ContraceptionPhase 3NCT04340778
Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion
A Phase 3 study testing vaginal dinoprostone and Lidocaine-prilocaine Cream in people with Contraception, run by Cairo University.
Trial summary
the aim of the present study is to Compare Safety and Efficacy of Vaginal dinoprostone Versus Lidocaine-prilocaine Cream in copper IUD Insertion in nulliparous women: a randomized controlled trial 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?
- vaginal dinoprostone and Lidocaine-prilocaine Cream
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2020to 5 Sep 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- nulliparous women requesting copper IUD insertion
Who cannot join
- multiparous women, active vaginal or cervical infections and contraindications to IUD Insertion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion in Nulliparous Women: a Randomized Controlled Trial
the aim of the present study is to Compare Safety and Efficacy of Vaginal dinoprostone Versus Lidocaine-prilocaine Cream in copper IUD Insertion in nulliparous women: a randomized controlled trial
- Conditions
- Contraception
- Being tested
- vaginal dinoprostone, Lidocaine-prilocaine Cream, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal dinoprostoneDrug
vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion
Lidocaine-prilocaine CreamDrug
Lidocaine-prilocaine Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion
placeboDrug
inert placebo Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion
| Study group | Role | What they receive |
|---|---|---|
| vaginal dinoprostone | Experimental | vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion. Receives: Drug: vaginal dinoprostone |
| lidocaine prilocaine cream | Active comparator | Lidocaine-prilocaine Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion Receives: Drug: Lidocaine-prilocaine Cream |
| placebo | Placebo comparator | inert placebo Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before 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: visual analog scale
pain during copper IUD insertion evaluated by 10 cm visual analog scale where 0 denotes no pain and 10 cm denotes the worst pain imaginable
Measured: 5 minutes
Secondary outcomes (1)
duration of insertion
duration of 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 posted10 Apr 2020
- Study start30 Apr 2020 (estimated)
- Primary completion30 Aug 2020 (estimated)
- Study completion5 Sep 2020 (estimated)
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
- 210 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340778
- Sponsor's protocol ID
- dinoprostone vs LP cream
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 10 Apr 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 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion in Nulliparous Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04340778
- Acronym / sponsor ID
- dinoprostone vs LP cream
- Conditions
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2020 (estimated)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 5 Sep 2020 (estimated)
- First posted
- 10 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 Safety and Efficacy of Vaginal dinoprostone Versus Lidocaine-prilocaine Cream in copper IUD Insertion in nulliparous women: a randomized controlled trial
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 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion. |
| lidocaine prilocaine cream | Active comparator | Drug: Lidocaine-prilocaine CreamLidocaine-prilocaine Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion |
| placebo | Placebo comparator | Drug: placeboinert placebo Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- nulliparous women requesting copper IUD insertion
Key exclusion criteria (1 listed)
- multiparous women, active vaginal or cervical infections and contraindications to IUD Insertion.
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 dinoprostonevaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion | Drug | vaginal dinoprostone |
| Lidocaine-prilocaine CreamLidocaine-prilocaine Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion | Drug | lidocaine prilocaine cream |
| placeboinert placebo Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion | Drug | placebo |
Primary outcome
pain during IUD insertion: visual analog scale
Time frame: 5 minutes
pain during copper IUD insertion evaluated by 10 cm visual analog scale where 0 denotes no pain and 10 cm denotes the worst pain imaginable
1 secondary outcome
duration of 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 Apr 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vaginal dinoprostone and Lidocaine-prilocaine Cream in people with Contraception, 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 Apr 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 (+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: 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 Apr 2020.