Efficacy and Safety of DEC103 in Pain Control Associated to Intrauterine Device (IUD) Insertion (DEC103)

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: DEC103; Drug: Placebo DEC103

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Campinas, SP, Brazil
      • CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: DEC103; The intervention is composed by two medications: An active sublingual pill and an active oral one.
Placebo Comparator: Placebo; 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.	Drug: Placebo DEC103; The intervention is composed by two medications: A placebo sublingual pill and an placebo oral one.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: EMS
• Investigators: Principal Investigator: Luis G Bahamondes, MD, Center for Research on Reproductive Health of Campinas

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pain; IUD insertion
• Other Study ID Numbers: DEC103-IV-0123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No