A study of evaluate the efficacy and safety of investigational product Femildo(TM) in management of sexual dysfunction in women
- Conditions
- Hypoactive Sexual Desire Disorder (HSDD)
- Registration Number
- CTRI/2019/01/016868
- Lead Sponsor
- ADSO Naturals Holdings BV
- Brief Summary
Sexual dysfunction is highly associated with a number of dissatisfying personal experiences and relationships. A recent national survey found all categories of sexual dysfunction in women to have strong positive associations with low feelings of physical and emotional satisfaction and low feelings of happiness. Further, sexual dysfunction in women occurs more frequently than in men and thus potentially has a more negative impact upon their quality of life. Hypoactive sexual desire disorder (HSDD), the most prevalent female sexual health problem, was considered the persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity with marked distress or interpersonal difficulty not otherwise accounted for by a general medical or psychiatric condition. An HSDD may be primary or secondary, lifelong or acquired, or generalized or situational.
Several validated instruments for diagnosing HSDD now exist. For example, questionnaires such as the Brief Profile of Female Sexual Function (B-PFSF©) have been validated in the clinical setting for the diagnosis of HSDD. Hand in hand with the use of such tools is the need to establish a detailed history, in order to identify comorbidities or external causes. As there is no drug approved by the FDA for the treatment of sexual dysfunction in women, women often turn to over-the-counter remedies that promise to improve sexual functioning. There are many such remedies on the market today, but few have clinical trials to support their claims. Fortunately, women with low drive levels can get treatment to overcome the problem.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Female
- 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.
- 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.
- 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. Baseline Visit(Day 1), Day 30 and End of visit (Day 90)
- Secondary Outcome Measures
Name Time Method Monitoring of Adverse Event Baseline Visit(Day 1), Day 30, Day 60 and End of visit (Day 90)
Trial Locations
- Locations (2)
Narayana Super Speciality Hospitals
🇮🇳Bangalore, KARNATAKA, India
Skinovate Laser & Cosmetic Surgery Centre
🇮🇳Pune, MAHARASHTRA, India
Narayana Super Speciality Hospitals🇮🇳Bangalore, KARNATAKA, IndiaDr V NarayanaswamyPrincipal investigator9448053952leelahospitalvns@gmail.com