A study of evaluate the efficacy and safety of investigational product Femildo(TM) in management of sexual dysfunction in wome
- Registration Number
- CTRI/2019/01/016868
- Lead Sponsor
- ADSO Naturals Holdings BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 24
1.Female volunteer with age range 20-50 yrs. actively living with a partner at least 15 days per month, being in child bearing age, lack and or loss of libido which causes distress.
2. BMI of 18-29 kg/m2
3. A face to face interview based on Diagnostic and Statistical Manual Dental Disorders (DSM-IV-TR) codes for HSDD.
4. Willing to give inform consent abiding with trial procedures and come for the follow up visits.
• Pregnant, lactating women and menopause
• Subjects with any serious illness and undergone any kind of surgery (e.g. tubectomy, hysterectomy etc.) within past 6 months
• History of genital tract or breast cancers
• Suffering from major depression disorder or other psychiatric disorders and active plan for divorce.
• Significant central nervous system diseases within the last 6 months, i.e., stroke, spinal cord injury, multiple sclerosis, etc.
• Subjects with hypotension or uncontrolled hypertension, uncontrolled diabetes, hepatic impairment, renal impairment or hematological disorders
• Subjects should not have participated in any other clinical trials during the last 3 months prior to the beginning of this study
• Inability to take or consume investigational product
• History of substance misuse.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the change in Female Sexual Function Index scores at baseline (Day 1), Day 30 and end of visit (Day 90) between treatment groups.Timepoint: Baseline Visit(Day 1), Day 30 and End of visit (Day 90)
- Secondary Outcome Measures
Name Time Method Monitoring of Adverse EventTimepoint: Baseline Visit(Day 1), Day 30, Day 60 and End of visit (Day 90)