Induced AbortionNCT00286208
Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
A study testing Mifepristone, misoprostol in people with Induced Abortion, run by Gynuity Health Projects at 9 sites in 3 countries.
Trial summary
This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Abortion
- What is being tested?
- Mifepristone, misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,443 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Aug 2005to Jan 2008
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women presenting for medical abortion who consent to participate
- Possibility of final gestational age of less than or equal to 63 days
- General good health
- Willing to provide contact information for purposes of follow-up
Who cannot join
- Conditions which contraindicate the use of mifepristone or misoprostol
- Women presenting for medical abortion who do not consent to participate
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Tunisia4 sites
Centre de Planification Familiale de l'Ariana
Aryanah
Centre de Planification Familiale la Bardo
Tunis
Maternité de La Rabta
Tunis
Private clinic
Tunis
Turkey (Türkiye)4 sites
Dr. Zekai Tahir Burak Women's Health Training and Research Hospital
Ankara
MoH Ankara Etlik Maternity and Gyneacological Training Hospital
Ankara
Haydarpaşa Numune Training and Research Hospital Family Planning Clinic
Istanbul
Ege Maternity and Gyneacological Training and Research Hospital
Izmir
About this study
Official title: A Randomized Study of Sublingual Versus Oral 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 sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally.
The goal of this study is to provide answers to the following four questions:
- Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)?
- Are the side effects with sublingual use tolerable for women?
- Is sublingual administration of misoprostol acceptable to women?
- Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?
- Conditions
- Induced Abortion
- Being tested
- Mifepristone, misoprostol
- Keywords
- Medical abortion, mifepristone, misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone, misoprostolDrug
| Study group | Role | What they receive |
|---|---|---|
| Sublingual Misoprostol | Active comparator | 400 mcg of sublingual misoprostol Receives: Drug: Mifepristone, misoprostol |
| Oral Misoprostol | Active comparator | Misoprostol administered orally Receives: Drug: Mifepristone, misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.
Measured: 2 weeks after mifepristone administration
Secondary outcomes (2)
Side effects
Measured: 48 hours
Acceptability for women
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startAug 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheila Raghavan, M.Sc., Study director, Gynuity Health ProjectsBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsRasha Dabash, MPH, Study director, Gynuity Health ProjectsSelma Hajri, MD, Principal investigator, Reproductive Health ConsultantAyse Akin, MD, MPH, Principal investigator, Baskent UniversityIlana Dzuba, MHS, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286208
- Sponsor's protocol ID
- 1.1.5
- Status last verified
- Feb 2014
- First submitted
- 1 Feb 2006
- Last updated
- 19 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
- ClinicalTrials.gov ID
- NCT00286208
- Acronym / sponsor ID
- 1.1.5
- Conditions
- Induced Abortion
- Keywords
- Medical abortion, mifepristone, misoprostol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,443 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 3 Feb 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 is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally.
The goal of this study is to provide answers to the following four questions:
- Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)?
- Are the side effects with sublingual use tolerable for women?
- Is sublingual administration of misoprostol acceptable to women?
- Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual Misoprostol | Active comparator | Drug: Mifepristone, misoprostol400 mcg of sublingual misoprostol |
| Oral Misoprostol | Active comparator | Drug: Mifepristone, misoprostolMisoprostol administered orally |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women presenting for medical abortion who consent to participate
- Possibility of final gestational age of less than or equal to 63 days
- General good health
- Willing to provide contact information for purposes of follow-up
Key exclusion criteria (2 listed)
- Conditions which contraindicate the use of mifepristone or misoprostol
- Women presenting for medical abortion who do not consent to participate
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, misoprostol | Drug | Oral Misoprostol, Sublingual Misoprostol |
Primary outcome
Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.
Time frame: 2 weeks after mifepristone administration
2 secondary outcomes
Side effects
Time frame: 48 hours
Acceptability for women
Time frame: 2 weeks
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 19 Feb 2014.
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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.
Sheila Raghavan, M.Sc. study director
Gynuity Health Projects
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
Rasha Dabash, MPH study director
Gynuity Health Projects
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mifepristone, misoprostol in people with Induced Abortion, run by Gynuity Health Projects at 9 sites in 3 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 4 inclusion and 2 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 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Tunisia, Turkey (Türkiye), 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?
Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15. (time frame: 2 weeks after mifepristone administration). 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 19 Feb 2014.