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

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.

Study Overview

• Status: Completed
• Conditions: Vulvo Vaginal Atrophy
• Intervention / Treatment: Dietary supplement: Femarelle

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Rapid Medical Research of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Healthy post menopausal women between the ages of 40-85+yrs who complain of vaginal dryness with at least three urogenital symptoms from the following: vaginal dryness, vaginal irritation, vaginal soreness, dysuria, dyspareunia, bleeding with coitus & one of these symptoms must be moderate to severe as determined by patient, Moderate: discomforting and aware of it with activities. Severe: discomforting enough to interfere with activities Activities include sitting, walking, running, urinating, as well as sexual activity

• BMI 18-34 (inclusive).
• Patients having a LMP at least one year ago, either natural or surgical.
• Patients with a normal mammogram within 9 months prior to enrollment.
• Patients able to adhere to the visit schedule and protocol requirements and be available to complete the study.
• Patients who provide written informed consent to participate in the study.
• FSH > 40 mIU/m.
• Estradiol < 20 pg/ml.
• Vaginal PH > 5.
• < 5% superficial cells as assessed by vaginal cytology.
• Normal pelvic and breast exams by investigator.

Exclusion Criteria:

Patients using HRT (cannot have used for past 3 months).

• Patients consuming over the last three months high soy diet or any foods or other compounds that are sold as remedies for the post menopausal symptoms.
• Any history of significant cancer or pre-cancer, neurological, renal, cardiovascular, respiratory (e.g. asthma, COPD), hypercoagulability, hematopoietic disease, immune deficiency or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
• Patients with any clinically significant abnormality upon examination at screening visit.
• Patients with a known history of drug or alcohol abuse.
• Known hypersensitivity and/or allergy to soy or flax.
• Participation in another clinical trial within the past 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with Femarelle; An open labeled , twice daily treatment with Femarelle	Dietary supplement: Femarelle; Twice daily oral treatment with Femarelle; Other Names: DT56a

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement in VVA symptoms	Subjective and objective measures of VVA	12 weeks

Collaborators and Investigators

• Sponsor: Dr. Lila Nachtigall Rapid Medical Research, New York
• Collaborators: Se-cure Pharmaceuticals Ltd.
• Investigators: Principal Investigator: Lila Nachtigall, MD, Rapid Medical Research of New York

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: December 29, 2011
• First Submitted That Met QC Criteria: December 29, 2011
• First Posted (Estimate): December 30, 2011

Study Record Updates

• Last Update Posted (Actual): March 20, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Vulvo vaginal atrophy; Femarelle
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: SCS - 001