A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy

Summary

This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

Timeline

Start

2004-11

Primary completion

2006-02

Completion

2006-02

Outcome

Met primary endpoint

paper Synthetic conjugated estrogens B yielded statistically significantly greater differences in vaginal maturation index and vaginal pH from baseline to the end of treatment. PMID 18053998 ↗

paper A statistically significant mean reduction in the severity of the MBS was noted for SCE-B. PMID 18053998 ↗

Publications

• Simon JA, Reape KZ, Wininger S, Hait H. Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women. Fertil Steril. 2008 Oct;90(4):1132-8. doi: 10.1016/j.fertnstert.2007.07.1359. Epub 2007 Dec 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Synthetic Conjugated estrogens, B	Unknown	0.3 mg	Oral

Indications

No indication recorded.