Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment of AV and DIV

Completed · Phase 1/Phase 2

Conditions studied: Atrophic Vaginitis

In brief

In this open label study, 50 eligible women will be assigned to receive the investigational product (IZN-6NVS) - 2.5 g of cream/day for 14 days, followed by 3 applications per week for the next 4 weeks. Clinical assessment of the severity of vaginitis will be performed at baseline and after 2 and 6 weeks of treatment. The study will evaluate safety, tolerability and efficacy of IZN-6NVS vaginal cream, in the treatment of atrophic vaginitis (AV) and desquamative inflammatory vaginitis (DIV).

Key facts

Study ID

NCT02313545

Run by

Izun Pharma Ltd

People needed

50

Starts

2014-12-01

Expected to finish

2017-03-01

Last updated by the study team

2018-03-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women over age 18
• For groups 1 and 2:
• I. Self-reported amenorrhea for at least 12 months or documentation of menopause based on serum E2 ≤ 150 pg/ml.
• II. Self-reporting of at least one moderate to severe symptom of vaginal atrophy on a 4-point scale (0=none; 1=mild; 2=moderate; 3=severe):
• Vaginal dryness
• Vaginal discomfort or irritation
• Vaginal itching
• Vaginal pain associated with sexual activity
• Vaginal discharge
• Vaginal Malodor III. Clinical impression of atrophy based on examination of vaginal cytological smear.
• IV. Vaginal pH >4.5
• V. Endometrial thickness ≤5 mm as determined by US, with no abnormalities noted.
• For group 3 (DIV): Clinical diagnosis of DIV in pre-menopausal women without estrogen deficiency.
• For all groups:
• I. Willing to comply with use of an intravaginal cream containing S. nigra, C. asiatica, and E. purpurea extracts.
• II. Normal PAP smear within the last 3 years. III. Able to provide informed consent. -

You may not qualify if…

• Subjects recruited in group 1 should not be actively treated for breast, uterine or ovarian cancer within the past year.
• Vaginal bleeding of unknown cause within 60 days of enrollment
• Vaginal infection requiring treatment within 30 days of enrollment
• Any known allergy to the plant extracts in the study cream
• Any serious disease; concomitant steroid use or sex hormone treatment
• Endometrial thickness > 5 mm measured by ultrasound for women enrolled with diagnosis of atrophic vaginitis
• Use of any vaginal moisturizer (e.g. Replens, Gynomonal) within 30 days of enrollment.
• In groups 1 and 2, Use of any oral, transdermal, vaginal, or systemic estrogen or estrogen/progestin product within 30 days of enrollment.
• Current urinary tract infection (UTI) (clinical complaints of UTI or dipstick urinalysis positive for nitrates or blood)
• History of venous thromboembolic disease.
• Use of another investigational agent within 12 weeks of screening.
• Any medical or psychiatric condition that, in the investigator's opinion, would preclude the subject from complying with the study protocol, including the completion of questionnaires.
• Subjects with DIV who are pregnant or trying to become pregnant will not be included in the study. Similarly, if a subject with DIV becomes pregnant during the study, that patient will be removed from the study.

Where it is running

• Eastchester Medical Associates — The Bronx, New York, United States
• Seattle Women's — Seattle, Washington, United States
• Shaare Zedek Medical Center — Jerusalem, Israel

Full record on ClinicalTrials.gov

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