Status:
COMPLETED
A Twelve Week Study to Investigate the Efficacy of Femarelle®, for the Treatment of Post Menopausal Vaginal Atrophy
Lead Sponsor:
Dr. Lila Nachtigall Rapid Medical Research, New York
Collaborating Sponsors:
Se-cure Pharmaceuticals Ltd.
Conditions:
Vulvo Vaginal Atrophy
Eligibility:
FEMALE
40-85 years
Phase:
NA
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 ...
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, dyspareu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01502527
Start Date
January 1 2011
End Date
March 1 2012
Last Update
March 20 2017
Active Locations (1)
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1
Rapid Medical Research of New York
New York, New York, United States, 10016