Pregnancy TerminationNCT00680394
Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone
A study testing mifepristone and misoprostol in people with Pregnancy Termination, run by Gynuity Health Projects at 2 sites in 2 countries.
Trial summary
A double blinded, placebo-controlled randomized trial to compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days' LMP. 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
- Pregnancy Termination
- What is being tested?
- mifepristone and misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2007to May 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
- Gestational age < 63 days by LMP, 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
- Confirmed or suspected ectopic or molar pregnancy
- Contraindications to medical abortion including 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
A double blinded, placebo-controlled randomized trial to compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days' LMP. 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. We hypthesize that both methods work well, but that the mifepristone regimen will have an efficacy rate of approximately 95%, and misoprostol alone will be closer to 90%. We will consider a greater than 5% difference to be clinically meaningful.
Read the detailed description
Non-surgical abortion methods have the potential to improve the quality and safety of women's reproductive health in the developing world. However, until recently, widespread availability and utilization of medical abortion with mifepristone in low resource countries has been restricted by the limited availability of mifepristone and perceived high cost of the drug, while the low and varied rates of efficacy of the misoprostol alone regimens have hindered its widespread adoption. In recent years, a handful of new mifepristone and misoprostol products have come to the market, easing the availability and reducing the cost of both drugs, and therefore making their introduction in new settings more feasible. Nonetheless, mifepristone is much more expensive than misoprostol (approximately $4 - 6 a tablet versus $0.35 a tablet) and often a large part of the cost of the medical abortion cost. In this respect, this study provides an important opportunity to better understand the real difference in efficacy of the two regimens in addition to the costs and benefits of these two non-surgical abortion regimens.
The study will contribute greatly to the literature on medical abortion. First, it will be the first randomized trial to compare two buccal regimens (and the second ever to compare mifepristone+misoprostol with misoprostol alone. Second, if proven efficacious, it promises to offer alternative regimens for use in women with gestations up to 63 days' LMP. Third, it may create evidence in support of shortening the time to abortion completion, by offering all women in the mifepristone arm the chance to complete their abortions 24 hours after mifepristone, instead of the standard 48 hours later. Lastly, it provides a unique opportunity to systematically and in a non-biased manner, compare the side effects and acceptability of these two regimens, thereby creating more information to help providers and policy makers debate the relative costs and benefits of these two medical abortion regimens.
A total of 700 women will be recruited. We assume that the efficacy of mifepristone plus buccal misoprostol is approximately 95%. The efficacy of misoprostol alone for medical abortion, via the vaginal route, is 88%. The efficacy of misoprostol alone via the buccal route is not known, nor is the efficacy via the buccal route with repeat dosing after a 24 hour interval. We expect that the efficacy with buccal misoprostol should be similar to that with vaginal misoprostol based on both pharmokinetic and clinical data.
We assume that the efficacy of mifepristone plus buccal misoprostol in our research settings will be 95%. A difference in efficacy of buccal misoprostol alone of at least 5% (90%) is clinically meaningful to providers and women.
Using alpha = 0.05 with a one-sided test and power = 0.80, the number needed to demonstrate this difference is 664 (334 in each arm). Assuming 5% will drop out or not complete the protocol, we plan to enroll a total of 700 women.
The primary endpoint is efficacy; safety, acceptability and side effects will be assessed as secondary endpoints.
- Conditions
- Pregnancy Termination
- Being tested
- mifepristone, misoprostol, placebo
- Keywords
- abortion, medical abortion, mifepristone, misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mifepristoneDrug
200 mg mifepristone
misoprostolDrug
800 buccal misoprostol + matching placebo or 1600 buccal misoprostol
placeboDrug
800 buccal misoprostol + matching placebo or 1600 buccal misoprostol
| Study group | Role | What they receive |
|---|---|---|
| mifepristone+misoprostol | Experimental | 200 mg mifepristone+ 800 mcg buccal misoprostol Receives: Drug: mifepristone; Drug: misoprostol |
| misoprostol | Experimental | 800 mcg buccal misoprostol+placebo Receives: Drug: misoprostol; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy defined as complete abortion without recourse to surgical abortion.
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 posted20 May 2008 (estimated)
- Study startJul 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy TerminationStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680394
- Sponsor's protocol ID
- Protocol 1.2.1
- Status last verified
- Mar 2013
- First submitted
- 3 Mar 2008
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Blum J, Raghavan S, Dabash R, Ngoc Nt, Chelli H, Hajri S, Conkling K, Winikoff B. Comparison of misoprostol-only and combined mifepristone-misoprostol regimens for home-based early medical abortion in Tunisia and Vietnam. Int J Gynaecol Obstet. 2012 Aug;118(2):166-71. doi: 10.1016/j.ijgo.2012.03.039. Epub 2012 Jun 8.
PubMed 22682768Ngoc NT, Blum J, Raghavan S, Nga NT, Dabash R, Diop A, Winikoff B. Comparing two early medical abortion regimens: mifepristone+misoprostol vs. misoprostol alone. Contraception. 2011 May;83(5):410-7. doi: 10.1016/j.contraception.2010.09.002. Epub 2010 Oct 18.
