Oral ContraceptionQ-SWANNCT04901377
A Study to Gather Information About User Satisfaction in Women in Russia Who Take Estradiol Valerate/Dienogest
An observational study of Oral Contraception, run by Bayer at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Oral Contraception
- What is being tested?
- Estradiol valerate/ Dienogest
- Type of treatment
- Pill or oral medicine
- How many people
- 255 participants
- Where
- 1 siteRussia
- Study dates
- 24 Jun 2021to 20 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Estradiol valerate/ Dienogest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol valerate/ DienogestCombination product
Also called Qlaira®
Combined hormonal contraceptive (combined oral contraceptives, COCs)
| Study group | Role | What they receive |
|---|---|---|
| Combined oral contraception: Estradiol valerate / Dienogest | Young women (18-35 years of age) using estradiol valerate / dienogest in real clinical practice. Receives: Combination Product: Estradiol valerate/ Dienogest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (6)
Satisfaction rates assessed by physicians
Satisfaction 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.
Measured: up to 6 months
Bleeding profile
The 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).
Measured: up to 6 months
Sexual function using FSFI
Sexual function using "Female Sexual Function Index" (FSFI).
Measured: up to 6 months
Sexual function using ASQ
Sexual 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).
Measured: up to 6 months
Reasons for discontinuation
Measured: up to 6 months
Patient's intentions to continue to take estradiol valerate/ dienogest
yes / no
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start24 Jun 2021
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901377
- Sponsor's protocol ID
- 21768
- Acronym
- Q-SWAN
- Status last verified
- Sep 2023
- First submitted
- 20 May 2021
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04901377
- Acronym / sponsor ID
- Q-SWAN / 21768
- Conditions
- Oral Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined oral contraception: Estradiol valerate / Dienogest | – | Combination Product: Estradiol valerate/ DienogestYoung women (18-35 years of age) using estradiol valerate / dienogest in real clinical practice. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol valerate/ DienogestAlso: Qlaira®Combined hormonal contraceptive (combined oral contraceptives, COCs) | Combination product | Combined oral contraception: Estradiol valerate / Dienogest |
Primary outcome
User satisfaction rates
Time frame: up to 6 months
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.
6 secondary outcomes
Satisfaction rates assessed by physicians
Time frame: up to 6 months
Bleeding profile
Time frame: up to 6 months
Sexual function using FSFI
Time frame: up to 6 months
Sexual function using ASQ
Time frame: up to 6 months
Reasons for discontinuation
Time frame: up to 6 months
Patient's intentions to continue to take estradiol valerate/ dienogest
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Contraception, run by Bayer at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User satisfaction rates (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.