Clinical study to evaluate efficacy and safety of Vimosa softgel capsule in vaginal dryness and vaginal prolapse – An open label, single arm, multi-center, interventional, prospective, clinical study - NI

Abhinav Health Care Products Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•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.
•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.

•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
•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

发起方

Abhinav Health Care Products Pvt Ltd