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PKB171 Against Placebo in Couples With Asthenozoospermia Who Wish to Conceive

NCT06986031 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-22

No results posted yet for this study

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.

Conditions

  • Infertility, Male

Interventions

DRUG

Vaginal product

Intravaginal application of gel PKB171 with a single-use applicator (syringe)

Sponsors & Collaborators

  • Prokrea BCN, S.L.

    lead INDUSTRY

Principal Investigators

  • José M Palacios, MD · Prokrea BCN, S.L.

  • Sara Peralta, MD · Hospital Clinic i provincial de Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
37 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2019-01-23
Completion
2019-05-24

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06986031 on ClinicalTrials.gov