Menstrual RegulationPhase 4NCT01798017
Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh
A Phase 4 study testing Mifepristone and misoprostol in people with Menstrual Regulation, run by Gynuity Health Projects at 8 sites in Bangladesh.
Trial summary
This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Regulation
- 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
- 1,738 participants
- Where
- 8 sitesBangladesh
- Study dates
- Nov 2012to Aug 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be willing and able to sign consent forms;
- Be eligible for menstrual regulation (MR) services according to clinician's assessment;
- Be willing to undergo a surgical evacuation if necessary;
- Be willing to provide a urine sample prior to administration of the mifepristone
- Have ready and easy access to a telephone and
- 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 allergy to mifepristone, misoprostol or other prostaglandin;
- Hemorrhagic disorders or concurrent anticoagulant therapy;
- Inherited porphyrias; or
- Other serious physical or mental health conditions.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Bangladesh8 sites
Aminbazar Rural Dispensary
Aminbazar, Dhaka Division
Chartarapur UH & FWC
Chandrapur, Rajshahi Division
Mohammadpur Fertility Services and Training Center
Dhaka
Goyeshpur UH &FWC
Goyespur, Rajshahi Division
MCH Unit, Sadar Upazilla
Pābna, Rajshahi Division
Pabna MCWC
Pābna, Rajshahi Division
MCH-Unit, Upazilla Health Center
Savar Upazila, Dhaka Division
Tetulzhora UH&FWC
Tetuljhora, Dhaka Division
About this study
This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.
Read the detailed description
This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.
The specific aims of this project are as follows:
- Assess whether a uterine evacuation regimen that allows women the option of taking their misoprostol outside the facility and which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is feasible for introduction in a range of clinical settings in government facilities in Bangladesh;
- Determine whether a mifepristone-misoprostol regimen for uterine evacuation is acceptable to women and providers; and
- Determine what proportion of women, if offered the choice, would prefer to take misoprostol in the facility and what proportion would prefer to take it outside the facility.
- Conditions
- Menstrual Regulation
- Being tested
- Mifepristone and misoprostol
- Keywords
- menstrual regulation, mifepristone, misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone and misoprostolDrug
Women will receive 200mg mifepristone followed in 24-48h by 800mcg bucccal misoprsotol
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone-misoprostol | Experimental | Women will receive 200mg oral mifepristone followed in 24-48h by 800mcg buccal misoprostol Receives: Drug: Mifepristone and misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful menstrual regulation without the need for a surgical evacuation
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menstrual RegulationStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,738 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hillary J Bracken, PhD, Principal investigator, Gynuity Health ProjectsLaura Reichenbach, PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798017
- Sponsor's protocol ID
- 1004
- Status last verified
- Mar 2013
- First submitted
- 21 Feb 2013
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alam A, Lotarevich T, Das TR, Reichenbach L, Bracken H. Mifepristone-misoprostol for menstrual regulation in public sector facilities in Bangladesh. Int J Gynaecol Obstet. 2018 Feb;140(2):205-210. doi: 10.1002/ijgo.12356. Epub 2017 Nov 9.
PubMed 29049861
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh
- ClinicalTrials.gov ID
- NCT01798017
- Acronym / sponsor ID
- 1004
- Conditions
- Menstrual Regulation
- Keywords
- menstrual regulation, mifepristone, misoprostol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,738 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Feb 2013 (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 open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.
Detailed description
This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.
The specific aims of this project are as follows:
- Assess whether a uterine evacuation regimen that allows women the option of taking their misoprostol outside the facility and which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is feasible for introduction in a range of clinical settings in government facilities in Bangladesh;
- Determine whether a mifepristone-misoprostol regimen for uterine evacuation is acceptable to women and providers; and
- Determine what proportion of women, if offered the choice, would prefer to take misoprostol in the facility and what proportion would prefer to take it outside the facility.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mifepristone-misoprostol | Experimental | Drug: Mifepristone and misoprostolWomen will receive 200mg oral mifepristone followed in 24-48h by 800mcg buccal misoprostol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be willing and able to sign consent forms;
- Be eligible for menstrual regulation (MR) services according to clinician's assessment;
- Be willing to undergo a surgical evacuation if necessary;
- Be willing to provide a urine sample prior to administration of the mifepristone
- Have ready and easy access to a telephone and
Key exclusion criteria (7 listed)
- • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
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 |
|---|---|---|
| Mifepristone and misoprostolWomen will receive 200mg mifepristone followed in 24-48h by 800mcg bucccal misoprsotol | Drug | Mifepristone-misoprostol |
Primary outcome
successful menstrual regulation without the need for a surgical evacuation
Time frame: 14 days
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 10 Dec 2015.
- Derived from this study: PubMed 29049861Alam A, Lotarevich T, Das TR, Reichenbach L, Bracken H. Mifepristone-misoprostol for menstrual regulation in public sector facilities in Bangladesh. Int J Gynaecol Obstet. 2018 Feb;140(2):205-210. doi: 10.1002/ijgo.12356. Epub 2017 Nov 9.
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Intervention in Executive Functions and Emotional Self-Regulation in Adolescents With Primary Dysmenorrhea
Menstrual Cramps
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.
Hillary J Bracken, PhD principal investigator
Gynuity Health Projects
Laura Reichenbach, PhD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mifepristone and misoprostol in people with Menstrual Regulation, run by Gynuity Health Projects at 8 sites in Bangladesh.
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 6 inclusion and 7 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 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Bangladesh. 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?
successful menstrual regulation without the need for a surgical evacuation (time frame: 14 days). 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 NCT01798017, which also lists 1 linked publication.
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 10 Dec 2015; AzTrials last refreshed its copy on 7 Nov 2026.