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Investigation of 3 different doses of a newly developed vaginal ring releasing estriol for the treatment of vaginal atrophy - a placebo-controlled, double-blind, combined dose-finding and proof-of-concept trial with parallel-group design in postmenopausal women

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514302-31-00
Acronym
1452est24ct
Enrollment
112
Registered
2025-06-16
Start date
2025-07-16
Completion date
Unknown
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal atrophy

Brief summary

Change from baseline in vaginal Maturation Value (MV) after 90 days of treatment, Change from baseline in % of vaginal superficial cells after 90 days of treatment, Change from baseline in % of vaginal parabasal cells after 90 days of treatment, Change from baseline in vaginal pH after 90 days of treatment, Proportion of responders with a vaginal pH ≤ 5 after 90 days of treatment, Total (AUC) E3 exposure over the course of treatment

Interventions

DRUGVR 102 (10 µg/day)
DRUGPlacebo vaginal ring without active drug
DRUGVR 102 (1 µg/day)
DRUGVR 102 (20 µg/day)

Sponsors

SocraTec R&D Concepts in Drug Research and Development GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in vaginal Maturation Value (MV) after 90 days of treatment, Change from baseline in % of vaginal superficial cells after 90 days of treatment, Change from baseline in % of vaginal parabasal cells after 90 days of treatment, Change from baseline in vaginal pH after 90 days of treatment, Proportion of responders with a vaginal pH ≤ 5 after 90 days of treatment, Total (AUC) E3 exposure over the course of treatment—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026