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CTRI Number  CTRI/2019/01/016868 [Registered on: 03/01/2019] Trial Registered Prospectively
Last Modified On: 21/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study of evaluate the efficacy and safety of investigational product Femildo(TM) in management of sexual dysfunction in women 
Scientific Title of Study   A Randomized, Double Blinded, Placebo Controlled Study to evaluate the efficacy and safety of investigational product Femildo(TM) in management of sexual dysfunction in women  
Trial Acronym  Femildo study 
Secondary IDs if Any  
Secondary ID  Identifier 
BIAG-CSP-014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V Narayanaswamy 
Designation  Senior Consultant 
Affiliation  Narayana Super Speciality Hospitals 
Address  24, 9th Cross Road, Margosa Road, HN Layout, Malleshwaram West, Bangalore, Karnataka 560003
24, 9th Cross Road, Margosa Road, HN Layout, Malleshwaram West, Bangalore, Karnataka 560003
Bangalore
KARNATAKA
560003
India 
Phone  9448053952  
Fax    
Email  leelahospitalvns@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shalini Dayananda 
Designation  General Manager  
Affiliation  BioAgile Therapeutics Pvt Ltd  
Address  2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bangalore - 560094
2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bangalore - 560094
Bangalore
KARNATAKA
560094
India 
Phone  08043754520  
Fax    
Email  pm@bioagiletherapeutics.com  
 
Details of Contact Person
Public Query  
Name  Divya C  
Designation  Director  
Affiliation  BioAgile Therapeutics Pvt Ltd  
Address  2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bangalore - 560094
2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bangalore - 560094
Bangalore
KARNATAKA
560094
India 
Phone  08043754520  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
Sponsored trial  
 
Primary Sponsor
Modification(s)  
Name  ADSO Naturals Holdings BV 
Address  Zuthpensweg 55 7418 AH Deventer, The Netherlands 
Type of Sponsor  Other [Nutraceutical Product Manufacturing Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr V Narayanaswamy  Narayana Super Speciality Hospitals  24, 9th Cross Road, Margosa Road, HN Layout, Malleshwaram West, Bengaluru, Karnataka 5600034
Bangalore
KARNATAKA 		 9448053952

leelahospitalvns@gmail.com 
Dr Sonal Shendkar  Skinovate Laser & Cosmetic Surgery Centre  Taluka-Haveli Third Floor, ‘Royal Avenue’, Survey No.18 Hissa No.11/6, Next to Hotel ‘Shivar Garden Pimple Saudagar, Rahatani, Maharashtra 411017
Pune
MAHARASHTRA 		 9960178611

shendkar.sonal82@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
ACE Independent Ethics Committee  Approved 
Lifepoint Research Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hypoactive Sexual Desire Disorder (HSDD) 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Femildo Capsules  Two 250 mg capsules to be taken twice daily (Morning after breakfast and night after dinner) 
Comparator Agent  Starch from Corn  Two 250 mg capsules to be taken twice daily (Morning after breakfast and night after dinner) 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  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.
 
 
ExclusionCriteria 
Details  • 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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
Monitoring of Adverse Event  Baseline Visit(Day 1), Day 30, Day 60 and End of visit (Day 90) 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/01/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
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.
 
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