check_circleStudy Completed

Menorrhagia

Bayer Identifier:

20061

ClinicalTrials.gov Identifier:

NCT03751800

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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 women with HMB who are treated during 12 months with a chronic hormonal treatment. Patients that are treated with chronic hormonal treatment as Levonorgestrel (trade name Mirena) or with a combination of estradiol valerate and dienogest (trade name Qlaira) or with Medroxyprogesterone acetate (trade name Progevera) and any new hormonal treatment marketed in Spain that has the indication for HMB in routine gynaecological practice are observed for 12 months in this study or for a shorter period in time in case of withdrawal. The study aims also to describe the overall satisfaction of women with their chronic hormonal treatment for HMB and how the women think their menstrual bleeding has changed. In addition the study aims to describe the changes of the score that is derived from the SAMANTA questionnaire in relation to Quality of Life. Quality of Life is measured with the SF36v2 questionnaire. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - 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.
  • - 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).

Trial summary

Enrollment Goal
422
Trial Dates
December 2018 - May 2021
Phase
Phase 4
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Spain

Primary Outcome

  • SAMANTA questionnaire score
    SAMANTA questionnaire: is a existing and validated tool has shown that it can be effectively used by gynaecologists to easily discriminate among women with and without HMB
    date_rangeTime Frame:
    Up to 12 months

Secondary Outcome

  • Overall satisfaction with the chronic hormonal treatment measured with a user satisfaction questionnaire
    date_rangeTime Frame:
    Up to 12 months
  • Changes in menstrual bleeding pattern measured with a user satisfaction questionnaire
    date_rangeTime Frame:
    Up to 12 months
  • Correlation between changes in SAMANTA score and changes in women’s quality of life measured with SF36v2 questionnaire
    SF36v2: Generic health questionnaire, which comprises five dimensions: mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression
    date_rangeTime Frame:
    Up to 12 months

Trial design

An observational, prospective, multicentre study to assess the sensitivity to change of the SAMANTA questionnaire in women with heavy menstrual bleeding (HMB)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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