PainPhase 4DEC103NCT05800392
Efficacy and Safety of DEC103 in Pain Control Associated to Intrauterine Device (IUD) Insertion
A Phase 4 study testing DEC103 in people with Pain, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of DEC103 in the pain control associated with IUD insertion in women with 18 to 49 years. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- DEC103
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Sep 2023to 1 Dec 2023
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient has given written informed consent to participate in the study prior to admission;
- Female patients aged between 18 and 49 years old;
- First IUD users;
- Nulliparous women.
Who cannot join
- Any finding or clinical observation (clinical/physical evaluation) or laboratory condition that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical trial or presence of uncontrolled chronic disease(s);
- Presence of chronic pelvic pain and any uterine malformation;
- Presence of psychiatric disorder;
- Chronic use of medications that interfere with the pain threshold, for example: antidepressants and anticonvulsants;
- Use of analgesics and/or ant-inflammatory in the last 24 hours prior the procedure;
- Any sign or symptom of vaginal or cervical infection;
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- Participants with any contraindication to one or both medicines that constitute the DEC103 treatment;
- Actual abuse of alcohol or drugs;
- Participants who are nursing;
- Presence of known allergy or hypersensitivity to the components of the drugs used during the clinical trial;
- Participants with a current medical history of cancer and/or cancer treatment in the last five (05) years;
- Participation in a clinical research protocol in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator judges that there may be a direct benefit to it.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas
Campinas, São Paulo
About this study
Official title: A National, Single Center, Randomized, Prospective, Phase IV, Double-blind, Placebo-controlled, Parallel Study to Assess the Efficacy and Safety of DEC103 in the Pain Control Associated With Intrauterine Device (IUD) Insertion
The purpose of this study is to evaluate the efficacy and safety of DEC103 in the pain control associated with IUD insertion in women with 18 to 49 years.
Read the detailed description
The DEC103 treatment is composed by two different medications that are already available in brazilian market. One is a sublingual pill and the other is an oral one. The participants must take 02 (two) pills of the sublingual formulation and 01 (one) of the oral formulation.
- Conditions
- Pain
- Being tested
- DEC103, Placebo DEC103
- Keywords
- Pain, IUD insertion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEC103Drug
The intervention is composed by two medications: An active sublingual pill and an active oral one.
Placebo DEC103Drug
The intervention is composed by two medications: A placebo sublingual pill and an placebo oral one.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | DEC103: The participants will take 02 (two) pills of the sublingual formulation and 01 (one) pill of the oral one, 1 hour prior the IUD insertion. Receives: Drug: DEC103 |
| Placebo | Placebo comparator | PLACEBO DEC103: The participants will take 02 (two) pills of the placebo sublingual formulation and 01 (one) pill of the placebo oral one, 1 hour prior the IUD insertion. Receives: Drug: Placebo DEC103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS.
Mean pain during the IUD insertion procedure during IUD deployment. The pain will be assessed through a Numeric Rating Scale (NRS), numbered from 0 (no pain) to 10 (worst pain possible).
Measured: During the procedure.
Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS.
Mean overall pain rating during the IUD insertion procedure. The pain will be assessed through a Numeric Rating Scale (NRS), numbered from 0 (no pain) to 10 (worst pain possible).
Measured: During the procedure.
Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS.
Mean pain 10 minuts after the IUD insertion The pain will be assessed through a Numeric Rating Scale (NRS), numbered from 0 (no pain) to 10 (worst pain possible).
Measured: 10 minutes after de procedure.
Secondary outcomes (3)
Efficacy of DEC103 in pain associated to IUD insertion assessed by NRS.
Mean pain during tenaculum placement and uterine sounding. The pain will be assessed through a Numeric Rating Scale (NRS), numbered from 0 (no pain) to 10 (worst pain possible).
Measured: During the procedure.
Women's overall pain perception during the procedure assessed by a 4-point scale.
The global pain perception during the procedure will be assessed through a 4-point scale as the following: 0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = intense pain
Measured: During the procedure.
Physician's perception regarding ease of IUD insertion assessed by the following options: easy, moderate and difficult.
