SAMIRA: 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

Bayer (Industry)
Overall Status
Completed ID

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chronic hormonal treatment

Study Design

Study Type:
Actual Enrollment :
422 participants
Observational Model:
Time Perspective:
Official Title:
An Observational, Prospective, Multicentre Study to Assess the Sensitivity to Change of the SAMANTA Questionnaire in Women With Heavy Menstrual Bleeding (HMB)
Actual Study Start Date :
Dec 12, 2018
Actual Primary Completion Date :
Mar 12, 2021
Actual Study Completion Date :
May 18, 2021

Arms and Interventions

Arm Intervention/Treatment
Women with HMB

Women with a diagnostic of HMB according to medical criteria and based on clinical judgment that have freely chosen a chronic hormonal treatment under therapeutic indication of HMB in Spain

Drug: Chronic hormonal treatment
Drugs used in this study are described by the physicians during routine gynecological visits
Other Names:
  • 1. Mirena (Levonorgestrel - IUS)
  • 2. Qlaira (Estradiol valerate and dienogest)
  • 3. Progevera (Medroxyprogesterone acetate)
  • and any new hormonal treatment marketed in Spain that has the indication for HMB
  • Outcome Measures

    Primary Outcome Measures

    1. SAMANTA questionnaire score [Up to 12 months]

      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

    Secondary Outcome Measures

    1. Overall satisfaction with the chronic hormonal treatment measured with a user satisfaction questionnaire [Up to 12 months]

    2. Changes in menstrual bleeding pattern measured with a user satisfaction questionnaire [Up to 12 months]

    3. Correlation between changes in SAMANTA score and changes in women's quality of life measured with SF36v2 questionnaire [Up to 12 months]

      SF36v2: Generic health questionnaire, which comprises five dimensions: mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • 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 Criteria:
    • 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).

    Contacts and Locations


    Site City State Country Postal Code
    1 Many locations Multiple Locations Spain

    Sponsors and Collaborators

    • Bayer


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:


    None provided.
    Responsible Party:
    Bayer Identifier:
    Other Study ID Numbers:
    • 20061
    First Posted:
    Nov 23, 2018
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Bayer
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 6, 2022