ContraceptionPhase 3NCT04339049
Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in IUD Insertion
A Phase 3 study testing lidocaine spray and vaginal misoprostol in people with Contraception, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of the present study is to compare the safety and efficacy of lidocaine spray versus misoprostol in reducing pain during IUD insertion in adolescents and nulliparous women Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- lidocaine spray and vaginal misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 30 Jul 2021
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- adolescent and young nulliparous women requesting IUD insertion
Who cannot join
- multiparous women, contraindications to IUD insertion or to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in Reducing Pain During IUD Insertion in Adolescents and Nulliparous Women: a Randomized Controlled Trial
the aim of the present study is to compare the safety and efficacy of lidocaine spray versus misoprostol in reducing pain during IUD insertion in adolescents and nulliparous women
- Conditions
- Contraception
- Being tested
- lidocaine spray, vaginal misoprostol, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine sprayDrug
four puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion
vaginal misoprostolDrug
vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
placeboDrug
vaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
| Study group | Role | What they receive |
|---|---|---|
| lidocaine spray | Experimental | four puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion Receives: Drug: lidocaine spray |
| vaginal misoprostol | Active comparator | vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement Receives: Drug: vaginal misoprostol |
| placebo | Placebo comparator | vaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain during IUD insertion
pain during IUD insertion evaluated by visual analog scale where 0 denotes no pain and 10 cm denotes the worst 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 posted8 Apr 2020
- Study start1 May 2020
- Primary completion17 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Algazeerah hospital
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339049
- Sponsor's protocol ID
- lidocaine IUD
- Status last verified
- Nov 2021
- First submitted
- 7 Apr 2020
- Last updated
- 10 Dec 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 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in Reducing Pain During IUD Insertion in Adolescents and Nulliparous Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04339049
- Acronym / sponsor ID
- lidocaine IUD
- Conditions
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Algazeerah hospital
- Study start
- 1 May 2020 (actual)
- Primary completion
- 17 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 8 Apr 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 present study is to compare the safety and efficacy of lidocaine spray versus misoprostol in reducing pain during IUD insertion in adolescents and nulliparous women
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 |
|---|---|---|
| lidocaine spray | Experimental | Drug: lidocaine sprayfour puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion |
| vaginal misoprostol | Active comparator | Drug: vaginal misoprostolvaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement |
| placebo | Placebo comparator | Drug: placebovaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- adolescent and young nulliparous women requesting IUD insertion
Key exclusion criteria (1 listed)
- multiparous women, contraindications to IUD insertion or to study drugs
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 |
|---|---|---|
| lidocaine sprayfour puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion | Drug | lidocaine spray |
| vaginal misoprostolvaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement | Drug | vaginal misoprostol |
| placebovaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement | Drug | placebo |
Primary outcome
pain during IUD insertion
Time frame: 5 minutes
pain during IUD insertion evaluated by visual analog scale where 0 denotes no pain and 10 cm denotes the worst 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 10 Dec 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.
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 3 study testing lidocaine spray and vaginal misoprostol in people with Contraception, 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 10 Dec 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 10 Dec 2021.