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NCT04910906: EIC01-PMCF
Non-Interventional Multicentre Post-market Study of Ectoin® Vaginal Gel for Symptomatic Treatment of Vaginal Atrophy
trial testing Ectoin® Vaginal Gel in Vaginal Atrophy in 155 participants. Completed in 9 February 2022.
9 February 2022
Quick facts
| Lead sponsor | Bitop AG |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 155 |
| Start date | 3 May 2021 |
| Primary completion | 9 February 2022 |
| Estimated completion | 9 February 2022 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Ectoin® Vaginal Gel
Conditions studied
- Vaginal Atrophy — all drugs for Vaginal Atrophy →
Sponsor
Bitop AG — full company profile →
Who can join
50 and older, female only, with Vaginal Atrophy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04910906
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Vaginal Atrophy
Currently open trials in the same condition.
- NCT05457972 — Postpartum Vaginal Estrogen for Breastfeeding Patients · Phase 4 · recruiting
- NCT06028009 — PRP Injections for Genitourinary Syndrome of Menopause · NA · active not recruiting
- NCT07024667 — Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vagin · NA · recruiting
- NCT05335317 — Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser · NA · recruiting
- NCT04807894 — Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo · Phase 4 · recruiting
Other Bitop AG trials
Trials by the same sponsor.
- NCT05699941 — Multicentre Post-market Study of Ectoin® Inhalation Solution in Treatment of Asthma. · NA · completed
- NCT04203810 — Effectiveness and Tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09) · NA · completed
- NCT04097327 — Effect of Ectoin Dermatitis Cream 7% on Skin Hydration and Skin Barrier Function · completed
- NCT03975257 — Ectoin Lozenges (EHT02) in the Treatment of Oropharyngeal Allergic Symptoms · NA · completed
- NCT04021225 — Comparison of Ectoin® Containing Eye Drops and Ectoin® Containing Eye Spray With the Eye Spray Tears Again® · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04910906 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bitop AG
- Last refreshed: 27 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04910906.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing