MenorrhagiaSAMIRANCT03751800
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 study of Menorrhagia, run by Bayer at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Chronic hormonal treatment
- How many people
- 422 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2018to 18 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational, Prospective, Multicentre Study to Assess the Sensitivity to Change of the SAMANTA Questionnaire in Women With Heavy Menstrual Bleeding (HMB)
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
- Being tested
- Chronic hormonal treatment
- Keywords
- Heavy Menstrual Bleeding
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic hormonal treatmentDrug
Also called 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
Drugs used in this study are described by the physicians during routine gynecological visits
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Chronic hormonal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12 months
Secondary outcomes (3)
Overall satisfaction with the chronic hormonal treatment measured with a user satisfaction questionnaire
Measured: Up to 12 months
Changes in menstrual bleeding pattern measured with a user satisfaction questionnaire
Measured: 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
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start12 Dec 2018
- Primary completion12 Mar 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751800
- Sponsor's protocol ID
- 20061
- Acronym
- SAMIRA
- Status last verified
- Oct 2024
- First submitted
- 21 Nov 2018
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36576860
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective, Multicentre Study to Assess the Sensitivity to Change of the SAMANTA Questionnaire in Women With Heavy Menstrual Bleeding (HMB)
- ClinicalTrials.gov ID
- NCT03751800
- Acronym / sponsor ID
- SAMIRA / 20061
- Conditions
- Menorrhagia
- Keywords
- Heavy Menstrual Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with HMB | – | Drug: Chronic hormonal treatmentWomen 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic hormonal treatmentAlso: 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 HMBDrugs used in this study are described by the physicians during routine gynecological visits | Drug | Women with HMB |
Primary outcome
SAMANTA questionnaire score
Time frame: 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
3 secondary outcomes
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
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Results publication: PubMed 36576860Perello-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menorrhagia, run by Bayer at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAMANTA questionnaire score (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03751800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024; AzTrials last refreshed its copy on 27 Oct 2026.