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Completed

NCT Number: NCT05800392

Efficacy and Safety of DEC103 in Pain Control Associated to 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.

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Key information

Conditions

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

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

CEMICAMP - Centro de Pesquisas em Saúde Reprodutiva de Campinas

Campinas, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DEC103

Drug

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

Placebo DEC103

Drug

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

Primary outcomes

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

    Time frame: During the procedure.

    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).

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

    Time frame: During the procedure.

    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).

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

    Time frame: 10 minutes after de procedure.

    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).

Secondary outcomes

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

    Time frame: During the procedure.

    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).

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

    Time frame: During the procedure.

    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

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

    Time frame: Immediately after the procedure.

    Physician's perception will be assessed through a questionnaire with the following options: easy, moderate and difficult.

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study 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

Acronym: DEC103

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 5, 2023
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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