A Study to Gather Information About User Satisfaction in Women in Russia Who Take Estradiol Valerate/Dienogest
NCT ID: NCT04901377
Last Updated: 2023-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
255 participants
OBSERVATIONAL
2021-06-24
2023-04-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female Subjects
NCT01638910
Bioavailability Study With Oral Single Dose Administration of Ethinylestradiol and Dienogest
NCT01600274
Bioavailability of Dienogest and Ethinyl Estradiol Tablets 2.0 mg/0.03 mg With Regards to Reference Product
NCT04193852
Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding
NCT01638923
Synthetic vs Natural Estrogen in Combined Oral Contraception
NCT02352090
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Combined oral contraception: Estradiol valerate / Dienogest
Young women (18-35 years of age) using estradiol valerate / dienogest in real clinical practice.
Estradiol valerate/ Dienogest
Combined hormonal contraceptive (combined oral contraceptives, COCs)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Estradiol valerate/ Dienogest
Combined hormonal contraceptive (combined oral contraceptives, COCs)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
35 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Many locations
Multiple Locations, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for access to information about Bayer's transparency standards and Bayer studies
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21768
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.