A clinical study of a gel to be applied locally for adult female whose periods have stopped and who are having thinning, drying, swelling, pain and redness in the vagina.

Not Applicable

Completed

• Conditions: Health Condition 1: N768- Other specified inflammation of vagina and vulva

• Registration Number: CTRI/2019/05/019113
• Lead Sponsor: GIELLEPI SpA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-09-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1.Patient should be able to give written informed consent.

2. Subjects should be postmenopausal women for atleast 2 years (age between 50 â?? 65 years)

3. Postmenopausal women with vulvovaginal atrophy

4. Subject should have at least one self-assessed symptom of vulvar and vaginal atrophy (VVA):

a. Vaginal dryness

b. Vaginal and/or vulvar irritation/itching

c. Vaginal pain associated with sexual activity

d. Vaginal bleeding associated with sexual activity

5.Vaginal Health index (VHI) score during screening should be less than 15.

6. Subject with no significant illness other than vulvovaginal atrophy as judged by the Investigator

7. Ability to comply with requirements of trial.

Exclusion Criteria

1.Symptomatic Vaginal infection (urogenital infections including bacterial vaginosis, aerobic vaginitis, vulvovaginal candidiasis and trichomonas) requiring treatment

2. Genital bleeding of unknown cause

3. History of significant risk factors for endometrial cancer and breast cancer.

4. Known history of drug or alcohol abuse

5. Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.

6. 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.

7. Subjects on Hormone replacement therapy or chemotherapy or radiotherapy.

8. Subjects participating in any other studies.

9. 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.

10. 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.Change in objective symptoms assessed by Vaginal Health index <br/ ><br>2.Change in subjective symptom <br/ ><br>â?ª Vaginal dryness <br/ ><br>â?ª Vaginal Itching <br/ ><br>â?ª Vaginal Bleeding <br/ ><br>â?ª Burning Sensation <br/ ><br>3.Change in VAS scoring for Vaginal pain and Vaginal Dyspareunia <br/ ><br>4.Overall treatment satisfaction questionnaire and tolerability <br/ ><br>5.Improvement of sexual activity using <br/ ><br>FSFI questionnaire score.Timepoint: Screening, Week 2, 4 and 12

Secondary Outcome Measures

Name	Time	Method
1.Physical Examination <br/ ><br>2.Any reports of adverse or serious adverse events during the treatment period. <br/ ><br>3.Significant change in laboratory parameters <br/ ><br>4.Any abnormal vital signs.Timepoint: Screening, Week 2, 4 and 12