Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT05800392
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT05800392
Study Brief:
Protocol Section:
NCT05800392