Vaginal AtrophyEIC01-PMCFNCT04910906
Non-Interventional Multicentre Post-market Study of Ectoin® Vaginal Gel for Symptomatic Treatment of Vaginal Atrophy
An observational study of Vaginal Atrophy, run by Bitop AG at 1 site in Germany.
Trial summary
The goal of this multi-centre, prospective, open label, single arm, observational post-market clinical follow-up study (§23b of the MPG (German Medical Act) MDD 93/42/EEC and ISO14155:2020) is to investigate and evaluate the clinical efficacy of Ectoin® Vaginal gel (EIC01) to retain/restore the natural moisturization… Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- Ectoin® Vaginal Gel
- Type of treatment
- Medical device
- How many people
- 155 participants
- Where
- 1 siteGermany
- Study dates
- 3 May 2021to 9 Feb 2022
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: post-menopausal women of 50 years or above with no menstruation > 12 months and self-reporting/complaining of vaginal atrophy symptoms. Vaginal atrophy (VA) is a condition occurring due to the deteriorating structural and functional integrity of the vulvovaginal epithelium. It is commonly observed in menopausal and post-menopausal women and associated with an increased feeling of vaginal dryness and frequent/persistent irritation (burning sensation and pruritus) and pain on penetration (dyspareunia) in the vagina. VA also results in cytomorphological changes of the vaginal mucosa; however, it is the vulvovaginal symptoms associated with VA which are considered most bothersome, such as dryness, itching, burning sensation, and dyspareunia (pain during sexual penetration).
Who may be able to join
- Menopausal women 50 years of age or older with no menstruation for at least 12 months.
- Self-reported vaginal atrophy symptoms and presence of all 4 common vaginal atrophy symptoms i.e., feeling of vaginal dryness, itching, burning sensation and dyspareunia.
- Sexually active women.
- Vaginal atrophy clinically confirmed through physical examination of vagina and vaginal pH; pH ≥ 5 and VHI ≤ 15.
- Patient who qualifies for Ectoin® Vaginal Gel treatment according to the approved indication and in physician's opinion the participant will benefit from this treatment.
- Signed informed consent.
- Willingness of the participants to actively participate in the study and to come to the scheduled visits.
- Willingness of the participants to continue the application of EIC01 in the test area throughout the course of the study and to avoid forbidden treatment.
Who cannot join
- Women reporting systemic post-menopausal symptoms (eg. hot flushes, sleep disturbances, slowed metabolism etc.) in addition to clinically confirmed vaginal atrophy.
- Women who had not performed a cervical cytology in the last year to rule out underlying critical condition.
- Vaginal infections (in past 8 weeks)
- Women taking systemic hormone replacement or pills within last 6 months.
- Patients with concomitant clinically important medical disease according to the investigator's opinion that might interfere with patient safety or evaluation of study results; that includes but not limited to endometrial hyperplasia or cancer; undiagnosed vaginal bleeding; liver or kidney disorder; thromboembolic disorders; cerebrovascular accident, stroke, or transient ischemic attack; myocardial infarction or ischemic heart disease; malignancy; endocrine disease or any clinically important abnormalities on (if any) screening physical examination, mammogram, electrocardiogram (ECG), or laboratory tests (indicative of any vaginal infection).
- Participation in any other clinical study within the last 4 weeks prior to the baseline visit.
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- Previous incident or knowledge of possible hypersensitivity or allergic reactions to any of the components of EIC01.
- Previous treatment with other local non-hormonal moisturisers/hormonal products within 1 month or use of lubricants within 1 week prior to inclusion.
- Treatment with systemic medications for other non-related health condition which might impact the study results e.g. glucocorticosteroids, antibiotics etc. which has the potential to bring about change in vaginal environment.
- Medical or mental condition for which in the opinion of the physician, patient will not be able to fulfil questionnaires independently or to adhere to instructions and procedures in accordance with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Post-market Clinical Follow up Study to Assess Efficacy and Safety of Ectoin® Vaginal Gel (EIC01) for Symptomatic Treatment of Vaginal Atrophy in Post-menopausal Women
The goal of this multi-centre, prospective, open label, single arm, observational post-market clinical follow-up study (§23b of the MPG (German Medical Act) MDD 93/42/EEC and ISO14155:2020) is to investigate and evaluate the clinical efficacy of Ectoin® Vaginal gel (EIC01) to retain/restore the natural moisturization in the vaginal lumen and to alleviate vaginal atrophy symptoms.
