A study to see how Vigorvolt tablet helps men with low sexual desire and low energy.

A Prospective, Open-Label, Single-Arm, Single-Centre, Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Vigorvolt in Male Subjects with Low Libido and Vitality - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/098051

Enrollment

Registered

2025-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Health Condition 1: F520- Hypoactive sexual desire disorder Health Condition 2: R538- Other malaise and fatigue

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male Participants aged 21 to 55 years at the time of consent. 2. Documented low serum total testosterone (less than or equal to 300 ng/dL), confirmed by a morning (08:00 10:00) sample at Screening. 3. Self-reported symptoms of low libido and vitality, including at least one of the following for greater than or equal to 3 months: o Decreased sexual drive or reduced initiation of sexual activity. o Difficulty in becoming sexually aroused. o Fatigue and low energy levels. 4. Willingness to comply with the study protocol, including scheduled visits, treatment plan, laboratory tests, and other procedures. 5. Able to provide written informed consent prior to initiation of any study-related procedures.

Exclusion criteria

Exclusion criteria: 1. History of psychiatric illness (e.g., major depression, psychosis) or alcohol dependence. 2. Established or known organic pathology for sexual dysfunction (e.g., severe endocrinopathies, untreated hypogonadism requiring TRT, significant prostatic disease). 3. Body Mass Index (BMI) greater than 37 kg/m at Screening. 4. Severe lower urinary tract infection and/or clinically significant prostate enlargement (per investigator s judgment). 5. Current or recent (within 6 months prior to Screening) use of long-acting intramuscular testosterone undecanoate or testosterone pellets. 6. Evidence of renal, hepatic, or cardiac failure. 7. Known HIV infection. 8. Participation in any other interventional clinical trial within the last 3 months. 9. Use of any other investigational drug within 1 month prior to randomization.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of Vigorvolt in improving libido after 2 months of administration, measured by changes in serum total testosterone levels from baseline to Day 60.Timepoint: Visit 1 Day -14 to -1 Visit 2 Day 0 Visit 3 Day 30 3 days Visit 4 Day 60 3 days	—

Secondary

Measure	Time frame
1.To assess the effect of Vigorvolt on sexual desire, measured by the Sexual Desire Inventory (SDI). 2. To evaluate the effect of Vigorvolt on fatigue and vitality, assessed using the Fatigue Severity Scale (FSS). 3. To assess the safety and tolerability of Vigorvolt by monitoring adverse events (AEs), vital signs, physical examinations, and laboratory parameters (CBC and serum testosterone).Timepoint: Visit 1 Day -14 to -1 Visit 2 Day 0 Visit 3 Day 30 3 days Visit 4 Day 60 3 days	—

Measure

Time frame

1.To assess the effect of Vigorvolt on sexual desire, measured by the Sexual Desire Inventory (SDI). 2. To evaluate the effect of Vigorvolt on fatigue and vitality, assessed using the Fatigue Severity Scale (FSS). 3. To assess the safety and tolerability of Vigorvolt by monitoring adverse events (AEs), vital signs, physical examinations, and laboratory parameters (CBC and serum testosterone).Timepoint: Visit 1 Day -14 to -1 Visit 2 Day 0 Visit 3 Day 30 3 days Visit 4 Day 60 3 days

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Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com9739001749

Outcome results