MisoprostolPhase 3MisoprostolNCT03140384
Compare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA)
A Phase 3 study testing Assess the efficacy and side effects of Misoprostol according to the route of administration in people with Misoprostol and Drug-induced Abortion, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
In France, drug-induced abortion is allowed up to 9SA, after which the surgical route is preferred. Mifepristone 600mg is used 36-48 hours before the introduction of Misoprostol. This is recommended orally at a dose of 400 μg. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Misoprostol, Drug-induced Abortion
- What is being tested?
- Assess the efficacy and side effects of Misoprostol according to the route of administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 20 Aug 2017to 20 Jul 2019
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women > 18 years hospitalized using abortions between 7 and 9 SA and after informed consent,
- Affiliation to a social security scheme.
Who cannot join
- Minor or major women under guardianship or curatorship
- BMI <18.5 (thinness)
- Ambulatory
- Several abortions on the duration of the study
- Take Mifepristone> 48 hours before taking Misoprostol
- Contraindications to Misoprostol: Prostaglandin Allergy
Trial locations and contacts
1 site in 1 country.
About this study
In France, drug-induced abortion is allowed up to 9SA, after which the surgical route is preferred. Mifepristone 600mg is used 36-48 hours before the introduction of Misoprostol. This is recommended orally at a dose of 400 μg. There are currently several studies on the subject, including a meta-analysis of the 2011 Cochrane Database, but doses, routes of administration and gestational age differ in all studies. Currently, HAS recommends the vaginal route at the dose of 800μg for stopped pregnancies. It is therefore necessary to compare the different routes of administration of Misoprostol at the same dose to allow to change our French recommendations on the medicinal abortion and perhaps also to recommend the vaginal route in this indication.
- Conditions
- Misoprostol, Drug-induced Abortion
- Being tested
- Assess the efficacy and side effects of Misoprostol according to the route of administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assess the efficacy and side effects of Misoprostol according to the route of administrationBiological
Assess the efficacy and side effects of Misoprostol according to the route of administration
| Study group | Role | What they receive |
|---|---|---|
| Administration of oral Misoprostol | Active comparator | Not described Receives: Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration |
| Administration of Misoprostol vaginally | Active comparator | Not described Receives: Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration |
| Administration of buccal Misoprostol | Active comparator | Not described Receives: Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete pregnancy evacuation on ultrasound at 3 weeks
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start20 Aug 2017 (estimated)
- Primary completion20 Jul 2019 (estimated)
- Study completion20 Jul 2019 (estimated)
Why it stopped: no regulatory approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MisoprostolStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140384
- Sponsor's protocol ID
- PI2016_843_0033
- Acronym
- Misoprostol
- Status last verified
- Apr 2018
- First submitted
- 27 Apr 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA)
- ClinicalTrials.gov ID
- NCT03140384
- Acronym / sponsor ID
- Misoprostol / PI2016_843_0033
- Conditions
- Misoprostol, Drug-induced Abortion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no regulatory approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 20 Aug 2017 (estimated)
- Primary completion
- 20 Jul 2019 (estimated)
- Study completion
- 20 Jul 2019 (estimated)
- First posted
- 4 May 2017 (actual)
- 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.
In France, drug-induced abortion is allowed up to 9SA, after which the surgical route is preferred. Mifepristone 600mg is used 36-48 hours before the introduction of Misoprostol. This is recommended orally at a dose of 400 μg. There are currently several studies on the subject, including a meta-analysis of the 2011 Cochrane Database, but doses, routes of administration and gestational age differ in all studies. Currently, HAS recommends the vaginal route at the dose of 800μg for stopped pregnancies. It is therefore necessary to compare the different routes of administration of Misoprostol at the same dose to allow to change our French recommendations on the medicinal abortion and perhaps also to recommend the vaginal route in this indication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Administration of oral Misoprostol | Active comparator | Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration |
| Administration of Misoprostol vaginally | Active comparator | Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration |
| Administration of buccal Misoprostol | Active comparator | Biological: Assess the efficacy and side effects of Misoprostol according to the route of administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women > 18 years hospitalized using abortions between 7 and 9 SA and after informed consent,
- Affiliation to a social security scheme.
Key exclusion criteria (6 listed)
- Minor or major women under guardianship or curatorship
- BMI <18.5 (thinness)
- Ambulatory
- Several abortions on the duration of the study
- Take Mifepristone> 48 hours before taking Misoprostol
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 |
|---|---|---|
| Assess the efficacy and side effects of Misoprostol according to the route of administrationAssess the efficacy and side effects of Misoprostol according to the route of administration | Biological | Administration of Misoprostol vaginally, Administration of buccal Misoprostol, Administration of oral Misoprostol |
Primary outcome
Complete pregnancy evacuation on ultrasound at 3 weeks
Time frame: 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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Not yet recruitingPhase 3
Optimal Time Interval Between Mifepristone and Misoprostol Administration for Early Pregnancy Loss
Early Pregnancy Loss
Recruiting
Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)
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Not yet recruitingPhase 1/2
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Assess the efficacy and side effects of Misoprostol according to the route of administration in people with Misoprostol and Drug-induced Abortion, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 2 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: withdrawn, as of the sponsor's last update on 17 Apr 2018. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Complete pregnancy evacuation on ultrasound at 3 weeks (time frame: 3 weeks). 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 17 Apr 2018.