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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEC103 | Drug | The intervention is composed by two medications: An active sublingual pill and an active oral one. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 10 minutes after de procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During the procedure. |
| Women's overall pain perception during the procedure assessed by a 4-point scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis G Bahamondes, MD | Center for Research on Reproductive Health of Campinas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas | Campinas | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo DEC103 | Drug | The intervention is composed by two medications: A placebo sublingual pill and an placebo oral one. |
|
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 |
| 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. | Immediately after the procedure. |