Study on a vulvo-vaginal gel
- Conditions
- Health Condition 1: N762- Acute vulvitis
- Registration Number
- CTRI/2021/07/034644
- Lead Sponsor
- GIELLEPI SpA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1. Patient should be able to give written informed consent.
2. Adult women (18-45years old).
3. Patients diagnosed with vulvar vestibulitis if they meet the following
criteria:
a. history of vulvar pain with tampon insertion or attempted
intromission,
b. focal areas of erythema confined to the vulvar vestibule,
c. tenderness upon palpation of these areas with a cotton tipped
applicator (ââ?¬Å?Friedrichââ?¬•s Criteriaââ?¬?),
d. exclusion of other causes for these findings,
e. symptoms present for 3 months or more.
4. Patients with coexisting vulvovaginal candidiasis, on maintenance
with azole and negative follow up fungal cultures, yet still fulfilled
the criteria for vulvar vestibulitis.
5. Patients not taking any other therapy for vulvar vestibulitis for at least
a month before enrolment.
6. Ability to comply with requirements of trial
1. Pregnant and lactating women.
2. Subjects with clinically significant history of co-morbid condition
and other specific neuropathology, atrophic vaginitis, dermatitis such
as vulvar dystrophy, or pathogens such as culture/smear-proven
Candida spp. or Herpes simplex.
3. Subjects on hormone replacement therapy or chemotherapy or
radiotherapy.
4. Subjects participating in any other clinical studies or participated in
any clinical trial 3 months prior to start of this trial.
5. Genital bleeding of unknown cause.
6. Known history of malignancy.
7. Known history of drug or alcohol abuse.
8. Subjects who, in the opinion of the investigator, are mentally
incapacitated such that informed consent cannot be obtained.
9. Subjects with clinically significant history of co-morbid condition (like, diabetes, immunodeficiency, HIV, HPV) that in the opinion of
the investigator could affect the efficacy and safety outcome of the
study.
10. Presence of disease states that could affect safety and efficacy
evaluation, such as hepatic (e.g., cirrhosis with Child-Pugh Class B or
C or MELD score > 9), renal (e.g., requiring dialysis), gastrointestinal
(e.g., acute or chronic diverticulitis, irritable bowel syndrome with
epigastric pain as a predominant symptom or active inflammatory
bowel disease), dermatological, hematologic, neurologic or brain
disorders (e.g., strokes, and brain injury), psychiatric (e.g., bipolar
disorder, severe active depression, severe active anxiety), or any other
significant condition which, in the opinion of the Investigator, could
confound or interfere with evaluation of efficacy, safety, or tolerability
of the investigational drug, or prevent compliance with the study
protocol.
11. Known hypersensitivity to, or intolerance of, study products or their
formulation excipients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Reduction of; <br/ ><br>a. Dyspareunia <br/ ><br>b. Burning sensation <br/ ><br>c. Itching <br/ ><br>d. Erythema <br/ ><br>e.Swab test assessed by, <br/ ><br>Cotton <br/ ><br>Vulvar Pain Assessed by, <br/ ><br>Cotton swab <br/ ><br>Scoring will be according to 10cm VAS. <br/ ><br>2.Reduction in Marinoff Dyspareunia Grade <br/ ><br>3.Improvement of FSFI <br/ ><br>4.Change in FSDS <br/ ><br>5.Improvement in HRQL SF-36 <br/ ><br>6.Overall treatment satisfaction <br/ ><br>7.Improvement of ADHS <br/ ><br>8.Overall assessment of tolerability <br/ ><br>Timepoint: Screening, Week 1, 2 and 4.
- Secondary Outcome Measures
Name Time Method 1.Physical Examination <br/ ><br>2.Vital Signs: Pulse rate, blood pressure and body temperature <br/ ><br>3.Lab assessment (Hematology, Biochemistry- SGOT, SGPT,and Serum Creatinine) (needed for safety evaluation <br/ ><br>4. Adverse Event Assessments <br/ ><br>5. pH Quantitative test <br/ ><br>6. Saline and 10% KOH microscopyTimepoint: Screening and 4.