Back to results

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

Primary Purpose

Atrophic Vaginitis

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

IZN-6NVS Cream

About this trial

This is an interventional treatment trial for Atrophic Vaginitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.
-

Sites / Locations

Eastchester Medical Associates
Seattle Women's
Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental - IZN-6NVS Cream

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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.

Change in VMI (Vaginal Maturation Index)

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

Change in vaginal pH

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02313545

First Posted

December 7, 2014

Last Updated

March 12, 2018

Sponsor

Izun Pharma Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02313545

Brief Title

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

Official Title

Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment of Atrophic Vaginitis or Desquamative Inflammatory Vaginitis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

December 2014 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Izun Pharma Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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 estrogen. Group 2: Women rendered menopausal as a result of pharmacologic treatment (including, but not limited to, aromatase inhibitor treatment, selective estrogen receptor modifiers (SERMs), and GnRH analog treatment), who decline treatment with topical or systemic estrogen. Group 3: Pre-menopausal women diagnosed with DIV. 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). 20 eligible women of groups 1 and 2 and up to 10 eligible women of group 3 will be assigned to receive 2.5 g of cream/day for the first 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, which will be the end of the study. Patient reported symptom severity will be assessed by questionnaire at baseline and after 2 and 6 weeks of treatment, and at follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrophic Vaginitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental - IZN-6NVS Cream

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

IZN-6NVS Cream

Intervention Description

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%

Primary Outcome Measure Information:

Title

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

Description

Time Frame

6 weeks

Title

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

Description

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

Time Frame

Day 0, Day 14, Day 42, Day 84

Title

Change in VMI (Vaginal Maturation Index)

Description

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

Time Frame

Day 0, Day 14, Day 42

Title

Change in vaginal pH

Description

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

Time Frame

Day 0, Day 14, Day 42

Title

Change in pro-inflammatory cytokine levels in vaginal secretions

Description

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.

Time Frame

Day 0, Day 14, Day 42

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gabe Nussbaum, MD, PhD

Organizational Affiliation

Izun Pharma Ltd

Official's Role

Study Director

Facility Information:

Facility Name

Eastchester Medical Associates

City

Bronx

State/Province

New York

ZIP/Postal Code

10469

Country

United States

Facility Name

Seattle Women's

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Shaare Zedek Medical Center

City

Jerusalem

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs