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

NCT ID: NCT01502527

Last Updated: 2017-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-03-31

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.

Conditions

Vulvo Vaginal Atrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with Femarelle

An open labeled , twice daily treatment with Femarelle

Group Type: EXPERIMENTAL

Femarelle

Intervention Type: DIETARY_SUPPLEMENT

Twice daily oral treatment with Femarelle

Interventions

Femarelle

Twice daily oral treatment with Femarelle

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

DT56a

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Se-cure Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: collaborator

Dr. Lila Nachtigall Rapid Medical Research, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lila Nachtigall, MD

Role: PRINCIPAL_INVESTIGATOR

Rapid Medical Research of New York

Locations

Rapid Medical Research of New York

New York, New York, United States

Countries

United States

Other Identifiers

SCS - 001

Identifier Type: -

Identifier Source: org_study_id