Abortion, 3 MonthsPhase 4NCT02720991
A Pilot of an Outpatient Regimen of Medical Abortion With Mifepristone and Sublingual Misoprostol in the 11 and 12 Weeks
A Phase 4 study testing Mifepristone and Sublingual misoprostol in people with Abortion, 3 Months, run by Gynuity Health Projects.
Trial summary
A pilot study on the acceptability and feasibility with Mifepristone and 400 mg of sub-lingual Misoprostol between 71-77 and 78-84 days of gestation for 50 cases. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, 3 Months
- What is being tested?
- Mifepristone and Sublingual misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Apr 2015
- 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 of 71-84 days of amenorrhea
- Seeking abortion services
- Prepared and able to sign the consent forms
- Accept to conform to study procedures and scheduled visits
Who cannot join
- Does not meet study criteria
About this study
Official title: A Pilot Study of the Acceptability and Feasibility of an Out-patient Regimen of Medical Abortion With Mifepristone and 400 mcg Sublingual Misoprostol at 71-77 and 78-84 Days Gestation
A pilot study on the acceptability and feasibility with Mifepristone and 400 mg of sub-lingual Misoprostol between 71-77 and 78-84 days of gestation for 50 cases.
Read the detailed description
The study will enroll 25 women in each gestational age group. All participants will be submitted to routine screening as per current practice at La Rabta Hospital. The eligible women will receive a dose of 200 mg of mifepristone and 400 ug of misoprostol to take at home sublingually .
The first 5 women enrolled in each gestational age group will be asked to return to the clinic 24-48 hours after the initial visit to take misoprostol at the clinic and wait during a 3 hour observational period before returning to their homes. After this initial phase, the women will be asked to self-administer the misoprostol at home 24-48 hours after the administration of mifepristone and to return to the clinic 7-10 days later. At follow-up, a healthcare provider will assure her that her medical abortion is complete and after will ask women to respond to a series of questions in an exit interview.
- Conditions
- Abortion, 3 Months
- Being tested
- Mifepristone, Sublingual misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called miropristone, Mifeprex, Mifegyn
200 mg of oral mifepristone
Sublingual misoprostolDrug
Also called cytotec
400 ug of misoprostol sublingually following mifepristone
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone and sublingual misoprostol | Experimental | 200 mg mifepristone and 400 ug sublingual misoprostol Receives: Drug: Mifepristone; Drug: Sublingual misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of an ambulatory medical abortion treatment of 200 mg of mifepristone orally followed b 400 mcg of sublingual misoprostol at home, based on responses to questionnaire
Measured: 1 week
Secondary outcomes (1)
Level of tolerance of side effects, based on responses to questionnaire
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startJul 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, 3 MonthsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital La Rabta
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720991
- Sponsor's protocol ID
- 1014
- Status last verified
- Mar 2016
- First submitted
- 10 Mar 2016
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Acceptability and Feasibility of an Out-patient Regimen of Medical Abortion With Mifepristone and 400 mcg Sublingual Misoprostol at 71-77 and 78-84 Days Gestation
- ClinicalTrials.gov ID
- NCT02720991
- Acronym / sponsor ID
- 1014
- Conditions
- Abortion, 3 Months
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Hopital La Rabta
- Study start
- Jul 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Mar 2016 (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 pilot study on the acceptability and feasibility with Mifepristone and 400 mg of sub-lingual Misoprostol between 71-77 and 78-84 days of gestation for 50 cases.
Detailed description
The study will enroll 25 women in each gestational age group. All participants will be submitted to routine screening as per current practice at La Rabta Hospital. The eligible women will receive a dose of 200 mg of mifepristone and 400 ug of misoprostol to take at home sublingually .
The first 5 women enrolled in each gestational age group will be asked to return to the clinic 24-48 hours after the initial visit to take misoprostol at the clinic and wait during a 3 hour observational period before returning to their homes. After this initial phase, the women will be asked to self-administer the misoprostol at home 24-48 hours after the administration of mifepristone and to return to the clinic 7-10 days later. At follow-up, a healthcare provider will assure her that her medical abortion is complete and after will ask women to respond to a series of questions in an exit interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mifepristone and sublingual misoprostol | Experimental | Drug: Mifepristone, Drug: Sublingual misoprostol200 mg mifepristone and 400 ug sublingual misoprostol |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Gestational age of 71-84 days of amenorrhea
- Seeking abortion services
- Prepared and able to sign the consent forms
- Accept to conform to study procedures and scheduled visits
Key exclusion criteria (1 listed)
- Does not meet study criteria
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 |
|---|---|---|
| MifepristoneAlso: miropristone, Mifeprex, Mifegyn200 mg of oral mifepristone | Drug | Mifepristone and sublingual misoprostol |
| Sublingual misoprostolAlso: cytotec400 ug of misoprostol sublingually following mifepristone | Drug | Mifepristone and sublingual misoprostol |
Primary outcome
Acceptability of an ambulatory medical abortion treatment of 200 mg of mifepristone orally followed b 400 mcg of sublingual misoprostol at home, based on responses to questionnaire
Time frame: 1 week
1 secondary outcome
Level of tolerance of side effects, based on responses to questionnaire
Time frame: 1 week
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 28 Mar 2016.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mifepristone and Sublingual misoprostol in people with Abortion, 3 Months, run by Gynuity Health Projects.
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 1 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 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Acceptability of an ambulatory medical abortion treatment of 200 mg of mifepristone orally followed b 400 mcg of sublingual misoprostol at home, based on responses to questionnaire (time frame: 1 week). 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 28 Mar 2016.