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

EMS

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Placebo DEC103; Drug: DEC103

Study type: Interventional

Funder types: Industry

Identifiers

NCT05800392

DEC103-IV-0123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

120 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

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.

Treatment:

Drug: DEC103

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo DEC103