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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 422 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Menorrhagia

Interventions

Type	Name	Description
DRUG	Chronic hormonal treatment	Drugs used in this study are described by the physicians during routine gynecological visits

Timeline

• Start date: 2018-12-12
• Primary completion: 2021-03-12
• Completion: 2021-05-18
• First posted: 2018-11-23
• Last updated: 2024-10-18

Locations

1 site across 1 country: Spain