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Clinical Trials/CTRI/2024/05/067134
CTRI/2024/05/067134
Not yet recruiting
Phase 1

An Open-Label, Single Arm Clinical Study to Evaluate the Safety, Efficacy and Tolerability of HSLG-032303 in Healthy Adult Males with Low Libido. - NI

Himalaya Wellness Company0 sites0 target enrollmentTBD
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Himalaya Wellness Company
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Male subjects aged 21 to 50 years with general good health.
  • •2\.Healthy subjects as determined by the investigator based on a medical evaluation including medical history, physical and laboratory examinations.
  • •3\.Subjects with Sexual Desire Inventory (SDI) Scale score 45 or lower indicating low sexual desire/ low libido.
  • •4\.Subjects willing to sign an informed consent document.
  • •5\.Subjects willing to adhere to protocol requirements throughout the study period.
  • •6\.Subjects who have not participated in any clinical study in the past 30 days.

Exclusion Criteria

  • •1\.Subjects with known clinically significant cardiovascular, neurological, respiratory, gastrointestinal, genitourinary, congenital or any other disorder as determined by the investigator that may interfere with the study outcome or put the subjects in medical risk.
  • •2\.Subjects with any other sexual disorders like Erectile Dysfunction (ED), Pre\-Mature Ejaculation (PME) or subjects taking any other medications like vasodilators, PDE\-5 inhibitors, prostaglandins, or any other herbal or dietary supplement for sexual wellness within past one month.
  • •3\.Subject with any other significant cause of low libido like social, personal, or cultural which in the opinion of the investigator may interfere with the study results.
  • •4\.Subjects with known history or present condition of allergic response to the study drug or any ingredients in the investigational product.
  • •5\.Pre\-existing systemic diseases (auto immune disorders, hormonal replacement, etc.) necessitating long\-term medications.
  • •6\.Male subjects who refrain to use adequate contraception and donate sperm from first admission to the study until 90 days after the follow\-up visit.
  • •7\.Known alcohol or any other substance abuse according to DSM\-V criteria
  • •8\.Any other reason (physical, psychological, or social) that can interfere with the subject’s compliance to the study in the opinion of the Investigator.

Outcomes

Primary Outcomes

Not specified

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