Clinical trial: Famvir for Treatment of Hearing in Unilateral Meniere's Disease (NCT01526408)

Eligibility criteria:
Inclusion Criteria:

          -  Unilateral Meniere's Disease

          -  2 vertigo episodes of at least 20 minutes

          -  Fluctuating hearing by subjective history and/or audiometric documentation.
             Audiometric documentation is defined as affected ear pure-tone average change from an
             audiogram at Time 1 to Time 2 (less than one year apart) of greater than 15 dB.

          -  Less than 45 dB 4-frequency pure-tone average in the affected ear

          -  Tinnitus and/or aural fullness

          -  Willing to undergo the clinical trial procedures

          -  Signed informed consent

        Exclusion Criteria:

          -  Acute or chronic middle ear disease in either ear

          -  Only hearing ear

          -  4-frequency pure-tone average > 45 dB in either ear

          -  Known allergy to famciclovir or any of the ingredients in the formulation

          -  Taking oral steroids or receiving IT steroids at time of enrollment. If the subject
             has been on oral steroids/IT steroids, 3 months must elapse from last dose to start of
             treatment in the study

          -  Must not have had previous inner ear surgery

          -  History of immunodeficiency diseases such as HIV

          -  History of renal insufficiency or other kidney diseases

          -  A female of child-bearing potential who is pregnant

          -  History of noncompliance to medical regimens

          -  Unwilling to or unable to comply with the protocol, including scheduling study
             evaluations
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years

Patient description (medical language): A 47-year-old woman comes to the clinic complaining of dizziness.  She also has occasional nausea and ringing in her right ear.  The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal.  The dizziness improves spontaneously, and she feels fine between episodes.  Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl.  She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago.

Patient description (patient's own words): The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now.

Does the patient match the trial criteria? Entailment