Read the detailed description
A multi-centre, prospective, open label, single arm, observational post-market clinical follow-up study according to §23b of the MPG (German Medical Act) and conforming to MDD 93/42/EEC and ISO14155:2020.
Study participation will be offered to patients with symptoms of vaginal atrophy for which Ectoin® Vaginal Gel is indicated. Screening period might take up to 14 days. If the patient, at the screening visit, complies with all the inclusion criteria (except inclusion criterion No. 4 which is to be confirmed at the Baseline Visit) and she has signed the informed consent, she will be enrolled, and baseline visit will be performed on the same day.
The Ectoin® Vaginal Gel will be used for 20 days and in accordance with the IFU . Visits are scheduled on day 1, 5, and 20, at which the treatment is ended (End of treatment - EoT). Follow-up (FU) visit is planned on Day 23. Patient will record her symptoms and number of applied doses in the patient diary on daily basis, preferably around a specific time which has to be followed throughout the entire study period. Overall, participation will take at least 23 (+2) days and 37 (+2) days at maximum. The enrolment period will take 2 months. The total duration of the study is expected to be approximately 3-6 months.
The efficacy and safety of Ectoin® Vaginal Gel (EIC01) in the alleviation of vaginal atrophy symptoms will be evaluated in this study. Efficacy will be evaluated based on the improvement of Vaginal Atrophy symptoms at post-treatment measurements as compared to baseline values.
Primary endpoint is to evaluate the efficacy of the EIC01 product by analysing the difference in the sum scores of Vaginal Health Index (VHI) indicating both subjective and objective improvement in the vaginal atrophy condition after multiple application.
Secondary Endpoint:
- Improvement in individual and sum score of VAS for vaginal atrophy symptoms (feeling of dryness, itching, burning, pain during sexual intercourse) after single (immediate effect) and multiple applications
- Assessment of vaginal atrophy impact on life through Q/A
- Assessment of product acceptance and overall satisfaction through Q/A (on 20 day - V2) • Long-term treatment effect based on rate of improvement compared to baseline condition determined by subjective and objective assessments (5 days, 20 days and 23 days).
- Long-lasting effect assessed during follow-up by subjective and objective assessments on day 23.
- The treatment safety will be assessed by observation and documentation of adverse events and device deficiencies.
- Local tolerability will be assessed both by physician and patient using five-point scale (excellent, good, moderate, poor, bad).
- Conditions
- Vaginal Atrophy
- Being tested
- Ectoin® Vaginal Gel
- Keywords
- vaginal atrophy, vaginal dryness, post-menopausal symptoms, post-menopausal Vaginal health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ectoin® Vaginal GelDevice
Ectoin® Vaginal Gel is a clear, non-hormonal moisturizing gel containing only active ingredient Ectoin® for the relief of vaginal dryness/vaginal atrophy.
Other excipients in the formulation include:
Hydroxyethylcellulose (Gelling agent) Lactic acid (90 %) (pH stabiliser) DL-Sodium lactate (Buffer substance) Sodium benzoate (preservative) Propylene glycol (Humectant)
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vaginal Health Index (VHI) Score
Assessment of vaginal lumen condition by gynaecologist from baseline to end of study on 20th day of application and thereafter, follow-up assessment in 3-5 days from end of treatment. The VHI components are graded from 1-5; where 1 indicating worst possible and 5 indicating best possible conditions.
Measured: treatment 20 days + FU 3 to 5 days
Secondary outcomes (7)
Change in vaginal pH
Descriptive account of the vaginal pH as determined by the investigator during the visits using pH indicator strips of range 4.0 -7.0 pH
Measured: 20+ (3-5) days FU
Change in severity of VA symptoms (vaginal irritation, itching, vaginal dryness, and dyspareunia)
Patient reported outcome on a VAS scare graded from 0-10; 0 = no problem and 10 = extremely unbearable
Measured: 20+ (3-5) days FU
Change in total score in Quality of Life evaluation parameters
MCQ (multiple choice questions) format to choose the answer that corresponds best to the patient's situation. Patient have to choose between 4 options defining varying state possible outcome relevant to each specific question.
