Back to resultsA Twelve Week Study to Investigate the Efficacy of Femarelle®, for the Treatment of Post Menopausal Vaginal Atrophy
Primary Purpose
Vulvo Vaginal Atrophy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Femarelle
Sponsored by
About this trial
This is an interventional treatment trial for Vulvo Vaginal Atrophy focused on measuring Vulvo vaginal atrophy, Femarelle
Eligibility Criteria
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.
Sites / Locations
- Rapid Medical Research of New York
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with Femarelle
Arm Description
An open labeled , twice daily treatment with Femarelle
Outcomes
Primary Outcome Measures
improvement in VVA symptoms
Subjective and objective measures of VVA
Secondary Outcome Measures
Full Information
NCT ID
NCT01502527
First Posted
December 29, 2011
Last Updated
March 16, 2017
Sponsor
Dr. Lila Nachtigall Rapid Medical Research, New York
Collaborators
Se-cure Pharmaceuticals Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01502527
Brief Title
A Twelve Week Study to Investigate the Efficacy of Femarelle®, for the Treatment of Post Menopausal Vaginal Atrophy
Official Title
An Open Labeled Prospective Study to Investigate the Effect of Femarelle® on Vulvo-vaginal Atrophy Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Lila Nachtigall Rapid Medical Research, New York
Collaborators
Se-cure Pharmaceuticals Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvo Vaginal Atrophy
Keywords
Vulvo vaginal atrophy, Femarelle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Femarelle
Arm Type
Experimental
Arm Description
An open labeled , twice daily treatment with Femarelle
Intervention Type
Dietary Supplement
Intervention Name(s)
Femarelle
Other Intervention Name(s)
DT56a
Intervention Description
Twice daily oral treatment with Femarelle
Primary Outcome Measure Information:
Title
improvement in VVA symptoms
Description
Subjective and objective measures of VVA
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lila Nachtigall, MD
Organizational Affiliation
Rapid Medical Research of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rapid Medical Research of New York
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Twelve Week Study to Investigate the Efficacy of Femarelle®, for the Treatment of Post Menopausal Vaginal Atrophy
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