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

NCT03751800 | Completed

• 1 other identifier: 20061
• Study Type: observational
• Target: 422
• Locations: 1 country
• Sites: 1

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.

Conditions

Menorrhagia

Keywords

Heavy Menstrual Bleeding

Outcome Measures

Primary Outcomes (1)

• SAMANTA questionnaire score

  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

  Up to 12 months

Secondary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Chronic hormonal treatment DRUG

Drugs used in this study are described by the physicians during routine gynecological visits

Also known as: 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

Women with HMB

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Many Locations, Spain

Location

Related Publications (1)

• 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.

  PMID: 36576860 BACKGROUND

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Menorrhagia

Interventions

Estradiol; dienogest; Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 23, 2018
• Study Start: December 12, 2018
• Primary Completion: March 12, 2021
• Study Completion: May 18, 2021
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

ES (1)