Clinical trial 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
Official title: An Observational, Prospective, Multicentre Study to Assess the Sensitivity to Change of the SAMANTA Questionnaire in Women with Heavy Menstrual Bleeding (HMB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menorrhagia
Keywords: Heavy Menstrual Bleeding
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-11-23
Enrollment: 422
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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).

Primary outcomes:
measure: SAMANTA questionnaire score
timeFrame: Up to 12 months
Secondary outcomes:
measure: Overall satisfaction with the chronic hormonal treatment measured with a user satisfaction questionnaire
timeFrame: Up to 12 months
measure: Changes in menstrual bleeding pattern measured with a user satisfaction questionnaire
timeFrame: Up to 12 months
measure: Correlation between changes in SAMANTA score and changes in women's quality of life measured with SF36v2 questionnaire
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Many locations
country: Spain
facility: Many locations
Study officials:
References:
citation: Perello-Capo J, Rius-Tarruella J, Andeyro-Garcia M, Calaf-Alsina J. Sensitivity to Change of the SAMANTA Questionnaire, a Heavy Menstrual Bleeding Diagnostic Tool, After 1 Year of Hormonal Treatment. J Womens Health (Larchmt). 2023 Feb;32(2):208-215. doi: 10.1089/jwh.2022.0155. Epub 2022 Dec 22.