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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 (SAMIRA)

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ClinicalTrials.gov Identifier: NCT03751800
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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
Menorrhagia Drug: Chronic hormonal treatment

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Study Type : Observational
Estimated Enrollment : 452 participants
Observational Model: Cohort
Time Perspective: Prospective
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 : December 12, 2018
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women in childbearing age, with diagnosed HMB according to medical criteria and based on clinical judgment and for whom the clinician decides, in agreement with the patient, to prescribe a chronic hormonal treatment with the therapeutic indication of HMB or idiopathic menorrhagia (IM) in Spain during a routine gynaecological visit.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751800


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Spain
Many locations Recruiting
Multiple Locations, Spain
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03751800     History of Changes
Other Study ID Numbers: 20061
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Heavy Menstrual Bleeding
Additional relevant MeSH terms:
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Menorrhagia
Hemorrhage
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Medroxyprogesterone Acetate
Levonorgestrel
Medroxyprogesterone
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents