check_circleStudy Completed
Oral contraception
Bayer Identifier:
21768
ClinicalTrials.gov Identifier:
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
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
FemaleAge
18 - 35 YearsTrial summary
Enrollment Goal
255Trial Dates
June 2021 - April 2023Phase
Phase 4Could I Receive a placebo
NoProducts
Natazia/Qlaira (EV/DNG, BAY86-5027)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Many locations | Many locations, Russia |
Primary Outcome
- User satisfaction ratesUser 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 physiciansSatisfaction 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 profileThe 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 FSFISexual function using «Female Sexual Function Index» (FSFI).date_rangeTime Frame:up to 6 months
- Sexual function using ASQSexual 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 discontinuationdate_rangeTime Frame:up to 6 months
- Patient’s intentions to continue to take estradiol valerate/ dienogestyes / nodate_rangeTime Frame:up to 6 months
Trial design
Trial Type
ObservationalIntervention Type
Combination ProductTrial Purpose
PreventionAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A