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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT03751800

Collaborator

(none)

422

Enrollment

Location

29.2

Actual Duration (Months)

14.5

Patients Per Site Per Month

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
Menorrhagia	Drug: Chronic hormonal treatment

Study Design

Study Type:

Observational

Actual Enrollment :

422 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 :

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

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

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

Overall satisfaction with the chronic hormonal treatment measured with a user satisfaction questionnaire [Up to 12 months]
Changes in menstrual bleeding pattern measured with a user satisfaction questionnaire [Up to 12 months]
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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

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).