Condition: Infertility Due to Azoospermia · Sponsor: Prokrea BCN, S.L.
The test medication Gel PKB171 is a vaginal gel that has not yet been licensed by the regulatory authorities. However, the active substance pentoxifylline has been available as tablets for decades and is used to increase peripheral blood flow in patients with circulation problems. Additionally, pentoxifylline is used to treat sperm samples in artificial insemination and test tube fertilisation to increase the mobility of sperm. A phase I clinical trial, 30 women were treated with Gel PKB171 for up to three times. Gel PKB171 was generally well tolerated and the most common side effects were local reactions like vaginal discharge and itching. A phase II clinical trial, investigate the efficacy and safety of two concentrations of PKB171 versus placebo in couples with asthenozoospermia who wish to conceive. A total of 72 couples were planned to be included in the study. Finally, 28 couples were enrolled, and 11 couples were randomised. Within this trial, two concentrations of pentoxifylline gel were compared (5 mL of gel PKB171 containing 150 mg (3%) of pentoxifiylline, and 5 mL of gel PKB171 containing and 200 mg (4%) of pentoxifylline. Both doses were tolerated well and revealed no safety concerns as assessed by AEs, local Gel PKB171 tolerability, laboratory parameters, vital signs, gynaecologic and physical examination, or transvaginal ultrasound findings. This study was prematurely discontinued due to low numbers of eligible subjects and high recruitment failure rates, desp…
This description comes directly from the study's public registry record.
Elena Vernet Arias, MD, PhD · +34 661 378 408 · elena@prokreabcn.com
Miquel Raurell, MD · +34 93 417 09 11 · miquel@prokreabcn.com
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| Clinica Universidad de Navarra | Pamplona, Navarre, Spain | Recruiting |
| Hospital del Mar | Barcelona, Spain | Recruiting |
| Clinica Fertty | Barcelona, Spain | Not Yet Recruiting |
| Clinica Sagrada Familia | Barcelona, Spain | Recruiting |
| Assir Dreta-Cap Pare Claret | Barcelona, Spain | Not Yet Recruiting |
| Assir Dreta-Cap Roger de Flor | Barcelona, Spain | Not Yet Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona, Spain | Not Yet Recruiting |
| HM Gabinete Médico Velázquez | Madrid, Spain | Not Yet Recruiting |
| Hospital Universitario San Rafael | Madrid, Spain | Recruiting |
| Clinica Universidad de Navarra | Madrid, Spain | Recruiting |
| Hospital Universitario L Paz | Madrid, Spain | Not Yet Recruiting |
| Hospital Universitario Nuestra Señora de Valme | Seville, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07669584