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A Comparison of Three Treatment options for Improving Sexual Function and Semen Quality in Men with Age-Related Low Testosterone

Prospective comparative study on the role of tadalafil and clomiphene citrate on sexual function and semen quality in patients with late onset hypcgonadism (LOH). - Nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/102689
Enrollment
135
Registered
2026-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: E291- Testicular hypofunction

Interventions

Intervention1: Tadalafil 5mg: Tab Tadalafil 5mg once daily for 6 months Intervention2: Clomiphene Citrate 50 mg: Clomiphene Citrate 50mg once daily for 6 months Intervention3: Combination therapy: Tad

Sponsors

Department of Urology IPGMER and SSKM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cinical features of Late onset hypogonadism, Two serum testosterone level less than 300ng/dl, IIEF5 score less than 21, Normal Semen volume and sperm presence

Exclusion criteria

Exclusion criteria: Primary testicular failure FSH more than 15, Prior use of testosterone, Hcg, Clomiphene or PDE5inhibhitor for past 6 months, PSA more than 4 or active prostate malignancy, Severe Hepatic or renal impairment(eGFR less than 30), CVA disease, Azoospermina, prior vasectomy, Uncontrolled Diabetes, Active psychiatric illness

Design outcomes

Primary

MeasureTime frame
IIEF5 score, semen concentration and motilityTimepoint: At baseline, 3 months, 6 months

Secondary

MeasureTime frame
serum total testosterone, LH, and FSH levelTimepoint: at 3 and 6 months

Countries

India

Contacts

Public ContactAbhishek Gupta

IPGMER And SSKM Hospital Kolkata

dr.soumya.mondal@gmail.com9433119700

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026