be eligible for medical abortion according to clinician's assessment;
- be willing to undergo a surgical completion if necessary;
- have ready and easy access to a telephone and emergency transportation;
- speak English, Spanish, or have a translator available to translate for all study procedures; and,
Key exclusion criteria (8 listed)
- Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
- IUD in place;
- Chronic renal failure;
- Concurrent long-term corticosteroid therapy;
- History of allergy to mifepristone, misoprostol or other prostaglandin;
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 |
|---|---|---|
| 800 mcg misoprostol via oral or buccal administration | Drug | – |
Primary outcome
efficacy
1 secondary outcome
acceptability
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 5 Jun 2007.
- Derived from this study: PubMed 19037040Winikoff B, Dzuba IG, Creinin MD, Crowden WA, Goldberg AB, Gonzales J, Howe M, Moskowitz J, Prine L, Shannon CS. Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstet Gynecol. 2008 Dec;112(6):1303-1310. doi: 10.1097/AOG.0b013e31818d8eb4.
- Related InfoLink provided by the sponsor.
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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
Ilana Dzuba, MHS study director
Gynuity Health Projects
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 800 mcg misoprostol via oral or buccal administration in people with Abortion, Induced, run by Gynuity Health Projects at 8 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 6 inclusion and 8 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 5 Jun 2007. 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. 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.
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. 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 NCT00386867, 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 5 Jun 2007.