Abortion, InducedNCT00870272
Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP)
A study testing Misoprostol in people with Abortion, Induced, run by Gynuity Health Projects at 1 site in Moldova.
Trial summary
This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with misoprostol taken sublingually (under the tongue). 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?
- Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteMoldova
- Study dates
- Jul 2007to Mar 2009
- 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
- Gestational age less than or equal to 63 days
- General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination; and
- Willing to provide an address and/or telephone number for purposes of follow-up.
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of Sublingual and Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with misoprostol taken sublingually (under the tongue). Women presenting for voluntary termination of intrauterine pregnancy with gestational ages of <63 days will be offered the option of participating in the study.
- Conditions
- Abortion, Induced
- Being tested
- Misoprostol
- Keywords
- Medical Abortion, Mifepristone, Misoprostol, Sublingual administration, Buccal administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
400mcg misoprostol taken sublingually or buccally
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 400mcg sublingual misoprostol Receives: Drug: Misoprostol |
| 2 | Active comparator | 400mcg buccal misoprostol Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration
Measured: July 2007-March 2009
Secondary outcomes (1)
Side effects experienced
Measured: July 2007- March 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startJul 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsSheila Raghavan, MSc, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870272
- Sponsor's protocol ID
- 1.2.0
- Status last verified
- Mar 2009
- First submitted
- 26 Mar 2009
- Last updated
- 27 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Sublingual and Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
- ClinicalTrials.gov ID
- NCT00870272
- Acronym / sponsor ID
- 1.2.0
- Conditions
- Abortion, Induced
- Keywords
- Medical Abortion, Mifepristone, Misoprostol, Sublingual administration, Buccal administration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 27 Mar 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, randomized study is being conducted to determine whether a dose of 400 mcg of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with misoprostol taken sublingually (under the tongue). Women presenting for voluntary termination of intrauterine pregnancy with gestational ages of <63 days will be offered the option of participating in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Misoprostol400mcg sublingual misoprostol |
| 2 | Active comparator | Drug: Misoprostol400mcg buccal misoprostol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age less than or equal to 63 days
- General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination; and
- Willing to provide an address and/or telephone number for purposes of follow-up.
Key exclusion criteria (6 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 |
|---|---|---|
| Misoprostol400mcg misoprostol taken sublingually or buccally | Drug | 1, 2 |
Primary outcome
Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration
Time frame: July 2007-March 2009
1 secondary outcome
Side effects experienced
Time frame: July 2007- March 2009
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 27 Mar 2009.
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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
Sheila Raghavan, MSc study director
Gynuity Health Projects
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol in people with Abortion, Induced, run by Gynuity Health Projects at 1 site in Moldova.
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 3 inclusion and 6 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 27 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Moldova. 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?
Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration (time frame: July 2007-March 2009). 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 27 Mar 2009.