Health Condition 1: N814- Uterovaginal prolapse, unspecified
Conditions
Interventions
None listed
Sponsors
Abhinav Health Care Products Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Cohort 1 1. Female subjects (21 to 70 years) with symptoms of vaginal dryness due to various causes including reduced secretory function of the vaginal epithelium, anti-estrogen medications, hormonal therapy, use of scented or perfumed soaps, sprays and washes around or in vagina, removal of ovaries etc. 2. A negative urine pregnancy test for all female subjects unless patient has had a hysterectomy, tubal ligation, or is greater than 2 years post menopause. Cohort 2 1 Females (30 to 60 years) with first or second degree uterovaginal prolapse 2.A negative urine pregnancy test for all female patients unless patient has had a hysterectomy, tubal ligation, or is greater than 2 years post menopause.
Exclusion criteria
Exclusion criteria: Cohort 1: 1. Patients with vaginal infections such as trichomonas, candida & bacterial vaginosis (BV). 2. Subjects who are known cases of Diabetes having uncontrolled blood sugar levels (fasting blood sugar levels NMT 250 mg per dl and HbA1c NMT 8 percent) 3. Patients with breast cancer, uterine cancer and genital bleeding of unknown origin. 4. Patients using medications (internally and externally) that promote healing 5. History of Use of any other investigational product within 1 month prior to randomization 6. Known history of hypersensitivity to ingredients used in study product 7. Pregnant and breast-feeding women Cohort 2: 1. Patients with Procidentia, congenital elongation of cervix, cervical fibroid, polyp, chronic inversion of uterus. 2. Patients who have been advised to undergo surgical removal of uterus or surgical treatment for Utero-vaginal prolapse 3. Subjects who are known cases of Diabetes having uncontrolled blood sugar levels (fasting blood sugar levels NMT 250 mg per dl and HbA1c NMT 8 percent) 4. Patients with uterine cancer and genital bleeding of unknown origin. 5. Patients with known history of significant cardiovascular event 12 weeks prior to randomization. 6. History of Use of any other investigational product within 1 month prior to randomization 7. Known history of hypersensitivity to ingredients used in study product 8. Pregnant and breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1: Change in Vaginal dryness using VAS. Cohort 2: Change in mass per vaginum Timepoint: Cohort 1: Screening or Baseline visit (Day 0), Visit 1 (Day 15) and Visit 2 (Day 30) Cohort 2: Screening or Baseline visit (Day 0). Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1: 1. Change in itching, dyspareunia, burning, painful sex as assessed using VAS 2. Change in pH of vagina. 3. Change in quality of life as assessed using WHO QOL BREF 4. Assessment of requirement of rescue medications 5. Global assessment of overall change as assessed by investigator and subjects 6. Assessment of tolerability of the study product 7. Assessment of adverse events and vitals Cohort 2: 1. Changes in urinary incontinence, backache and lower abdominal discomfort 2. Change in Pelvic Floor Distress Inventory Questionnaire (PFDIQ-20) 3. Change in quality of life as assessed using WHO QOL BREF 4. Assessment of requirement of rescue medications 5. Change in global assessment for overall change by subject and investigator 6. Assessment of tolerability of the study product 7. Assessment of adverse events and vitals Timepoint: Cohort 1: Screening or Baseline visit (Day 0), Visit 1 (Day 15) and Visit 2 (Day 30) Cohort 2: Screening or Baseline visit (Day 0). Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd.
Outcome results
None listed