A study to evaluate the efficacy of Investigational Drug M. Libido, in Enhancing Testosterone Level and Improving Sperm Profile in Male Volunteers
- Registration Number
- CTRI/2019/01/016876
- Lead Sponsor
- Aurea Biolabs Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 60
1.Male subjects of age range between 21-55 years olds
2.Healthy heterosexual males interested in increasing libido
3.Committed sexual relationship for at least 6 months
4.Sexually active for the last 6 months
5.Stable, sexual relationship for the duration of the study
6.Total testosterone levels within the healthy reference range (Endocrine Society) at screening (264 - 916 ng/dL) â?? could target men at lower end of the healthy testosterone range (low normal).
•Allergy or intolerance to study ingredients
•Any physical unavailability to sexual partner during duration of study
•Any physical disability that limits sexual function
•Treatment or therapy for sexual disorder during the last 6 months
•Prescribed medication for anticoagulation therapy.
•Diagnosed with any medical disorders or diseases such as severe renal/hepatic insufficiency, psychiatric disorders, prostatic cancer or benign hypertrophy, acute genitourinary disorder or any other conditions that identify the subject as unhealthy for the study or interfere with any study parameters.
•Diagnosed with hypertension and receiving medications for hypertension
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in serum levels of total and free testosterone levels <br/ ><br>2.Change in sexual function: International Index of Erectile Dysfunction (IIEF) <br/ ><br>3.Change in Quality of Life: SF-36 questionnaire <br/ ><br>Timepoint: week 4 week 8 and week 12
- Secondary Outcome Measures
Name Time Method Change from baseline in hematology and biochemistry parameters between treatmentsTimepoint: week 4 week 8 and week 12