Measured: 20+ (3-5) days FU
Change in score of overall vaginal atrophy condition
Patient reported outcome on a VAS scare graded from 0-10; 0 = no problem and 10= extremely unbearable
Measured: 20+ (3-5) days FU
Change in score of symptoms based rating on need for treatment
Patient reported outcome on a VAS scare graded from 0-10; 0 = no at all and 10 = extreme need
Measured: 20+ (3-5) days FU
Overall tolerability assessments
tolerability assessments (investigator and/or patient) on a 5-point scale;
1 = excellent (no reaction), 2 = good (small reaction that spontaneously resolves), 3 = moderate (reaction tolerated with difficulty by the subject), 4 = poor (reaction needing interruption of treatment), 5 = bad (serious reaction)
Measured: 20 days
Number of AEs and assessment of intensity, causality and seriousness of Adverse Events
The adverse events will be classified as non-serious adverse event or serious adverse event (SAE), the intensity will be graded as mild, moderate, severe, life threatening or fatal. The causality will be classified as definitely, probably, possibly, or not related and in case of none of the above should be defined as an unknown relationship.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start3 May 2021
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal AtrophyStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shatadal Sen, MSc., Study chair, Project Manager (Medical Device Development)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910906
- Sponsor's protocol ID
- btph-045-2020-EIC01
- Acronym
- EIC01-PMCF
- Status last verified
- Jul 2023
- First submitted
- 25 May 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post-market Clinical Follow up Study to Assess Efficacy and Safety of Ectoin® Vaginal Gel (EIC01) for Symptomatic Treatment of Vaginal Atrophy in Post-menopausal Women
- ClinicalTrials.gov ID
- NCT04910906
- Acronym / sponsor ID
- EIC01-PMCF / btph-045-2020-EIC01
- Conditions
- Vaginal Atrophy
- Keywords
- vaginal atrophy, vaginal dryness, post-menopausal symptoms, post-menopausal Vaginal health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 2 Jun 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.
The goal of this multi-centre, prospective, open label, single arm, observational post-market clinical follow-up study (§23b of the MPG (German Medical Act) MDD 93/42/EEC and ISO14155:2020) is to investigate and evaluate the clinical efficacy of Ectoin® Vaginal gel (EIC01) to retain/restore the natural moisturization in the vaginal lumen and to alleviate vaginal atrophy symptoms.
Detailed description
A multi-centre, prospective, open label, single arm, observational post-market clinical follow-up study according to §23b of the MPG (German Medical Act) and conforming to MDD 93/42/EEC and ISO14155:2020.
Study participation will be offered to patients with symptoms of vaginal atrophy for which Ectoin® Vaginal Gel is indicated. Screening period might take up to 14 days. If the patient, at the screening visit, complies with all the inclusion criteria (except inclusion criterion No. 4 which is to be confirmed at the Baseline Visit) and she has signed the informed consent, she will be enrolled, and baseline visit will be performed on the same day.
The Ectoin® Vaginal Gel will be used for 20 days and in accordance with the IFU . Visits are scheduled on day 1, 5, and 20, at which the treatment is ended (End of treatment - EoT). Follow-up (FU) visit is planned on Day 23. Patient will record her symptoms and number of applied doses in the patient diary on daily basis, preferably around a specific time which has to be followed throughout the entire study period. Overall, participation will take at least 23 (+2) days and 37 (+2) days at maximum. The enrolment period will take 2 months. The total duration of the study is expected to be approximately 3-6 months.
The efficacy and safety of Ectoin® Vaginal Gel (EIC01) in the alleviation of vaginal atrophy symptoms will be evaluated in this study. Efficacy will be evaluated based on the improvement of Vaginal Atrophy symptoms at post-treatment measurements as compared to baseline values.
Primary endpoint is to evaluate the efficacy of the EIC01 product by analysing the difference in the sum scores of Vaginal Health Index (VHI) indicating both subjective and objective improvement in the vaginal atrophy condition after multiple application.
Secondary Endpoint:
- Improvement in individual and sum score of VAS for vaginal atrophy symptoms (feeling of dryness, itching, burning, pain during sexual intercourse) after single (immediate effect) and multiple applications
- Assessment of vaginal atrophy impact on life through Q/A
- Assessment of product acceptance and overall satisfaction through Q/A (on 20 day - V2) • Long-term treatment effect based on rate of improvement compared to baseline condition determined by subjective and objective assessments (5 days, 20 days and 23 days).
- Long-lasting effect assessed during follow-up by subjective and objective assessments on day 23.
