RBR-7phn8yv
Not yet recruiting
Phase 4
Double-blind clinical trial, phase IV, prospective, national, single-center, randomized, to evaluate the efficacy of prophylactic administration of DEC103 compared to placebo in controlling pain associated with the insertion of a Copper Intrauterine Device (TCu380A IUD) or Intrauterine System with Levonorgestrel (LNG-IUS) 52 mg - DEC103-IV0123
Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Unicamp0 sitesNovember 6, 2023
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Pelvic and perineal pain
- Sponsor
- Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Unicamp
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women; with ability to confirm voluntary participation and agree to all the purposes of the trial by signing and dating the Informed Consent Form; age between 18 and 49; participants who will undergo the TCu380A Intrauterine Device (IUD) or LNG 52mg Intrauterine Device (IUD) insertion procedure for the first time; nulliparous women
Exclusion Criteria
- •Any clinical observation finding (clinical/physical evaluation) or laboratory condition that is interpreted by the investigating physician as a risk to the research participant's participation in the clinical trial or presence of uncontrolled chronic disease; chronic pelvic pain of any etiology; abnormality in the uterine cavity; psychiatric disorders; chronic use of medications that interfere with the pain threshold, e.g.: antidepressants and anticonvulsants; use of analgesics and/or anti\-inflammatory drugs in the last 24 hours before the procedure; signs and/or symptoms of vaginal and/or cervical infection; contraindication to the use of Trometamol Ketorolac 10 mg, or Dipyrone Monohydrate \+ Scopolamine Butylbromide \+ Hyoscyamine Hydrobromide \+ Homatropine Methylbromide, 300 mg \+ 6\.5 mcg \+ 104 mcg \+ 1mg; current alcohol or illicit drug use disorder; breastfeeding; participants with known allergy or hypersensitivity to the components of the drugs; participants with a current medical history of cancer and/or treatment for cancer in the last 5 years; participated in clinical trial protocols in the last 12 (twelve) months (CNS Resolution 251, of August 7, 1997, item III, sub\-item J), unless the investigator judges that there may be a direct benefit to the investigator
Outcomes
Primary Outcomes
Not specified
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