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NCT Number: NCT03751800

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

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.

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Many locations

Many Locations, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Chronic hormonal treatment

Drug

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

Primary outcomes

  1. SAMANTA questionnaire score

    Time frame: 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 outcomes

  1. Overall satisfaction with the chronic hormonal treatment measured with a user satisfaction questionnaire

    Time frame: Up to 12 months

  2. Changes in menstrual bleeding pattern measured with a user satisfaction questionnaire

    Time frame: Up to 12 months

  3. Correlation between changes in SAMANTA score and changes in women's quality of life measured with SF36v2 questionnaire

    Time frame: Up to 12 months

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

An Observational, Prospective, Multicentre Study to Assess the Sensitivity to Change of the SAMANTA Questionnaire in Women With Heavy Menstrual Bleeding (HMB)

Acronym: SAMIRA

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2018
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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