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A single-center randomized controlled safety and efficacy research of tadalafil in the treatment of infertile patients with ED

A single-center randomized controlled safety and efficacy research of tadalafil in the treatment of infertile patients with ED

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045253
Enrollment
Unknown
Registered
2021-04-09
Start date
2021-04-02
Completion date
Unknown
Last updated
2021-11-16

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

Conditions

Male infertility

Interventions

Tadalafil group :Tadalafil

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1.Aged 20-55 years, male; 2.The body is generally healthy and has a stable heterosexual partner for more than 3 months; 3.The patient has a normal sexual life and has not taken contraceptive measures for 6 months and above without contraception and infertility; 4.Check if the partner's reproductive function is abnormal; 5.The total number of forward motile sperm >= 5 x 10^6; 6.The patient did not use drugs to improve sperm quality within one month before entering the clinical study, or used it, but the one-month washout period has ended; 7.Using the International Index of Erectile Function (IIEF-5) to diagnose ED, patients with mild to moderate ED (IIEF-5 between 11 and 25); 8.Those who have not used PDE5i or other ED treatment methods within 2 weeks before grouping; 9.The patient voluntarily participated and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Those who take anti-epileptic, anti-tumor and other drugs that affect spermatogenesis; 2.Patients with congenital testicular dysplasia, testicular atrophy, seminal tract obstruction, and varicocele; 3.Exclude patients with serious systemic diseases such as mental illness, cardiovascular and cerebrovascular diseases, liver and kidney insufficiency; 4.Endocrine ED caused by severe endocrine disorders or abnormal sex hormones or ED caused by neurological factors; 5.Vascular ED caused by penile artery and cavernous lesions; 6.Anyone with severe mental illness, spinal cord injury, abnormal penile anatomy, or suffering from penile hemangioma; 7.Use anti-androgens and androgen drugs; coagulation dysfunction and use anticoagulants (such as Coumadin) and other drug-induced ED; 8.Those who are known to be allergic to the research drug and its excipients.

Design outcomes

Primary

MeasureTime frame
total mobile sperm count;

Countries

China

Contacts

Public ContactLi Zheng

Shanghai General Hospital

lizhengboshi@163.com+86 13564783816

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026