A Study to Gather Information About User Satisfaction in Women in Russia Who Take Estradiol Valerate/Dienogest
Condition: Oral Contraception
Study type: Observational

Summary: 
      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
    


Intervention name(s): Estradiol valerate/ Dienogest
Intervention type(s): Combination Product
Intervention description(s): Combined hormonal contraceptive (combined oral contraceptives, COCs)
Other intervention name(s): Qlaira®
Intervention MeSH terms: Dienogest; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women 18 to 35 years of age who elect to use oral contraceptives will be enrolled after the
        decision for administration of estradiol valerate/ dienogest has been made by the
        physician.