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

NCT05800392 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-02-20

No results posted yet for this study

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

Interventions

DRUG

DEC103

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

DRUG

Placebo DEC103

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

Sponsors & Collaborators

  • EMS

    lead INDUSTRY

Principal Investigators

  • Luis G Bahamondes, MD · Center for Research on Reproductive Health of Campinas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-03
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05800392 on ClinicalTrials.gov