PubMed 21477682
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. 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
- ClinicalTrials.gov ID
- NCT00680394
- Acronym / sponsor ID
- Protocol 1.2.1
- Conditions
- Pregnancy Termination
- Keywords
- abortion, medical abortion, mifepristone, misoprostol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 20 May 2008 (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.
A double blinded, placebo-controlled randomized trial to compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days' LMP. 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. We hypthesize that both methods work well, but that the mifepristone regimen will have an efficacy rate of approximately 95%, and misoprostol alone will be closer to 90%. We will consider a greater than 5% difference to be clinically meaningful.
Detailed description
Non-surgical abortion methods have the potential to improve the quality and safety of women's reproductive health in the developing world. However, until recently, widespread availability and utilization of medical abortion with mifepristone in low resource countries has been restricted by the limited availability of mifepristone and perceived high cost of the drug, while the low and varied rates of efficacy of the misoprostol alone regimens have hindered its widespread adoption. In recent years, a handful of new mifepristone and misoprostol products have come to the market, easing the availability and reducing the cost of both drugs, and therefore making their introduction in new settings more feasible. Nonetheless, mifepristone is much more expensive than misoprostol (approximately $4 - 6 a tablet versus $0.35 a tablet) and often a large part of the cost of the medical abortion cost. In this respect, this study provides an important opportunity to better understand the real difference in efficacy of the two regimens in addition to the costs and benefits of these two non-surgical abortion regimens.
The study will contribute greatly to the literature on medical abortion. First, it will be the first randomized trial to compare two buccal regimens (and the second ever to compare mifepristone+misoprostol with misoprostol alone. Second, if proven efficacious, it promises to offer alternative regimens for use in women with gestations up to 63 days' LMP. Third, it may create evidence in support of shortening the time to abortion completion, by offering all women in the mifepristone arm the chance to complete their abortions 24 hours after mifepristone, instead of the standard 48 hours later. Lastly, it provides a unique opportunity to systematically and in a non-biased manner, compare the side effects and acceptability of these two regimens, thereby creating more information to help providers and policy makers debate the relative costs and benefits of these two medical abortion regimens.
A total of 700 women will be recruited. We assume that the efficacy of mifepristone plus buccal misoprostol is approximately 95%. The efficacy of misoprostol alone for medical abortion, via the vaginal route, is 88%. The efficacy of misoprostol alone via the buccal route is not known, nor is the efficacy via the buccal route with repeat dosing after a 24 hour interval. We expect that the efficacy with buccal misoprostol should be similar to that with vaginal misoprostol based on both pharmokinetic and clinical data.
We assume that the efficacy of mifepristone plus buccal misoprostol in our research settings will be 95%. A difference in efficacy of buccal misoprostol alone of at least 5% (90%) is clinically meaningful to providers and women.
Using alpha = 0.05 with a one-sided test and power = 0.80, the number needed to demonstrate this difference is 664 (334 in each arm). Assuming 5% will drop out or not complete the protocol, we plan to enroll a total of 700 women.
The primary endpoint is efficacy; safety, acceptability and side effects will be assessed as secondary endpoints.
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 | Experimental | Drug: mifepristone, Drug: misoprostol200 mg mifepristone+ 800 mcg buccal misoprostol |
| misoprostol | Experimental | Drug: misoprostol, Drug: placebo800 mcg buccal misoprostol+placebo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Gestational age < 63 days by LMP, 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
- Confirmed or suspected ectopic or molar pregnancy
- Contraindications to medical abortion including 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 |
|---|---|---|
| mifepristone200 mg mifepristone | Drug | mifepristone+misoprostol |
| misoprostol800 buccal misoprostol + matching placebo or 1600 buccal misoprostol | Drug | mifepristone+misoprostol, misoprostol |
| placebo800 buccal misoprostol + matching placebo or 1600 buccal misoprostol | Drug | misoprostol |
Primary outcome
Efficacy defined as complete abortion without recourse to surgical abortion.
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 13 Mar 2013.
- Derived from this study: PubMed 22682768Blum J, Raghavan S, Dabash R, Ngoc Nt, Chelli H, Hajri S, Conkling K, Winikoff B. Comparison of misoprostol-only and combined mifepristone-misoprostol regimens for home-based early medical abortion in Tunisia and Vietnam. Int J Gynaecol Obstet. 2012 Aug;118(2):166-71. doi: 10.1016/j.ijgo.2012.03.039. Epub 2012 Jun 8.
- Derived from this study: PubMed 21477682Ngoc NT, Blum J, Raghavan S, Nga NT, Dabash R, Diop A, Winikoff B. Comparing two early medical abortion regimens: mifepristone+misoprostol vs. misoprostol alone. Contraception. 2011 May;83(5):410-7. doi: 10.1016/j.contraception.2010.09.002. Epub 2010 Oct 18.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mifepristone and misoprostol in people with Pregnancy Termination, 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 13 Mar 2013. 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.
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 defined as complete abortion without recourse to surgical abortion. (time frame: 2 weeks). 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 NCT00680394, which also lists 2 linked publications.
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 13 Mar 2013.