- The treatment safety will be assessed by observation and documentation of adverse events and device deficiencies.
- Local tolerability will be assessed both by physician and patient using five-point scale (excellent, good, moderate, poor, bad).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- post-menopausal women of 50 years or above with no menstruation > 12 months and self-reporting/complaining of vaginal atrophy symptoms. Vaginal atrophy (VA) is a condition occurring due to the deteriorating structural and functional integrity of the vulvovaginal epithelium. It is commonly observed in menopausal and post-menopausal women and associated with an increased feeling of vaginal dryness and frequent/persistent irritation (burning sensation and pruritus) and pain on penetration (dyspareunia) in the vagina. VA also results in cytomorphological changes of the vaginal mucosa; however, it is the vulvovaginal symptoms associated with VA which are considered most bothersome, such as dryness, itching, burning sensation, and dyspareunia (pain during sexual penetration).
Key inclusion criteria (8 listed)
- Menopausal women 50 years of age or older with no menstruation for at least 12 months.
- Self-reported vaginal atrophy symptoms and presence of all 4 common vaginal atrophy symptoms i.e., feeling of vaginal dryness, itching, burning sensation and dyspareunia.
- Sexually active women.
- Vaginal atrophy clinically confirmed through physical examination of vagina and vaginal pH; pH ≥ 5 and VHI ≤ 15.
- Patient who qualifies for Ectoin® Vaginal Gel treatment according to the approved indication and in physician's opinion the participant will benefit from this treatment.
Key exclusion criteria (10 listed)
- Women reporting systemic post-menopausal symptoms (eg. hot flushes, sleep disturbances, slowed metabolism etc.) in addition to clinically confirmed vaginal atrophy.
- Women who had not performed a cervical cytology in the last year to rule out underlying critical condition.
- Vaginal infections (in past 8 weeks)
- Women taking systemic hormone replacement or pills within last 6 months.
- Patients with concomitant clinically important medical disease according to the investigator's opinion that might interfere with patient safety or evaluation of study results; that includes but not limited to endometrial hyperplasia or cancer; undiagnosed vaginal bleeding; liver or kidney disorder; thromboembolic disorders; cerebrovascular accident, stroke, or transient ischemic attack; myocardial infarction or ischemic heart disease; malignancy; endocrine disease or any clinically important abnormalities on (if any) screening physical examination, mammogram, electrocardiogram (ECG), or laboratory tests (indicative of any vaginal infection).
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 |
|---|---|---|
| Ectoin® Vaginal GelEctoin® Vaginal Gel is a clear, non-hormonal moisturizing gel containing only active ingredient Ectoin® for the relief of vaginal dryness/vaginal atrophy. Other excipients in the formulation include: Hydroxyethylcellulose (Gelling agent) Lactic acid (90 %) (pH stabiliser) DL-Sodium lactate (Buffer substance) Sodium benzoate (preservative) Propylene glycol (Humectant) | Device | – |
Primary outcome
Change in Vaginal Health Index (VHI) Score
Time frame: treatment 20 days + FU 3 to 5 days
Assessment of vaginal lumen condition by gynaecologist from baseline to end of study on 20th day of application and thereafter, follow-up assessment in 3-5 days from end of treatment. The VHI components are graded from 1-5; where 1 indicating worst possible and 5 indicating best possible conditions.
7 secondary outcomes
Change in vaginal pH
Time frame: 20+ (3-5) days FU
Change in severity of VA symptoms (vaginal irritation, itching, vaginal dryness, and dyspareunia)
Time frame: 20+ (3-5) days FU
Change in total score in Quality of Life evaluation parameters
Time frame: 20+ (3-5) days FU
Change in score of overall vaginal atrophy condition
Time frame: 20+ (3-5) days FU
Change in score of symptoms based rating on need for treatment
Time frame: 20+ (3-5) days FU
Overall tolerability assessments
Time frame: 20 days
Number of AEs and assessment of intensity, causality and seriousness of Adverse Events
Time frame: 20 days
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 27 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
Shatadal Sen, MSc. study chair
Project Manager (Medical Device Development)
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 Vaginal Atrophy, run by Bitop AG at 1 site in Germany.
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 8 inclusion and 10 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 27 Jul 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 Germany. 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?
Change in Vaginal Health Index (VHI) Score (time frame: treatment 20 days + FU 3 to 5 days). 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 27 Jul 2023.