IUD Insertion PainPhase 3NCT04312048
the Effect of Isosorbide Mononitrate in Reducing Pain During Cooper Intrauterine Device Insertion
A Phase 3 study testing Isosorbide mononitrate in people with IUD Insertion Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the efficacy of isosorbide mononitrate vaginal administration in reducing pain during copper IUD insertion in nulliparous women 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?
- Isosorbide mononitrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2020to 30 Nov 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
- nulliparous women requesting copper IUD device insertion
Who cannot join
- parous women, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of Vaginal Isosorbide Mononitrate Administration in Reducing Pain During Cooper Intrauterine Device Insertion in Nulliparous Women : a Randomized Controlled Trial
The aim of the study is to evaluate the efficacy of isosorbide mononitrate vaginal administration in reducing pain during copper IUD insertion in nulliparous women
- Conditions
- IUD Insertion Pain
- Being tested
- Isosorbide mononitrate, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosorbide mononitrateDrug
one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper IUD insertion
placeboDrug
one tablet of placebo vaginally 3 hours prior to copper IUD insertion
| Study group | Role | What they receive |
|---|---|---|
| Isosorbide Mononitrate | Experimental | one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper IUD insertion Receives: Drug: Isosorbide mononitrate |
| placebo | Placebo comparator | one tablet of placebo vaginally 3 hours prior to copper IUD insertion Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain during IUD insertion
intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 100 on a 100 mm horizontal straight line, where 'zero' corresponds to no pain at all, and '100' to the worst possible pain imaginable.
Measured: 5 minutes
Secondary outcomes (1)
duration of IUD insertion
duration of IUD insertion from speculum in to speculum out
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 posted18 Mar 2020
- Study start15 Apr 2020
- Primary completion25 Oct 2020
- Study completion30 Nov 2020
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- Mahmoud alalfy, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312048
- Sponsor's protocol ID
- 00249
- Status last verified
- Jan 2021
- First submitted
- 14 Mar 2020
- Last updated
- 20 Jan 2021
- 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 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Vaginal Isosorbide Mononitrate Administration in Reducing Pain During Cooper Intrauterine Device Insertion in Nulliparous Women : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04312048
- Acronym / sponsor ID
- 00249
- Conditions
- IUD Insertion Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 25 Oct 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 18 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 the study is to evaluate the efficacy of isosorbide mononitrate vaginal administration in reducing pain during copper IUD insertion in nulliparous women
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isosorbide Mononitrate | Experimental | Drug: Isosorbide mononitrateone tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper IUD insertion |
| placebo | Placebo comparator | Drug: placeboone tablet of placebo vaginally 3 hours prior to copper IUD insertion |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- nulliparous women requesting copper IUD device insertion
Key exclusion criteria (1 listed)
- parous women, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly
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 |
|---|---|---|
| Isosorbide mononitrateone tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper IUD insertion | Drug | Isosorbide Mononitrate |
| placeboone tablet of placebo vaginally 3 hours prior to copper IUD insertion | Drug | placebo |
Primary outcome
pain during IUD insertion
Time frame: 5 minutes
intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 100 on a 100 mm horizontal straight line, where 'zero' corresponds to no pain at all, and '100' to the worst possible pain imaginable.
1 secondary outcome
duration of IUD insertion
Time frame: 5 minutes
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 20 Jan 2021.
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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.
Mahmoud alalfy, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isosorbide mononitrate in people with IUD Insertion Pain, run by Cairo 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 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: finished, as of the sponsor's last update on 20 Jan 2021. 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 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?
pain during IUD insertion (time frame: 5 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 20 Jan 2021.