ContraceptionPhase 3NCT03187392
Pain Relief for Birth Control Implants Insertion
A Phase 3 study testing Lidocaine Injectable Product and Lidocaine Topical Cream [LMX] in people with Contraception and Lidocaine, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during insertion of birth control implants Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Contraception, Lidocaine
- What is being tested?
- Lidocaine Injectable Product and Lidocaine Topical Cream [LMX]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jun 2017to 18 Sep 2018
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female want use subcutaneous birth control
Who cannot join
- previous scar at side of insertion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Lidocaine-prilocaine Cream Versus Lidocaine Infiltration for Pain Relief During Insertion of Subcutaneous Birth Control Implants : A Randomized Controlled Trial
The aim of our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during insertion of birth control implants
- Conditions
- Contraception, Lidocaine
- Being tested
- Lidocaine Injectable Product, Lidocaine Topical Cream [LMX]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Injectable ProductDrug
3 cm of Lidocaine- will be injected subcutaneous for 5 minutes before insertion of subcutaneous birth control implant
Lidocaine Topical Cream [LMX]Drug
3 mg of Lidocaine- will be applied to skin for 5 minutes before insertion of subcutaneous birth control implant
| Study group | Role | What they receive |
|---|---|---|
| lidocaine injection | Active comparator | Not described Receives: Drug: Lidocaine Injectable Product |
| lidocaine-prilocaine cream | Experimental | Not described Receives: Drug: Lidocaine Topical Cream [LMX] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain score during insertion of implant
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start12 Jun 2017
- Primary completion16 Sep 2018 (estimated)
- Study completion18 Sep 2018 (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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armia Michael, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187392
- Sponsor's protocol ID
- 123456
- Status last verified
- Feb 2018
- First submitted
- 13 Jun 2017
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Lidocaine-prilocaine Cream Versus Lidocaine Infiltration for Pain Relief During Insertion of Subcutaneous Birth Control Implants : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03187392
- Acronym / sponsor ID
- 123456
- Conditions
- Contraception, Lidocaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 16 Sep 2018 (estimated)
- Study completion
- 18 Sep 2018 (estimated)
- First posted
- 15 Jun 2017 (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 our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during insertion of birth control implants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine injection | Active comparator | Drug: Lidocaine Injectable Product |
| lidocaine-prilocaine cream | Experimental | Drug: Lidocaine Topical Cream [LMX] |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- female want use subcutaneous birth control
Key exclusion criteria (1 listed)
- previous scar at side of 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 |
|---|---|---|
| Lidocaine Injectable Product3 cm of Lidocaine- will be injected subcutaneous for 5 minutes before insertion of subcutaneous birth control implant | Drug | lidocaine injection |
| Lidocaine Topical Cream [LMX]3 mg of Lidocaine- will be applied to skin for 5 minutes before insertion of subcutaneous birth control implant | Drug | lidocaine-prilocaine cream |
Primary outcome
Mean pain score during insertion of implant
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Individual participant dataSharing planned: No
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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 Injectable Product and Lidocaine Topical Cream [LMX] in people with Contraception and Lidocaine, 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 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 27 Feb 2018. 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. 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?
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 insertion of implant (time frame: 10 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 27 Feb 2018.