An observational study in Menorrhagia, sponsored by Bayer. Completed at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by Bayer · Observational
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.
182 studies on the registry are indexed under Menorrhagia; 33 are open to participants now.
This study's enrollment of 422 is above the median of 300 across 41 observational studies indexed under Menorrhagia.
Browse Menorrhagia studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
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
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
Time frame: Up to 12 months
Overall satisfaction with the chronic hormonal treatment measured with a user satisfaction questionnaire
Time frame: Up to 12 months
Changes in menstrual bleeding pattern measured with a user satisfaction questionnaire
Time frame: Up to 12 months
Correlation between changes in SAMANTA score and changes in women's quality of life measured with SF36v2 questionnaire
SF36v2: Generic health questionnaire, which comprises five dimensions: mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression
Time frame: Up to 12 months
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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