IUD Insertion PainPhase 3NCT04301349
Dinoprostone vs Misoprostol Before LNG-IUD Insertion
A Phase 3 study testing vaginal dinoprostone and vaginal misoprostol in people with IUD Insertion Pain, run by Cairo University.
Trial summary
the aim of this study is to compare the safety and efficacy of vaginal dinoprostone vs vaginal misoprostol administration prior to IUD insertion in multiparous women regarding reduction in iud insertion pain Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- IUD Insertion Pain
- What is being tested?
- vaginal dinoprostone and vaginal misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2020to 30 Jun 2020
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- multiparous women requesting IUD insetion
Who cannot join
- active genital infection,uterine anomalies, and contraindication or allergy to dinoprostone or misoprostol
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Vaginal Dinoprostone and Vaginal Misoprostol Prior to IUD Insertion in Multiparous Women
the aim of this study is to compare the safety and efficacy of vaginal dinoprostone vs vaginal misoprostol administration prior to IUD insertion in multiparous women regarding reduction in iud insertion pain
- Conditions
- IUD Insertion Pain
- Being tested
- vaginal dinoprostone, vaginal misoprostol, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal dinoprostoneDrug
two tablets of vaginal dinoprostone (6 mg) 3 hours prior to IUD insertion
vaginal misoprostolDrug
two tablets of vaginal misoprostol (400 mcg) 3 hours prior to IUD insertion
placeboDrug
two tablets of placebo given 3 hours prior to IUD insertion
| Study group | Role | What they receive |
|---|---|---|
| vaginal dinoprostone | Experimental | vaginal dinoprostone 6 mg (two tablets) 3 hours prior to IUD insertion Receives: Drug: vaginal dinoprostone |
| vaginal misoprostol | Active comparator | vaginal misoprostol 400 mcg (two tablets) 3 hours prior to IUD insertion Receives: Drug: vaginal misoprostol |
| placebo | Placebo comparator | two tablets of placebo similar in shape ,color, odor to the study drugs Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain during IUD insertion: visual analog scale
pain during IUD insertion assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable
Measured: 2 minutes
Secondary outcomes (1)
duration of IUD insertion
duration of IUD insertion measured in minutes
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start15 Mar 2020 (estimated)
- Primary completion15 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUD Insertion PainStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- AHMED SAMY, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301349
- Sponsor's protocol ID
- dinoprostone IUDs
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 10 Mar 2020
- 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 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Vaginal Dinoprostone and Vaginal Misoprostol Prior to IUD Insertion in Multiparous Women
- ClinicalTrials.gov ID
- NCT04301349
- Acronym / sponsor ID
- dinoprostone IUDs
- Conditions
- IUD Insertion Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (estimated)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 10 Mar 2020 (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.
the aim of this study is to compare the safety and efficacy of vaginal dinoprostone vs vaginal misoprostol administration prior to IUD insertion in multiparous women regarding reduction in iud insertion pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vaginal dinoprostone | Experimental | Drug: vaginal dinoprostonevaginal dinoprostone 6 mg (two tablets) 3 hours prior to IUD insertion |
| vaginal misoprostol | Active comparator | Drug: vaginal misoprostolvaginal misoprostol 400 mcg (two tablets) 3 hours prior to IUD insertion |
| placebo | Placebo comparator | Drug: placebotwo tablets of placebo similar in shape ,color, odor to the study drugs |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- multiparous women requesting IUD insetion
Key exclusion criteria (1 listed)
- active genital infection,uterine anomalies, and contraindication or allergy to dinoprostone or 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 |
|---|---|---|
| vaginal dinoprostonetwo tablets of vaginal dinoprostone (6 mg) 3 hours prior to IUD insertion | Drug | vaginal dinoprostone |
| vaginal misoprostoltwo tablets of vaginal misoprostol (400 mcg) 3 hours prior to IUD insertion | Drug | vaginal misoprostol |
| placebotwo tablets of placebo given 3 hours prior to IUD insertion | Drug | placebo |
Primary outcome
pain during IUD insertion: visual analog scale
Time frame: 2 minutes
pain during IUD insertion assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable
1 secondary outcome
duration of IUD insertion
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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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.
AHMED SAMY principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vaginal dinoprostone and vaginal misoprostol in people with IUD Insertion Pain, run by Cairo University.
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 1 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: status not confirmed, as of the sponsor's last update on 10 Mar 2020. 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. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AHMED SAMY, MD (+201100681167, ahmedsamy8233@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain during IUD insertion: visual analog scale (time frame: 2 minutes). 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 10 Mar 2020.