check_circleStudy Completed

Oral contraception

Bayer Identifier:

21768

ClinicalTrials.gov Identifier:

NCT04901377

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study to gather information about user satisfaction in women in Russia who take estradiol valerate/dienogest

Trial purpose

Researchers want to learn more about user satisfaction in women in Russia who take estradiol valerate/ dienogest as a contraceptive in real conditions.
Estradiol valerate/ dienogest is a form of birth control. This is also known as a combined oral contraceptive (COC). Earlier studies showed that estradiol valerate/ dienogest has high level of protection from unplanned pregnancy. It is available for doctors to prescribe to women who want to take an oral contraceptive.
Estradiol valerate/ dienogest as a combined oral contraceptive (COC), works by stopping a process called ovulation. This is the process by which the ovaries release an egg. COCs are commonly used by young women to prevent pregnancy.
The researchers in this study will collect information from young women (18-35 years of age) in Russia who will start taking estradiol valerate/ dienogest.
The main purpose of this study is to find out about the women’s satisfaction with taking estradiol valerate/ dienogest. To do this, the researchers will ask “how satisfied are you with the birth control method used during the study?”. They will ask this question after the women have taken estradiol valerate/ dienogest for 3 and 6 months. The women willanswer this question using a rating scale ranging from 1 to 5, with 1 meaning “very dissatisfied” and 5 meaning “very satisfied”.

This study will include young women (18-35 years of age) who want to use oral contraceptives and have been prescribed estradiol valerate/ dienogest by their doctor. None of the women in the study will have taken estradiol valerate/ dienogest within 1 month of joining the study.
In this study, it is expected that each woman will visit her study site 3 times. Each woman will be in the study for up to 6 months. All of the women will take estradiol valerate/ dienogest as prescribed by their doctors. There will be no other required procedures or treatments in this study which is not be used in usual practice.
During the study, the women will answer a question about how satisfied they are with estradiol valerate/ dienogest. They will also respond to some questionnaires. These will include a questionnaire about their menstrual bleeding patterns, sexual function. The doctors will:
•   ask the women about any medical conditions they may have and what other contraceptives they took before they joined the study
•   check the women’s blood pressure and pulse rate
•   ask a question about woman’s intention to continue to use estradiol valerate/ dienogest and the reasons for discontinuation of estradiol valerate/ dienogest if it has happened

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - Age from 18 to 35 y.o.
    - Indications for administration of estradiol valerate/ dienogest for the purpose of oral contraception.
    - Patients who did not take estradiol valerate/ dienogest for at least one month before enrollment into the study.
    - Signed informed consent to participate in the study

    Exclusion criteria
    - Participation in an investigational program with interventions outside of routine clinical practice.
    - Contraindications to estradiol valerate/ dienogest according to the local market authorization.
    - Any medical and non-medical reasons that according to the physician’s judgment may prevent patient’s participation in
    the non-interventional study.

Trial summary

Enrollment Goal
255
Trial Dates
June 2021 - April 2023
Phase
Phase 4
Could I Receive a placebo
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many locationsMany locations, Russia

Primary Outcome

  • User satisfaction rates
    User satisfaction rates assessed by subjects using an overall satisfaction rating (5-point Likert item) with the following question: “How satisfied are you with the birth control method used during the study?” Answers include: 1 - very dissatisfied; 2 - dissatisfied; 3 - neither satisfied nor dissatisfied; 4 - satisfied; 5 - very satisfied. Subjects selecting answers #4 or #5 (i.e., subjects expressing satisfaction) will count toward the overall satisfaction rate.
    date_rangeTime Frame:
    up to 6 months

Secondary Outcome

  • Satisfaction rates assessed by physicians
    Satisfaction rates assessed by physicians using an overall satisfaction rating (5-point Likert item) with the following question: “How satisfied are you with the birth control method used during the study?” Answers include: 1 - very dissatisfied; 2 - dissatisfied; 3 - neither satisfied nor dissatisfied; 4 - satisfied; 5 - very satisfied. Physicians selecting answers #4 or #5 (i.e., physicians expressing satisfaction) will count toward the overall satisfaction rate.
    date_rangeTime Frame:
    up to 6 months
  • Bleeding profile
    The bleeding profile during the previous 3 months and during therapy (visits 2,3), self-reported: regularity (regular, periodically absent, permanently absent); maximum bleeding duration (1-2 days, 3-5 days, 6-7 days, 8 days and more); maximum bleeding intensity (spotting, light bleeding, normal bleeding, heavy bleeding); painful bleeding (yes/ no); inter-menstrual bleeding (yes/ no).
    date_rangeTime Frame:
    up to 6 months
  • Sexual function using FSFI
    Sexual function using «Female Sexual Function Index» (FSFI).
    date_rangeTime Frame:
    up to 6 months
  • Sexual function using ASQ
    Sexual function using Atrophy Symptom Questionnaire (ASQ): dryness; sensitivity; irritation; dyspareunia; vaginal discharge (each symptom will be assessed with the following scale: 0 - normal, 1 - mild, 2 - moderate, 3 – severe).
    date_rangeTime Frame:
    up to 6 months
  • Reasons for discontinuation
    date_rangeTime Frame:
    up to 6 months
  • Patient’s intentions to continue to take estradiol valerate/ dienogest
    yes / no
    date_rangeTime Frame:
    up to 6 months

Trial design

A prospective multicenter non-interventional study to evaluate user satisfaction with estradiol valerate/ dienogest in real clinical practice to be conducted in Russia
Trial Type
Observational
Intervention Type
Combination Product
Trial Purpose
Prevention
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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