NCT03556800

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.

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.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Viramal Limited · Industry
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Accepted

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

• Menopause

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-05-22
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2018-06-14
• Last updated: 2022-04-27

Locations

1 site across 1 country: United Kingdom