IUD Insertion ComplicationPhase 4JaydessNCT02706509
Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women
A Phase 4 study testing Tramadol, Verbal anesthesia and Jaydess in people with IUD Insertion Complication, run by Meir Medical Center.
Trial summary
A multicenter prospective interventional comparative study that investigate pain management during Jaydess insertion in nulliparous women that will be tested by the analgesic affects of oral tramadol or 'verbal anesthesia' on the patients. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUD Insertion Complication
- What is being tested?
- Tramadol, Verbal anesthesia and Jaydess
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2018
- Phase
- Phase 4
- 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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous women aged 18-48 years, interested in a long acting, reversible contraception method. Each read and signed the informed consent.
Who cannot join
- Women suffering from:
- Acute or recurrent pelvic inflammatory disease.
- Acute cervicitis or acute Vaginitis.
- Current cervical intraepithelial lesion.
- Current any genital malignancy.
- Progesterone hypersensitivity.
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- progesterone-sensitive tumours (e.g. breast tumours).
- Abnormal vaginal bleeding.
- Congenital or acquired uterine anomaly.
- Distorted uterine cavity e.g. fibroid or polyp.
- Impaired liver functions, or liver tumour.
- Known hypersensitivity to the active substance or to any of the excipients of Jaydess.
- Contraindications to Tramadol according to approved product information:
- In hypersensitivity to tramadol or any of the excipients.
- In patients who are receiving monoamine oxidase inhibitors or within 2 weeks (14 days) of their withdrawal.
- In patients with epilepsy not adequately controlled by treatment.
- Vaginismus.
About this study
Official title: Comparison Between the Analgesic Affects of Tramadol® and "Verbal Anesthesia" on Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women
A multicenter prospective interventional comparative study that investigate pain management during Jaydess insertion in nulliparous women that will be tested by the analgesic affects of oral tramadol or 'verbal anesthesia' on the patients.
Read the detailed description
Most intrauterine contraception (IUC) insertions do not require pain management. However, small proportions of nulliparous women experience substantial pain that needs to be proactively managed No prophylactic pharmacological intervention has been adequately evaluated to support routine use for pain reduction during or after IUC insertion. Women's anxiety about the procedure may contribute to higher levels of perceived pain, which highlights the importance of counselling, and creating a trustworthy, unhurried and professional atmosphere in which the experience of the provider also has a major role; a situation frequently referred to as 'verbal anaesthesia'.
It has been proven in the past that the use of oral Tramadol can reduce the pain in the insertion.
In the study investigators will compare the analgesic affects of oral Tramadol and verbal anesthesia on pain relief during Jaydess insertion in nulliparous women.
- Conditions
- IUD Insertion Complication
- Being tested
- Tramadol, Verbal anesthesia, Jaydess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Also called ultram
patient will receive oral Tramadol 50 mg an hour before IUD insertion
Verbal anesthesiaBehavioural
patient will receive full explanation about the procedure for five minutes before IUD insertion
JaydessDevice
Patient will go through an insertion of Jaydess intrauterine device.
| Study group | Role | What they receive |
|---|---|---|
| oral tramadol | Active comparator | Patients will receive oral Tramadol 50 mg capsules (n=50)' . After an hour, Jaydess intrauterine device will be inserted. Receives: Drug: Tramadol; Device: Jaydess |
| verbal anesthesia | Sham comparator | 'verbal anesthesia' (n=50) After an hour, Jaydess intrauterine device will be inserted Receives: Behavioral: Verbal anesthesia; Device: Jaydess |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pre-insertion therapy (oral analgesia and oral Tramadol) as pain management during insertion of Jaydess measured on a VAS (0-100 mm).
The primary outcome will be the patient evaluation of pain during the procedure. The patient will be asked to assess the pain according to VAS scale (10-100 mm) 10 minutes after the insertion of Jaydess intrauterine device.
