Clinical trial NCT05800392: Efficacy and Safety of DEC103 in Pain Control Associated to Intrauterine Device (IUD) Insertion
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Pain
IUD insertion
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2023-04-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS.
timeFrame: During the procedure.
measure: Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS.
timeFrame: During the procedure.
measure: Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS.
timeFrame: 10 minutes after de procedure.
Secondary outcomes:
measure: Efficacy of DEC103 in pain associated to IUD insertion assessed by NRS.
timeFrame: During the procedure.
measure: Women's overall pain perception during the procedure assessed by a 4-point scale.
timeFrame: During the procedure.
measure: Physician's perception regarding ease of IUD insertion assessed by the following options: easy, moderate and difficult.
timeFrame: Immediately after the procedure.
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas
state: SP
Study officials:
affiliation: Center for Research on Reproductive Health of Campinas
name: Luis G Bahamondes, MD
role: PRINCIPAL_INVESTIGATOR
References: