Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis

Inclusion Criteria

• Male or female ≥ 18 years of age with a diagnosis of moderate to severe IC;
• Bladder pain ≥ 6 months prior to baseline;
• Urinary frequency of ≥ 8 ≤ 30 micturitions within 24 hours while awake;
• Nocturia ≥ 2x/night;
• Males and females of child-bearing potential (not surgically sterile or post-menopausal) must be abstinent or agree to use an study-accepted contraceptive regimens throughout the study:
• Female patients of child bearing age must have a negative urine pregnancy test at screening;
• Must provide a signed informed consent.

Exclusion Criteria

• Male or females < 18 years of age;
• Initiation of new IC medication ≤ 30 days prior to baseline;
• Treatment with Elmiron ≤ 120 days prior to baseline;
• Treatment with bladder hydro-distention ≤ 6 months prior to baseline;
• Treatment with intravesical therapy ≤ 60 days prior to baseline;
• History of previous procedure(s) (e.g., augmentation cytoplasty, cystectomy or cystolysis) that has affected bladder function;
• Active genital herpes or vaginitis ≤ 90 days prior to baseline;
• Urinary tract or prostatic infection ≤ 90 days prior to baseline;
• History of urethral diverticulum;
• History of bladder or ureteral calculi;
• History of cyclophosphamide or chemical cystitis, urinary tuberculosis or radiation cystitis;
• History of bladder tumors;
• History of uterine, cervical, vaginal, prostatic or urethral cancer ≤ 5 years prior to baseline;
• Patient is currently pregnant, lactating or likely to become pregnant during the study;
• Participated in another clinical study with an investigational drug or device ≤ 30 days prior to baseline.