FindTrial
Sign In

A study of evaluate the efficacy and safety of investigational product Femildo(TM) in management of sexual dysfunction in women

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 - Femildo study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/016868
Enrollment
24
Registered
2019-01-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Femildo Capsules: Two 250 mg capsules to be taken twice daily (Morning after breakfast and night after dinner) Control Intervention1: Starch from Corn: Two 250 mg capsules to be taken t

Sponsors

ADSO Naturals Holdings BV
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: • 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Monitoring of Adverse EventTimepoint: Baseline Visit(Day 1), Day 30, Day 60 and End of visit (Day 90)—

Countries

India

Contacts

Public ContactDivya C

BioAgile Therapeutics Pvt Ltd

pm@bioagiletherapeutics.com08043754520

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026