Status:
COMPLETED
Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment of AV and DIV
Lead Sponsor:
Izun Pharma Ltd
Conditions:
Atrophic Vaginitis
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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 week...
Detailed Description
This will be a Phase IB study comprised of three study groups: * Group 1: Women who are naturally or surgically menopausal and symptomatic for AV, but who decline treatment with topical or systemic e...
Eligibility Criteria
Inclusion
- 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. -
Exclusion
- 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.
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Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02313545
Start Date
December 1 2014
End Date
March 1 2017
Last Update
March 14 2018
Active Locations (3)
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1
Eastchester Medical Associates
The Bronx, New York, United States, 10469
2
Seattle Women's
Seattle, Washington, United States, 98105
3
Shaare Zedek Medical Center
Jerusalem, Israel