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

NCT01502527 | Completed

• 1 other identifier: SCS - 001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvo Vaginal Atrophy

Keywords

Vulvo vaginal atrophy; Femarelle

Outcome Measures

Primary Outcomes (1)

• improvement in VVA symptoms

  Subjective and objective measures of VVA

  12 weeks

Study Arms (1)

Treatment with Femarelle

EXPERIMENTAL

An open labeled , twice daily treatment with Femarelle

Dietary Supplement: Femarelle

Interventions

Femarelle DIETARY_SUPPLEMENT

Twice daily oral treatment with Femarelle

Also known as: DT56a

Treatment with Femarelle

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Lila Nachtigall Rapid Medical Research, New York: lead
• Se-cure Pharmaceuticals Ltd.: collaborator

Study Sites (1)

Rapid Medical Research of New York

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

DT56a

Study Officials

• Lila Nachtigall, MD

  Rapid Medical Research of New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: December 30, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 20, 2017

Record last verified: 2017-03

Locations

US (1)