Family PlanningPhase 4INDO-IUDNCT02711358
Indomethacin Use in Pain Relief During Intrauterine Device Insertion
A Phase 4 study testing indomethacin suppositories in people with Family Planning, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of the investigators study is to test the analgesic effect of rectal indomethacin during Intrauterine device insertion. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women only
- Conditions the study is for
- Family Planning
- What is being tested?
- indomethacin suppositories
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Oct 2016
- 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 20 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women not taken analgesics or anxiolytics in the 24 hours prior insertion
- Women not taken misoprostol prior to intrauterine device insertion
- Women who will accept to participate in the study
Who cannot join
- Any contraindication to intrauterine device placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rectal Indomethacin Use in Pain Relief During Intrauterine Device Insertion: A Randomized Controlled Trial
The aim of the investigators study is to test the analgesic effect of rectal indomethacin during Intrauterine device insertion.
- Conditions
- Family Planning
- Being tested
- indomethacin suppositories, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indomethacin suppositoriesDrug
The patients will be instructed to self-administer a single rectal dose of 50 mg indomethacin 30 min before the scheduled time of the procedure
placeboDrug
The patient swill be instructed to self-administer a single rectal dose of placebo 30 min before the scheduled time of the procedure
| Study group | Role | What they receive |
|---|---|---|
| indomethacin | Experimental | indomethacin suppositories Receives: Drug: indomethacin suppositories |
| placebo | Placebo comparator | placebo suppositories Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain score during IUD insertion
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family PlanningStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711358
- Sponsor's protocol ID
- INDO
- Acronym
- INDO-IUD
- Status last verified
- Nov 2016
- First submitted
- 14 Mar 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Indomethacin Use in Pain Relief During Intrauterine Device Insertion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02711358
- Acronym / sponsor ID
- INDO-IUD / INDO
- Conditions
- Family Planning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 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.
The aim of the investigators study is to test the analgesic effect of rectal indomethacin during Intrauterine device insertion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| indomethacin | Experimental | Drug: indomethacin suppositoriesindomethacin suppositories |
| placebo | Placebo comparator | Drug: placeboplacebo suppositories |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women not taken analgesics or anxiolytics in the 24 hours prior insertion
- Women not taken misoprostol prior to intrauterine device insertion
- Women who will accept to participate in the study
Key exclusion criteria (1 listed)
- Any contraindication to intrauterine device placement
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 |
|---|---|---|
| indomethacin suppositoriesThe patients will be instructed to self-administer a single rectal dose of 50 mg indomethacin 30 min before the scheduled time of the procedure | Drug | indomethacin |
| placeboThe patient swill be instructed to self-administer a single rectal dose of placebo 30 min before the scheduled time of the procedure | Drug | placebo |
Primary outcome
Mean pain score during IUD insertion
Time frame: intraoperative
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 29 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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 4 study testing indomethacin suppositories in people with Family Planning, run by Assiut University at 1 site in Egypt.
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 3 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 29 Nov 2016. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Mean pain score during IUD insertion (time frame: intraoperative). 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 29 Nov 2016.