The trial assesses the efficacy and safety of a vaginalgel for dryness

Efficacy and Safety of a hyaluronic and lactic acid containing vaginal gel “HydroSanta® Vaginalgel” for the treatment of vaginal dryness symptoms – a multicenter randomized two-arm study

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001801-56-AT

Enrollment

Registered

2021-08-30

Start date

2021-09-29

Completion date

Unknown

Last updated

2021-10-18

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

Conditions

MedDRA version: 21.1 Level: LLT Classification code 10047782 Term: Vulvovaginal atrophy System Organ Class: 100000004872

Interventions

Trade Name: Estrokad 0.03 Vaginalzäpfchen Product Name: Estrokad 0.03mg Vaginalzäpfchen Pharmaceutical Form: Suppository INN or Proposed INN: ESTRIOL CAS Number: 50-27-1 Concentration unit: mg milligr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Informed consent • Biological sex: female (women only) • Women with moderate or severe vaginal dryness • Age > 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Pregnancy • Currently under vaginal atrophy treatment • Vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV) • Patients with breast cancer, uterine cancer or estrogen hormone-dependent tumors, and genital bleeding of unknown origin • Known allergy against ingredients of the study intervention (e.g. estriol)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of the investigational medical device on vaginal dryness symptoms in adult subjects To assess the safety of the investigational medical device in adult subjects ;Secondary Objective: To assess user’s experience with the product under investigation (usability, customer satisfaction, package information leaflet / instruction for use);Primary end point(s): Efficacy: Improvement in vaginal dryness estimated with the VAS Safety: Amount of adverse events occurred since baseline estimated via reports and interviews Amount of serious adverse events occurred since baseline estimated via reports and interviews ;Timepoint(s) of evaluation of this end point: Week 3	—

Measure

Time frame

Main Objective: To assess the efficacy of the investigational medical device on vaginal dryness symptoms in adult subjects To assess the safety of the investigational medical device in adult subjects ;Secondary Objective: To assess user’s experience with the product under investigation (usability, customer satisfaction, package information leaflet / instruction for use);Primary end point(s): Efficacy: Improvement in vaginal dryness estimated with the VAS Safety: Amount of adverse events occurred since baseline estimated via reports and interviews Amount of serious adverse events occurred since baseline estimated via reports and interviews ;Timepoint(s) of evaluation of this end point: Week 3

—

Secondary

Measure	Time frame
Secondary end point(s): Efficacy: Improvement in vaginal dryness estimated with the VAS Improvement in vaginal burning estimated with the VAS Improvement in vaginal itching estimated with the VAS Satisfaction with the treatment method estimated with a questionnaire ;Timepoint(s) of evaluation of this end point: Week 3 and week 12	—

Countries

Austria

Contacts

Public ContactProject Management

Mag. Andreas Raffeiner GmbH

submission@studien-monitor.at00436763415342

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026