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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
The intervention is composed by two medications: An active sublingual pill and an active oral one.
The intervention is composed by two medications: A placebo sublingual pill and an placebo oral one.
CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas
Campinas, São Paulo, Brazil
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).
Time frame: 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).
Time frame: 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).
Time frame: 10 minutes after de procedure.
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).
Time frame: 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
Time frame: During the procedure.
Physician's perception regarding ease of IUD insertion assessed by the following options: easy, moderate and difficult.
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Physician's perception will be assessed through a questionnaire with the following options: easy, moderate and difficult.
Time frame: Immediately after the procedure.