Clinical trial NCT04901377: A Study to Gather Information About User Satisfaction in Women in Russia Who Take Estradiol Valerate/Dienogest
Official title: A Prospective Multicenter Non-interventional Study to Evaluate User Satisfaction With Estradiol Valerate/ Dienogest in Real Clinical Practice to be Conducted in Russia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-05-25
Enrollment: 255
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
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.

Brief 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


Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: User satisfaction rates
timeFrame: up to 6 months
Secondary outcomes:
measure: Satisfaction rates assessed by physicians
timeFrame: up to 6 months
measure: Bleeding profile
timeFrame: up to 6 months
measure: Sexual function using FSFI
timeFrame: up to 6 months
measure: Sexual function using ASQ
timeFrame: up to 6 months
measure: Reasons for discontinuation
timeFrame: up to 6 months
measure: Patient's intentions to continue to take estradiol valerate/ dienogest
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Multiple Locations
country: Russian Federation
facility: Many locations
Study officials:
References: