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

Completed · Not applicable

Conditions studied: Vulvo Vaginal Atrophy

In brief

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.

Key facts

Study ID

NCT01502527

Run by

Dr. Lila Nachtigall Rapid Medical Research, New York

People needed

12

Starts

2011-01-01

Expected to finish

2012-03-01

Last updated by the study team

2017-03-20

Who can join

Age: 40 and older, up to 85. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

• Rapid Medical Research of New York — New York, New York, United States

Full record on ClinicalTrials.gov

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