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A study to evaluate the efficacy of Investigational Drug M. Libido, in Enhancing Testosterone Level and Improving Sperm Profile in Male Volunteers

A Prospective, Double Blinded, Randomized, Comparative Study to Evaluate the Efficacy of Investigational Drug M. Libido, in Enhancing Testosterone Level and Improving Sperm Profile in Male Volunteers. - Male Libido

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/016876
Enrollment
60
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: M.libido: The product is a natural product and intended for enhancing Testosterone Level and Improving Sperm Profile. to be taken orally once daily for 3 months Control Intervention1: P

Sponsors

Aurea Biolabs Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: •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

Design outcomes

Primary

MeasureTime frame
1.Change in serum levels of total and free testosterone levels 2.Change in sexual function: International Index of Erectile Dysfunction (IIEF) 3.Change in Quality of Life: SF-36 questionnaire Timepoint: week 4 week 8 and week 12—

Secondary

MeasureTime frame
Change from baseline in hematology and biochemistry parameters between treatmentsTimepoint: week 4 week 8 and week 12—

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