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Efficacy and Safety of DEC103 in Pain Control for IUD Insertion
NCT05800392Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2023
- Primary completion
- Dec 2023
- Countries
- 1
- Sponsor
- EMS
- Modality
- Nucleic Acid-Directed Small Molecules, Covalent Small Molecules, Classical Binding Small Molecules
- Conditions
- procedural pain
01
Overview
Phase 4, randomised, double-blind trial of ketorolac, Metamizole sodium, scopolamine, hyoscyamine and homatropine in procedural pain (2 arms), sponsored by EMS. Primary endpoint: Efficacy of DEC103 in pain management associated to IUD insertion assessed by Numeric Rating Scale (NRS). Started Sep 2023; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Experimental: DEC103
2 sublingual pills (Ketorolac) + 1 oral pill (Dipyrone/Scopolamine/Hyoscyamine/Homatropine)
Placebo: DEC103
Placebo pills matching the experimental regimen
03
Who it enrols
First IUD users, nulliparous women aged 18 to 49 years.
04
Endpoints
Primary
Efficacy of DEC103 in pain management associated to IUD insertion assessed by Numeric Rating Scale (NRS)
Secondary
Women's overall pain perception
Physician's perception regarding ease of IUD insertion
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