Atrophic VaginitisPhase 1/2NCT02313545
Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment of AV and DIV
A Phase 1/2 study testing IZN-6NVS Cream in people with Atrophic Vaginitis, run by Izun Pharma Ltd at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Atrophic Vaginitis
- What is being tested?
- IZN-6NVS Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2014to Mar 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over age 18
- For groups 1 and 2:
- Self-reported amenorrhea for at least 12 months or documentation of menopause based on serum E2 ≤ 150 pg/ml.
- 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
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- Vaginal itching
- Vaginal pain associated with sexual activity
- Vaginal discharge
- Vaginal Malodor III. Clinical impression of atrophy based on examination of vaginal cytological smear.
- Vaginal pH >4.5
- 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:
- Willing to comply with use of an intravaginal cream containing S. nigra, C. asiatica, and E. purpurea extracts.
- Normal PAP smear within the last 3 years. III. Able to provide informed consent. -
Who cannot join
- 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
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- 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.
- -
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Seattle Women's
Seattle, Washington, 98105
Eastchester Medical Associates
The Bronx, New York, 10469
About this study
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
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).
Read the 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.
- Conditions
- Atrophic Vaginitis
- Being tested
- IZN-6NVS Cream
- Medical subject headings
- Atrophic Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IZN-6NVS CreamDrug
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%
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: IZN-6NVS Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Day 0, Day 14, Day 42
Change in vaginal pH
At each time pion mentioned above, Vaginal pH will be determined
Measured: 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.
Measured: Day 0, Day 14, Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izun Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabe Nussbaum, MD, PhD, Study director, Izun Pharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313545
- Sponsor's protocol ID
- IAV-MAE-101-IL
- Status last verified
- Mar 2018
- First submitted
- 7 Dec 2014
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02313545
- Acronym / sponsor ID
- IAV-MAE-101-IL
- Conditions
- Atrophic Vaginitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Izun Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 10 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental - IZN-6NVS Cream | Experimental | Drug: IZN-6NVS CreamEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Women over age 18
- For groups 1 and 2:
- For group 3 (DIV): Clinical diagnosis of DIV in pre-menopausal women without estrogen deficiency.
- For all groups:
- Willing to comply with use of an intravaginal cream containing S. nigra, C. asiatica, and E. purpurea extracts.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IZN-6NVS CreamIZN-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% | Drug | Experimental - IZN-6NVS Cream |
Primary outcome
Safety basis of the following parameters: - General Toxicity: Vital signs (temperature, blood pressure, pulse rate, respiratory rate). - Adverse events and toxicity
Time frame: 6 weeks
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
Time frame: Day 0, Day 14, Day 42, Day 84
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)
Time frame: Day 0, Day 14, Day 42
At each time pion mentioned above, Cells will be collected to determine the vaginal maturation index.
Change in vaginal pH
Time frame: Day 0, Day 14, Day 42
At each time pion mentioned above, Vaginal pH will be determined
Change in pro-inflammatory cytokine levels in vaginal secretions
Time frame: Day 0, Day 14, Day 42
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabe Nussbaum, MD, PhD study director
Izun Pharma Ltd
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IZN-6NVS Cream in people with Atrophic Vaginitis, run by Izun Pharma Ltd at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety basis of the following parameters: - General Toxicity: Vital signs (temperature, blood pressure, pulse rate, respiratory rate). - Adverse events and toxicity (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.