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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: DEC103 (Drug)
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.
干预措施: Placebo DEC103 (Drug)
结局指标
主要结局
Efficacy of DEC103 in pain management associated to IUD insertion assessed by NRS.
时间窗: 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).
次要结局
- 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.)