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

NCT02313545 | Completed Phase 1

• 1 other identifier: IAV-MAE-101-IL
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 3

Brief Summary

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).

Conditions

Atrophic Vaginitis

Outcome Measures

Primary Outcomes (5)

• Safety basis of the following parameters: - General Toxicity: Vital signs (temperature, blood pressure, pulse rate, respiratory rate). - Adverse events and toxicity

  Safety and tolerability will be evaluated on the basis of the following parameters: * General Toxicity: Vital signs (temperature, blood pressure, pulse rate, respiratory rate). * Adverse events and toxicity

  6 weeks

• Change in composite score of vaginal symptoms as assessed by subject questionnaire from baseline

  At each time pion mentioned above, subjects will complete a Vaginal Symptoms questionnaire, subject will complete the questionnaire on their own.

  Day 0, Day 14, Day 42, Day 84

• Change in VMI (Vaginal Maturation Index)

  At each time pion mentioned above, Cells will be collected to determine the vaginal maturation index.

  Day 0, Day 14, Day 42

• Change in vaginal pH

  At each time pion mentioned above, Vaginal pH will be determined

  Day 0, Day 14, Day 42

• Change in pro-inflammatory cytokine levels in vaginal secretions

  At each time pion mentioned above, vaginal secretions will be sampled by swab and samples will be frozen for determination of cytokine levels at a later time piont.

  Day 0, Day 14, Day 42

Study Arms (1)

Experimental - IZN-6NVS Cream

EXPERIMENTAL

Eligible women of 3 groups will be assigned to receive IZN-6NVS (IP) - 2.5 g of cream/day for the first 14 days, followed by 3 applications per week for the next 4 weeks.

Drug: IZN-6NVS Cream

Interventions

IZN-6NVS Cream DRUG

IZN-6NVS, a hydrocream containing three herbal extracts, is a polymolecular agent derived from botanical sources. It is composed of a blend of three herbal extracts, Centella asiatica, Echinacea purpurea, and Sambucus nigra. Cream concentration: 5%

Experimental - IZN-6NVS Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Izun Pharma Ltd: lead

Study Sites (3)

Eastchester Medical Associates

The Bronx, New York, 10469, United States

Location

Seattle Women's

Seattle, Washington, 98105, United States

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Atrophic Vaginitis

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Gabe Nussbaum, MD, PhD

  Izun Pharma Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2014
• First Posted: December 10, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

IL (1); US (2)