Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

Summary

This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.

Timeline

Start

2011-03

Primary completion

2014-07

Completion

2014-07

Outcome

Missed primary endpoint

Stopped (Enrollment): “Recruitment problems”

paper difference in favor of clobetasol 1.61; 95% CI 0.44 to 2.77, p = 0.009 PMID 35290878 ↗

paper Topical progesterone 8% ointment is inferior to standard therapy with topical clobetasol propionate 0.05% PMID 35290878 ↗

Publications

• Results Gunthert AR, Limacher A, Beltraminelli H, Krause E, Mueller MD, Trelle S, Bobos P, Juni P. Efficacy of topical progesterone versus topical clobetasol propionate in patients with vulvar Lichen sclerosus - A double-blind randomized phase II pilot study. Eur J Obstet Gynecol Reprod Biol. 2022 May;272:88-95. doi: 10.1016/j.ejogrb.2022.03.020. Epub 2022 Mar 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Progesterone	Other / unclassified	8 %	Topical
Subject	Progesterone	Other / unclassified	2 g	Topical
Comparator	clobetasol propionate	Small molecule	0.05 %	Topical
Comparator	clobetasol propionate	Small molecule	2 g	Topical

Indications