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

NCT05800392 | Completed Phase 4 DMC

• 1 other identifier: DEC103-IV-0123
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain; IUD insertion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Efficacy of DEC103 in pain associated to IUD insertion assessed by NRS.

  During the procedure.

• Women's overall pain perception during the procedure assessed by a 4-point scale.

  During the procedure.

• Physician's perception regarding ease of IUD insertion assessed by the following options: easy, moderate and difficult.

  Immediately after the procedure.

Study Arms (2)

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

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.

Drug: Placebo DEC103

Interventions

DEC103 DRUG

The intervention is composed by two medications: An active sublingual pill and an active oral one.

Experimental

Placebo DEC103 DRUG

The intervention is composed by two medications: A placebo sublingual pill and an placebo oral one.

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas

Campinas, São Paulo, Brazil

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis G Bahamondes, MD

  Center for Research on Reproductive Health of Campinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 5, 2023
• Study Start: September 3, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)