Trials / Completed
CompletedNCT05800392
Efficacy and Safety of DEC103 in Pain Control Associated to Intrauterine Device (IUD) Insertion
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- EMS · Industry
- Sex
- Female
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DEC103 | The intervention is composed by two medications: An active sublingual pill and an active oral one. |
| DRUG | Placebo DEC103 | The intervention is composed by two medications: A placebo sublingual pill and an placebo oral one. |
Timeline
- Start date
- 2023-09-03
- Primary completion
- 2023-12-01
- Completion
- 2023-12-01
- First posted
- 2023-04-05
- Last updated
- 2024-02-20
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT05800392. Inclusion in this directory is not an endorsement.