ClinicalTrials.gov
ClinicalTrials.gov Menu

A Prospective Multicenter Study on Patients'Satisfaction With Angeliq® Micro in Real Clinical Practice Conducted in Russia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03126773
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
To evaluate the patients' satisfaction with Angeliq Micro in real clinical practice after 13 cycles of treatment.

Condition or disease Intervention/treatment
Menopause Drug: BAY86-4891

Detailed Description:

This non-interventional study is planned with the aim of obtaining information about the results of the product use in real clinical practice by means of the evaluation of the patients' satisfaction.

The study will be multicenter, non-interventional, prospective, cohort study in patients for whom their physicians have taken a decision about Angeliq Micro treatment, irrespectively of the fact of this study inclusion.

The absence of a control group (patients who receive another menopausal hormonal therapy medication, or do not receive menopausal hormonal therapy at all) is based on high risk of bias (heterogeneity of exposure in case of comparison of low-dosed and ultralow-doses menopausal hormonal therapy regiments, or in case of comparison with a group of patients for whom the menopausal hormonal therapy is not indicated).


Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Multicenter Non-interventional Cohort Study on Patients'Satisfaction With Angeliq® Micro in Real Clinical Practice Conducted in Russia
Actual Study Start Date : May 5, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Group/Cohort Intervention/treatment
BAY86-4891
The patients will be treated according to the routine practice. All the patients meeting the criteria of inclusion and exclusion to whom administration of Angeliq Micro is indicated are fit for participation in this non-interventional study.
Drug: BAY86-4891
Drospirenone 0.25 mg + estradiol hemihydrate 0.5 mg (Angeliq Micro, G03FA17).Dosage form is one tablet a day.




Primary Outcome Measures :
  1. Patient's satisfaction with the menopausal symptoms treatment after 13 cycles of treatment [ Time Frame: Up to 14 months ]
    Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) will be considered continuous variable and reported using denoted descriptive statistics. Apart from this, patient`s satisfaction will be dichotomised and analysed / reported as "satisfied / not satisfied".


Secondary Outcome Measures :
  1. Patient's satisfaction with the menopausal symptoms treatment after 3-4 cycles of treatment [ Time Frame: Up to 4 months ]
    Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) will be considered continuous variable and reported using denoted descriptive statistics. Apart from this, patient`s satisfaction will be dichotomised and analysed / reported as "satisfied / not satisfied".

  2. Changes in menopause symptoms [ Time Frame: Up to 14 months ]
    Menopause Rating Scale (MRS) questionnaire, will be derived from MRS questionnaire at baseline and at subsequent visits (as difference V2-V1 and V3-V1) and reported using denoted descriptive statistics.

  3. Changes in the quality of life [ Time Frame: Up to 14 months ]
    Menopause Rating Scale (MRS) questionnaire, will be derived from MRS questionnaire at baseline and at subsequent visits (as difference V2-V1 and V3-V1) and reported using denoted descriptive statistics.

  4. Approaches to menopausal hormonal therapy prescription [ Time Frame: Up to 24 months ]
    Approaches to menopausal hormonal therapy prescription will be considered discrete variable and reported using denoted descriptive statistics.

  5. Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy [ Time Frame: Up to 24 months ]
    Reasons of choice of a low-dosed or ultralow-dosed menopausal hormonal therapy will be considered discrete variable and reported using denoted descriptive statistics.

  6. Patients' compliance [ Time Frame: Up to 24 months ]
    Patients' compliance will be considered continuous variable and reported using denoted descriptive statistics.

  7. Number of early discontinuation during the first year of therapy [ Time Frame: Up to 12 months ]
    Early discontinuation during the first year of therapy of Angeliq Micro will be considered binary.

  8. Timing of discontinuation of Angeliq® Micro [ Time Frame: Up to 24 months ]
    Timing of discontinuation of Angeliq Micro will be considered right-censored time-to-event

  9. Reasons of discontinuation of Angeliq Micro [ Time Frame: Up to 24 months ]
    Reasons of discontinuation of Angeliq Micro will be considered multinomial type.

  10. Tolerability of Angeliq Micro in real clinical practice by using MS-TSQ questionnaire [ Time Frame: Up to 24 months ]
    Tolerability of Angeliq Micro will be assessed as question 7 of MS-TSQ questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Female patients aged 50 to 65 years with vasomotor symptoms of menopause
Criteria

Inclusion Criteria:

  • Female patients aged 50 to 65 years with vasomotor symptoms of menopause (moderate or severe in intensity), who has been prescribed or will be prescribed the menopausal hormonal therapy with Angeliq Micro.
  • Patients, who are already receiving continuous combined menopausal hormonal therapy (except Angeliq) for 3-5 years willing to continue MHT, and who will change their therapy for Angeliq Micro.
  • Patients who never ever received menopausal hormonal therapy, if at least 3 years have passed after the last menstruation, with the STRAW+10 stage +1c and younger than 60 years at the moment of inclusion.
  • Signed informed consent form (written consent for the study participation).

Exclusion Criteria:

  • Unwillingness or inability to give the informed consent for the study participation.
  • Contraindications for menopausal hormonal therapy (according to the Angeliq Micro SmPC).
  • Current use or history of use during 1 month before of dietary supplements containing St John's wort, as they can affect tolerability and safety of hormonal therapy.
  • Current participation in any other clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126773


Contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

Locations
Russian Federation
Many locations Recruiting
Multiple Locations, Russian Federation
Sponsors and Collaborators
Bayer

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03126773     History of Changes
Other Study ID Numbers: 19022
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
non-interventional
cohort
Angeliq Micro
menopause
Russia

Additional relevant MeSH terms:
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs