Status:
COMPLETED
Non-Interventional Multicentre Post-market Study of Ectoin® Vaginal Gel for Symptomatic Treatment of Vaginal Atrophy
Lead Sponsor:
Bitop AG
Conditions:
Vaginal Atrophy
Eligibility:
FEMALE
50+ years
Brief 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 inve...
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 ISO14155:2...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
May 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 9 2022
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT04910906
Start Date
May 3 2021
End Date
February 9 2022
Last Update
July 27 2023
Active Locations (1)
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1
bitop AG
Dortmund, North Rhine-Westphalia, Germany, 44263