Clinical trial NCT01502527: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vulvo Vaginal Atrophy
Keywords: Vulvo vaginal atrophy
Femarelle
Lead sponsor: Dr. Lila Nachtigall Rapid Medical Research, New York
Sponsor class: OTHER
Collaborators: name: Se-cure Pharmaceuticals Ltd.
First posted: 2011-12-30
Enrollment: 12
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: improvement in VVA symptoms
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Rapid Medical Research of New York
state: New York
Study officials:
affiliation: Rapid Medical Research of New York
name: Lila Nachtigall, MD
role: PRINCIPAL_INVESTIGATOR
References: