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

NCT ID: NCT05800392

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-03
• Study Completion Date: 2023-12-01

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

DEC103

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo DEC103

Intervention Type: DRUG

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

Interventions

DEC103

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

Intervention Type: DRUG

Placebo DEC103

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis G Bahamondes, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Research on Reproductive Health of Campinas

Locations

CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas

Campinas, São Paulo, Brazil

Countries

Brazil

Other Identifiers

DEC103-IV-0123

Identifier Type: -

Identifier Source: org_study_id