Complete AbortionPhase 4NCT01387256
Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone
A Phase 4 study testing medical abortion in people with Complete Abortion, run by Gynuity Health Projects at 2 sites in 2 countries.
Trial summary
This double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complete Abortion
- What is being tested?
- medical abortion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2009to Jul 2010
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gestational age < 63 days since LMP, confirmed by ultrasound or clinical assessment.
- General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination.
- Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
- Able to consent to study participation.
Who cannot join
- Gestational age > 63 days LMP
- Confirmed or suspected ectopic or molar pregnancy
- Contraindications to medical abortion including intra-uterine device (IUD) in place (must be removed before procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyries.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone-3 Hour Intervals
This double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the participant.
- Conditions
- Complete Abortion
- Being tested
- medical abortion
- Keywords
- abortion, mifepristone, misoprostol, with gestations > 63 days LMP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical abortionDrug
pregnancy termination with drugs
| Study group | Role | What they receive |
|---|---|---|
| mifepristone+misoprostol | Other | 200 mg mifepristone + 800 mcg buccal misoprostol Receives: Drug: medical abortion |
| buccal misoprostol | Experimental | 2 doses of 800 mcg buccal misoprostol Receives: Drug: medical abortion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women with a complete abortion using study drug alone without recourse to surgical intervention
Number of participants with a complete abortion after treatment without recourse to surgical intervention as a measure of efficacy of the study regimens
Measured: one week from initial treatment
Secondary outcomes (4)
Number of women who indicate that the side effects of buccal misoprostol, administered either alone or in combination with mifepristone, is acceptable in Tunisia and Vietnam
Proportion of women who report the side effects after their treatment to be acceptable as a measure of acceptability with the buccal misoprostol route (with and without mifepristone)
Measured: one week from initial treatment
Evaluate whether women administering buccal misoprostol have a complete abortion with study drug and experience any adverse events, at a rate that is similar to other routes of misoprostol administration
To assess the rate of complete uterine evacuation with study drugs alone and rate of any adverse events among participants after use of buccal misoprostol (alone or with mifepristone)as a measure of its utility in early medical abortion compared to other regimens
Measured: one week from initial treatment
Measuring the proportion of women who report their medical abortion procedure to be acceptable in Tunisia and Vietnam
Proportion of participants reporting that they found the medical abortion regimen assigned to them to be acceptable
Measured: one week from initial treatment
Determining whether women can take both the mifepristone and misoprostol at home on their own by assessing protocol compliance
Proportion of women who report taking mifepristone and misoprostol at home on their own as instructed as a measure of compliance and feasibility of a protocol with at home administration of study drugs
Measured: one week from initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startMay 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387256
- Sponsor's protocol ID
- 1.2.1
- Status last verified
- Jul 2011
- First submitted
- 2 May 2011
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone-3 Hour Intervals
- ClinicalTrials.gov ID
- NCT01387256
- Acronym / sponsor ID
- 1.2.1
- Conditions
- Complete Abortion
- Keywords
- abortion, mifepristone, misoprostol, with gestations > 63 days LMP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 4 Jul 2011 (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 double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mifepristone+misoprostol | Other | Drug: medical abortion200 mg mifepristone + 800 mcg buccal misoprostol |
| buccal misoprostol | Experimental | Drug: medical abortion2 doses of 800 mcg buccal misoprostol |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Gestational age < 63 days since LMP, confirmed by ultrasound or clinical assessment.
- General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination.
- Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
- Able to consent to study participation.
Key exclusion criteria (3 listed)
- Gestational age > 63 days LMP
- Confirmed or suspected ectopic or molar pregnancy
- Contraindications to medical abortion including intra-uterine device (IUD) in place (must be removed before procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyries.
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 |
|---|---|---|
| medical abortionpregnancy termination with drugs | Drug | buccal misoprostol, mifepristone+misoprostol |
Primary outcome
Number of women with a complete abortion using study drug alone without recourse to surgical intervention
Time frame: one week from initial treatment
Number of participants with a complete abortion after treatment without recourse to surgical intervention as a measure of efficacy of the study regimens
4 secondary outcomes
Number of women who indicate that the side effects of buccal misoprostol, administered either alone or in combination with mifepristone, is acceptable in Tunisia and Vietnam
Time frame: one week from initial treatment
Evaluate whether women administering buccal misoprostol have a complete abortion with study drug and experience any adverse events, at a rate that is similar to other routes of misoprostol administration
Time frame: one week from initial treatment
Measuring the proportion of women who report their medical abortion procedure to be acceptable in Tunisia and Vietnam
Time frame: one week from initial treatment
Determining whether women can take both the mifepristone and misoprostol at home on their own by assessing protocol compliance
Time frame: one week from initial treatment
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 20 Jul 2011.
Related trials for Complete Abortion
Active, not recruitingObservational study
Assessment of Early Pregnancy MAB Completion
Pregnancy, Abortion Early
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing medical abortion in people with Complete Abortion, run by Gynuity Health Projects at 2 sites in 2 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 3 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 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia, 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?
Number of women with a complete abortion using study drug alone without recourse to surgical intervention (time frame: one week from initial treatment). 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 20 Jul 2011.