Clinical study on Vimosa Softgel in vaginal dryness and vaginal prolapse

Phase 2

• Conditions: Health Condition 1: N814- Uterovaginal prolapse, unspecified

• Registration Number: CTRI/2024/05/067423
• Lead Sponsor: Abhinav Health Care Products Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified