Status:
COMPLETED
A Study Run At Multiple Study Sites to Test Whether the SAMANTA Questionnaire That is Used to Diagnose Heavy Menstrual Bleeding (HMB), Can Also Be Used to Assess Changes of Severity of HMB in Women with HMB Who Are Treated During 12 Months with a Chronic Hormonal Treatment
Lead Sponsor:
Bayer
Conditions:
Menorrhagia
Eligibility:
FEMALE
18+ years
Brief Summary
A study run at multiple study sites in Spain to test whether the SAMANTA questionnaire that is used to diagnose heavy menstrual bleeding (HMB), can also be used to assess changes of severity of HMB in...
Eligibility Criteria
Inclusion
- Women in childbearing age, ≥18 years old, not intending to become pregnant during the next year.
- Women diagnosed with heavy menstrual bleeding or idiopathic menorrhagia according to medical criteria and based on clinical judgment.
- Women for whom the clinician decides, in agreement with the patient, to prescribe any of the available chronic hormonal treatments with the therapeutic indication of HMB in Spain (Mirena, Qlaira or Progevera).
- Women capable of reading and writing.
- Women who signed the informed consent.
Exclusion
- Women with amenorrhea or menopause.
- Women with contraindications and warnings with the chronic hormonal treatment prescribed for HMB as per the summary of product characteristics (interaction with concomitant medication, etc.).
- Women receiving contraceptive hormonal therapy or using a copper intrauterine device.
- Women on hormone replacement therapy.
- Women with a history of malignancy.
- Women with degenerative diseases that could directly negatively impact their daily life.
- Women who have given birth within the previous 6 months.
- Women who are pregnant.
- Women participating in an investigational program with interventions outside of routine clinical practice.
- Women with psychiatric disorders who are unable to make decisions and follow instructions.
- Women with concomitant medication that may lead to changes in the bleeding pattern (e.g. antiplatelet and/ or anticoagulants).
Key Trial Info
Start Date :
December 12 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 18 2021
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT03751800
Start Date
December 12 2018
End Date
May 18 2021
Last Update
October 18 2024
Active Locations (1)
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1
Many locations
Many Locations, Spain