Physician's perception will be assessed through a questionnaire with the following options: easy, moderate and difficult.
Measured: Immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start3 Sep 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by EMSThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis G Bahamondes, MD, Principal investigator, Center for Research on Reproductive Health of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800392
- Sponsor's protocol ID
- DEC103-IV-0123
- Acronym
- DEC103
- Status last verified
- Feb 2024
- First submitted
- 9 Mar 2023
- Last updated
- 20 Feb 2024
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Single Center, Randomized, Prospective, Phase IV, Double-blind, Placebo-controlled, Parallel Study to Assess the Efficacy and Safety of DEC103 in the Pain Control Associated With Intrauterine Device (IUD) Insertion
- ClinicalTrials.gov ID
- NCT05800392
- Acronym / sponsor ID
- DEC103 / DEC103-IV-0123
- Conditions
- Pain
- Keywords
- Pain, IUD insertion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 5 Apr 2023 (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 purpose of this study is to evaluate the efficacy and safety of DEC103 in the pain control associated with IUD insertion in women with 18 to 49 years.
Detailed description
The DEC103 treatment is composed by two different medications that are already available in brazilian market. One is a sublingual pill and the other is an oral one. The participants must take 02 (two) pills of the sublingual formulation and 01 (one) of the oral formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: DEC103DEC103: The participants will take 02 (two) pills of the sublingual formulation and 01 (one) pill of the oral one, 1 hour prior the IUD insertion. |
| Placebo | Placebo comparator | Drug: Placebo DEC103PLACEBO DEC103: The participants will take 02 (two) pills of the placebo sublingual formulation and 01 (one) pill of the placebo oral one, 1 hour prior the IUD insertion. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient has given written informed consent to participate in the study prior to admission;
- Female patients aged between 18 and 49 years old;
- First IUD users;
- Nulliparous women.
Key exclusion criteria (12 listed)
- Any finding or clinical observation (clinical/physical evaluation) or laboratory condition that is interpreted by the investigating physician as a risk to the participation of the research participant in the clinical trial or presence of uncontrolled chronic disease(s);
- Presence of chronic pelvic pain and any uterine malformation;
- Presence of psychiatric disorder;
- Chronic use of medications that interfere with the pain threshold, for example: antidepressants and anticonvulsants;
- Use of analgesics and/or ant-inflammatory in the last 24 hours prior the procedure;
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 |
|---|---|---|
| DEC103The intervention is composed by two medications: An active sublingual pill and an active oral one. | Drug | Experimental |
| Placebo DEC103The intervention is composed by two medications: A placebo sublingual pill and an placebo oral one. | Drug | Placebo |
Primary outcome
Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS.
Time frame: During the procedure.
Mean pain during the IUD insertion procedure during IUD deployment. The pain will be assessed through a Numeric Rating Scale (NRS), numbered from 0 (no pain) to 10 (worst pain possible).
Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS.
Time frame: During the procedure.
Mean overall pain rating during the IUD insertion procedure. The pain will be assessed through a Numeric Rating Scale (NRS), numbered from 0 (no pain) to 10 (worst pain possible).
Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS.
Time frame: 10 minutes after de procedure.
Mean pain 10 minuts after the IUD insertion The pain will be assessed through a Numeric Rating Scale (NRS), numbered from 0 (no pain) to 10 (worst pain possible).
3 secondary outcomes
Efficacy of DEC103 in pain associated to IUD insertion assessed by NRS.
Time frame: During the procedure.
Women's overall pain perception during the procedure assessed by a 4-point scale.
Time frame: During the procedure.
Physician's perception regarding ease of IUD insertion assessed by the following options: easy, moderate and difficult.
Time frame: Immediately after the procedure.
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 Feb 2024.
- 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.
Luis G Bahamondes, MD principal investigator
Center for Research on Reproductive Health of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DEC103 in people with Pain, run by EMS at 1 site in Brazil.
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 4 inclusion and 12 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 Feb 2024. 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 Brazil. 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 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?
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?
Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS. (time frame: During the procedure.). The study lists 3 primary outcomes in all. 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 Feb 2024.