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Study to Investigate the Pharmacokinetics & Safety Following One Application of 3 Different Doses 0.5,0.75,& 1.25 gm,a Transdermal Estradiol Cream (VML-0203), in Comparison to a Single Dose of EstroGel 1.25 gm to Healthy Post-menopausal Women.

NCT03556800 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-04-27

No results posted yet for this study

Summary

This study is a Phase I, Randomized, Open-Label, Single Center, Cross-over Study to Investigate the Pharmacokinetics and Safety following a Single Application of Three Different Doses 0.5 gm (0.5 mg estradiol), 0.75 gm (0.75 mg estradiol) and 1.25 gm (1.25 mg estradiol), a Transdermal Estradiol Cream (VML-0203), in comparison to a single dose of EstroGelTM 1.25 gm (1 unit/0.75 mg of estradiol) to healthy post-menopausal women.

Conditions

Interventions

DRUG

Estrogel

Each subject will receive the following IMPs in accordance with the randomisation code: * Test IMP: a single-dose of 0.5g, 0.75g and 1.25g VML-0203 cream * Reference IMP: a single-dose of 1.25g EstroGel

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Viramal Limited

    lead INDUSTRY

Principal Investigators

  • Dr Simona Fiore, MD · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-22
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03556800 on ClinicalTrials.gov