Medical AbortionPhase 3NCT02985229
Acceptability and Feasibility of Medical Abortion in Singapore
A Phase 3 study testing Mifepristone and Misoprostol in people with Medical Abortion, run by Gynuity Health Projects at 2 sites in Singapore.
Trial summary
To test the hypothesis that a regimen of 200 mg oral mifepristone, with the option of home administration, followed by 800 μg buccal misoprostol 24 hours later for abortion through 70 days LMP will be feasible and acceptable in Singapore. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Abortion
- What is being tested?
- Mifepristone and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesSingapore
- Study dates
- Oct 2016to Jul 2017
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have an intrauterine pregnancy consistent wit gestational age ≤ 70 days
- Be 21 years of age or over
- Be willing and able to sign consent forms
- Be eligible for abortion according to current hospital guidelines
- Be able to return to the clinic and able to contact study staff or emergency medical services if needed
- Be willing to provide an address, email and/or telephone number for purposes of follow-up
- Agree to comply with the study procedures and visit schedule
Who cannot join
- confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
- chronic renal failure
- concurrent long-term corticosteroid therapy
- history of inherited porphyrias
- IUD in place (must be removed after mifepristone is administered).
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
KK Women's and Children's Hospital
Singapore
National University Hospital
Singapore
About this study
Official title: Acceptability and Feasibility of Medical Abortion in Singapore: A Study of 800 μg Buccal Misoprostol Following 200 mg Mifepristone for Abortion Through 70 Days Gestation
To test the hypothesis that a regimen of 200 mg oral mifepristone, with the option of home administration, followed by 800 μg buccal misoprostol 24 hours later for abortion through 70 days LMP will be feasible and acceptable in Singapore.
- Conditions
- Medical Abortion
- Being tested
- Mifepristone, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
The option of home or clinic administration of 200 mg oral mifepristone
MisoprostolDrug
800 μg buccal misoprostol through 70 days LMP following administration of mifepristone
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants in the study will be given the option of home administration of 200 mg oral mifepristone and 800 μg buccal misoprostol for medical abortion. Receives: Drug: Mifepristone; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful abortion
Proportion of abortions that are complete without surgical intervention
Measured: 7-10 days after mifepristone administration
Secondary outcomes (2)
Satisfaction with the medical abortion method
Proportion of women who are satisfied with the medical abortion method
Measured: 7-10 days after mifepristone administration
Preferred location of mifepristone administration
Proportion of women who select home use of mifepristone
Measured: The day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 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
- NCT02985229
- Sponsor's protocol ID
- 1028
- Status last verified
- Apr 2018
- First submitted
- 19 Oct 2016
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of Medical Abortion in Singapore: A Study of 800 μg Buccal Misoprostol Following 200 mg Mifepristone for Abortion Through 70 Days Gestation
- ClinicalTrials.gov ID
- NCT02985229
- Acronym / sponsor ID
- 1028
- Conditions
- Medical Abortion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 7 Dec 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.
To test the hypothesis that a regimen of 200 mg oral mifepristone, with the option of home administration, followed by 800 μg buccal misoprostol 24 hours later for abortion through 70 days LMP will be feasible and acceptable in Singapore.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Drug: Mifepristone, Drug: MisoprostolAll participants in the study will be given the option of home administration of 200 mg oral mifepristone and 800 μg buccal misoprostol for medical abortion. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have an intrauterine pregnancy consistent wit gestational age ≤ 70 days
- Be 21 years of age or over
- Be willing and able to sign consent forms
- Be eligible for abortion according to current hospital guidelines
- Be able to return to the clinic and able to contact study staff or emergency medical services if needed
Key exclusion criteria (5 listed)
- confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
- chronic renal failure
- concurrent long-term corticosteroid therapy
- history of inherited porphyrias
- IUD in place (must be removed after mifepristone is administered).
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 |
|---|---|---|
| MifepristoneThe option of home or clinic administration of 200 mg oral mifepristone | Drug | All participants |
| Misoprostol800 μg buccal misoprostol through 70 days LMP following administration of mifepristone | Drug | All participants |
Primary outcome
Rate of successful abortion
Time frame: 7-10 days after mifepristone administration
Proportion of abortions that are complete without surgical intervention
2 secondary outcomes
Satisfaction with the medical abortion method
Time frame: 7-10 days after mifepristone administration
Preferred location of mifepristone administration
Time frame: The day of enrollment
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 6 Apr 2018.
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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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mifepristone and Misoprostol in people with Medical Abortion, run by Gynuity Health Projects at 2 sites in Singapore.
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 7 inclusion and 5 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 6 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 2 sites in Singapore. 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 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?
Rate of successful abortion (time frame: 7-10 days 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 6 Apr 2018.