Measured: Day of insertion
Secondary outcomes (4)
Evaluation of pain during menstruation one month after the insertion of Jaydess intrauterine device
The patient will be asked to asses the severity of pain during menstruation one month after the insertion of Jaydess intrauterine device according to VAS scale (1-100 mm)
Measured: one month after insertion
Evaluation of pain during menstruation six month after the insertion of Jaydess
The patient will be asked to asses the severity of pain during menstruation six month after the insertion of Jaydess intrauterine device according to VAS scale (1-100 mm)
Measured: six month after insertion
Evaluation of the amount of bleeding during menstruation one month after the insertion of Jaydess intrauterine device
The patient will be asked to asses the amount of bleeding during menstruation one month after the insertion of Jaydess intrauterine device according to a verbal scale (non, minor, medium, sever, very sever)
Measured: one month after insertion
Evaluation of the amount of bleeding during menstruation six month after the insertion of Jaydess intrauterine device
The patient will be asked to asses the amount of bleeding during menstruation six month after the insertion of Jaydess intrauterine device according to a verbal scale (non, minor, medium, sever, very sever)
Measured: six month after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUD Insertion ComplicationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706509
- Sponsor's protocol ID
- 0063-15-MMC
- Acronym
- Jaydess
- Status last verified
- Feb 2016
- First submitted
- 17 Feb 2016
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Analgesic Affects of Tramadol® and "Verbal Anesthesia" on Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women
- ClinicalTrials.gov ID
- NCT02706509
- Acronym / sponsor ID
- Jaydess / 0063-15-MMC
- Conditions
- IUD Insertion Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 Mar 2016 (estimated)
- 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.
A multicenter prospective interventional comparative study that investigate pain management during Jaydess insertion in nulliparous women that will be tested by the analgesic affects of oral tramadol or 'verbal anesthesia' on the patients.
Detailed description
Most intrauterine contraception (IUC) insertions do not require pain management. However, small proportions of nulliparous women experience substantial pain that needs to be proactively managed No prophylactic pharmacological intervention has been adequately evaluated to support routine use for pain reduction during or after IUC insertion. Women's anxiety about the procedure may contribute to higher levels of perceived pain, which highlights the importance of counselling, and creating a trustworthy, unhurried and professional atmosphere in which the experience of the provider also has a major role; a situation frequently referred to as 'verbal anaesthesia'.
It has been proven in the past that the use of oral Tramadol can reduce the pain in the insertion.
In the study investigators will compare the analgesic affects of oral Tramadol and verbal anesthesia on pain relief during Jaydess insertion in nulliparous women.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral tramadol | Active comparator | Drug: Tramadol, Device: JaydessPatients will receive oral Tramadol 50 mg capsules (n=50)' . After an hour, Jaydess intrauterine device will be inserted. |
| verbal anesthesia | Sham comparator | Behavioral: Verbal anesthesia, Device: Jaydess'verbal anesthesia' (n=50) After an hour, Jaydess intrauterine device will be inserted |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Nulliparous women aged 18-48 years, interested in a long acting, reversible contraception method. Each read and signed the informed consent.
Key exclusion criteria (17 listed)
- Acute or recurrent pelvic inflammatory disease.
- Acute cervicitis or acute Vaginitis.
- Current cervical intraepithelial lesion.
- Current any genital malignancy.
- Progesterone hypersensitivity.
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 |
|---|---|---|
| TramadolAlso: ultrampatient will receive oral Tramadol 50 mg an hour before IUD insertion | Drug | oral tramadol |
| Verbal anesthesiapatient will receive full explanation about the procedure for five minutes before IUD insertion | Behavioural | verbal anesthesia |
| JaydessPatient will go through an insertion of Jaydess intrauterine device. | Device | oral tramadol, verbal anesthesia |
Primary outcome
Evaluation of pre-insertion therapy (oral analgesia and oral Tramadol) as pain management during insertion of Jaydess measured on a VAS (0-100 mm).
Time frame: Day of insertion
The primary outcome will be the patient evaluation of pain during the procedure. The patient will be asked to assess the pain according to VAS scale (10-100 mm) 10 minutes after the insertion of Jaydess intrauterine device.
4 secondary outcomes
Evaluation of pain during menstruation one month after the insertion of Jaydess intrauterine device
Time frame: one month after insertion
Evaluation of pain during menstruation six month after the insertion of Jaydess
Time frame: six month after insertion
Evaluation of the amount of bleeding during menstruation one month after the insertion of Jaydess intrauterine device
Time frame: one month after insertion
Evaluation of the amount of bleeding during menstruation six month after the insertion of Jaydess intrauterine device
Time frame: six month after insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tramadol, Verbal anesthesia and Jaydess in people with IUD Insertion Complication, run by Meir Medical Center.
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 17 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 11 Mar 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluation of pre-insertion therapy (oral analgesia and oral Tramadol) as pain management during insertion of Jaydess measured on a VAS (0-100 mm). (time frame: Day of insertion). 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 11 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.