NCT01502527

A Twelve Week Study to Investigate the Efficacy of Femarelle®, for the Treatment of Post Menopausal Vaginal Atrophy

An Open Labeled Prospective Study to Investigate the Effect of Femarelle® on Vulvo-vaginal Atrophy Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Dr. Lila Nachtigall Rapid Medical Research, New York · Academic / Other
• Sex: Female
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Based on previous data published on the SERM properties of Femarelle, the investigators hypothesized that Femarelle could be a potential treatment for Vulvo-vaginal atrophy(VVA) symptoms. The current study was a pilot study to examine the effect of Femarelle® on VVA symptoms in symptomatic post-menopausal women.

Detailed description

Post-menopausal women aged 54-77, with vaginal atrophy (\< 5% superficial cells on cervical cytology) with at least one moderate-to-severe VVA symptom (dryness, irritation, soreness, dysuria, dyspareunia, or bleeding with coitus), will be recruited for a 12-week open-label pilot study. The study protocol was approved by Schulman Associates IRB.Femarelle will be given twice daily and subjective symptoms as well as objective measures like inspection and vaginal pH will be measured.

Conditions

• Vulvo Vaginal Atrophy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Femarelle	Twice daily oral treatment with Femarelle

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-12-30
• Last updated: 2017-03-20

Locations

1 site across 1 country: United States