PKB171 Against Placebo in Couples With Asthenozoospermia Who Wish to Conceive (NCT06986031) | Clinical Trial Compass
TerminatedPhase 2
PKB171 Against Placebo in Couples With Asthenozoospermia Who Wish to Conceive
Stopped: The trial was teriminated early due to low subject recruitment and high screening failure rates, despite several protocol modifications.
Spain60 participantsStarted 2017-05-08
Plain-language summary
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 first trial performed in Spain, 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.
The aim of this clinical trial is to test if treatment with Gel PKB171 increases pregnancy rate in couples with reduced mobility of sperm (so-called asthenozoospermia). Additionally, the safety and local tolerability of Gel PKB171 was further investigated.
Who can participate
Age range18 Years – 37 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Unable to conceive for at least 12 months, despite regular and adequate unprotected sexual intercourse.
✓. Willing and able to comply with the protocol
✓. Male subjects aged 18-50 years.
✓. Two semen analyses, both with the following results:
✓. Total number of spermatozoa at least 12.000.000 per ejaculation
✓. Progressive motility less than 32%
✓. Total motility less than 40%
✓. Normal forms at least 2%
Exclusion criteria
✕. Any sexual intercourse with another partner (other than corresponding trial subject) within 12 weeks before VS1 and willing to continue until VT3.
✕. Couples who had any unsuccessful previous assisted reproductive technology (ART) cycle (in vitro fertilisation, IVF, or intracytoplasmic sperm injection, ICSI) before inclusion into the trial, where unsuccessful is defined as no embryo transfer or no pregnancy was achieved. Former ART cycles, which resulted in live birth do not count.
What they're measuring
1
Efficacy assessed by rate o clinical pregnancies with fetal heart beat) of up to three treatment cycles with PKB171 vaginal gel compared to placebo vaginal gel in couples with asthenozoospermia
✕. Hypersensitivity or intolerance to pentoxifylline, xanthine derivatives or any of the excipients of the IMP.
✕. Heavy consumer of stimulating drinks (more than five cups of coffee, tea, chocolate or cola drinks per day, or more than one can \[250 mL\] of energy drink per day). Daily consumption of more than 24 g alcohol per day. Smoker with more than five cigarettes per day, including portions of smokeless tobacco, nicotine patches and electronic cigarettes.
✕. Any active substance abuse of drugs, medications or alcohol within the last five years.
✕. Prohibited concomitant therapies within 28 days before visit VS1 until last treatment visit:
✕. Any preparations with sex hormones or modulators of the genital system.
✕. Selective estrogen receptor modulators (SERMs), such as tamoxifen or clomifene.