Non-Interventional Multicentre Post-market Study of Ectoin® Vaginal Gel for Symptomatic Treatment of Vaginal Atrophy

NCT04910906 | Completed DMC

• 1 other identifier: btph-045-2020-EIC01
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Vaginal Atrophy

Keywords

vaginal atrophy; vaginal dryness; post-menopausal symptoms; post-menopausal Vaginal health

Outcome Measures

Primary Outcomes (1)

• 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.

  treatment 20 days + FU 3 to 5 days

Secondary Outcomes (7)

• Change in vaginal pH

  20+ (3-5) days FU

• Change in severity of VA symptoms (vaginal irritation, itching, vaginal dryness, and dyspareunia)

  20+ (3-5) days FU

• Change in total score in Quality of Life evaluation parameters

  20+ (3-5) days FU

• Change in score of overall vaginal atrophy condition

  20+ (3-5) days FU

• Change in score of symptoms based rating on need for treatment

  20+ (3-5) days FU

Interventions

Ectoin® Vaginal Gel DEVICE

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)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (1)

bitop AG

Dortmund, North Rhine-Westphalia, 44263, Germany

Location

Study Officials

• Shatadal Sen, MSc.

  Project Manager (Medical Device Development)

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 2, 2021
• Study Start: May 3, 2021
• Primary Completion: February 9, 2022
• Study Completion: February 9, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

DE (1)