A Study to Gather Information About User Satisfaction in Women in Russia Who Take Estradiol Valerate/Dienogest

NCT04901377 | Completed

• 1 other identifier: 21768
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Contraception

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 6 months

Secondary Outcomes (6)

• Satisfaction rates assessed by physicians

  up to 6 months

• Bleeding profile

  up to 6 months

• Sexual function using FSFI

  up to 6 months

• Sexual function using ASQ

  up to 6 months

• Reasons for discontinuation

  up to 6 months

Study Arms (1)

Combined oral contraception: Estradiol valerate / Dienogest

Young women (18-35 years of age) using estradiol valerate / dienogest in real clinical practice.

Combination Product: Estradiol valerate/ Dienogest

Interventions

Estradiol valerate/ Dienogest COMBINATION_PRODUCT

Combined hormonal contraceptive (combined oral contraceptives, COCs)

Also known as: Qlaira®

Combined oral contraception: Estradiol valerate / Dienogest

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Russia

Location

Related Links

• Click here for access to information about Bayer's transparency standards and Bayer studies

MeSH Terms

Interventions

estradiol valerate-dienogest

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 25, 2021
• Study Start: June 24, 2021
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

RU (1)