PKB171 Against Placebo in Couples With Mild Male Factor Infertility

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Infertility Due to Azoospermia

In brief

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, despite several protocol amendments. PKB171 gel was well tolerated and revealed no safety concerns as assessed by AEDTs, local IMP tolerability, analytical parameters, vital signs, physical and gynecological examination, or transvaginal ultrasound findings. The aim of this clinical trial is to assess the safety and efficacy of the gel PKB171 compared to a placebo gel in couples with mild male factor infertility, unable to conceive in the last 6 and 24 months. Additionally, the safety and local tolerability of Gel PKB171 will be further investigated.

Key facts

Study ID

NCT07669584

Run by

Prokrea BCN, S.L.

People needed

732

Starts

2025-10-28

Expected to finish

2027-10-28

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 38. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects eligible for inclusion in this study must meet all the following criteria:
• Written informed consent form signed before any study test or procedure.
• Unable to conceive for more than 6 months and less than 24 months, despite regular and adequate unprotected sexual intercourse.
• Willing and able to comply with the protocol.
• Female subjects with the following criteria:
• Age ≥ 18 and ≤ 38 years.
• Regular spontaneous menstrual cycles with a 25- to 35-day length (intercycle variation less than 5 days) within the last six cycles before the first visit.
• Normal uterine cavity shown on transvaginal sonography.
• Normal ovarian reserve, demonstrated by AMH ≥ 1 ng/ml at day 2-5 of the cycle.
• Antral follicle count (sum of both ovaries) ≥ 6
• Male subjects with the following criteria:
• Age ≥ 18 and ≤ 50 years.
• Spermiogram with semen volume ≥ 1mL, concentration > 11 M/mL, < 42% total mobility and normal forms ≥ 2%

You may not qualify if…

• Subjects eligible for this study, both women and men, must not meet any of the following criteria:
• Body mass Index (BMI) < 18 and ≥ 32 kg/m².
• Any sexual intercourse with another partner (other than corresponding trial subject) within 12 weeks entry in the study and during it.
• Couples who had any previous assisted reproductive technology (ART) cycle (in vitro fertilization, IVF, or intracytoplasmic sperm injection, ICSI) before inclusion into the trial.
• Active hepatitis B, C, HIV, genital herpes, Chlamydia, Gonorrhea or Syphilis infection.
• History of malignant disease (cancer). Previous or planned chemotherapy or radiotherapy.
• History of cerebral or retinal hemorrhage, acute myocardial infarction.
• In females: Prohibited concomitant intravaginal products or procedures.
• Hypersensitivity or intolerance to pentoxifylline, xanthine derivatives or any of the excipients of the IMP.
• Employees of the investigator or trial center, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial center, as well as family members of the employees or the principal investigator.
• People committed to an institution by virtue of an order issued either by the judicial or other authorities.
• Reasonable expectation that the subject will not be able to satisfactorily complete the study:
• History of current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or give informed consent.
• History of alcohol or drug abuse that would interfere with the subject's ability to comply with protocol requirements.
• Receipt of any investigational drug within three months of screening visit.
• Previous enrolment in this trial.
• Documented noncompliance.
• Any other condition of the subject that in the opinion of the investigator may compromise evaluation of the trial treatment or may jeopardize subject's safety or compliance to protocol requirements.
• Patients with peptic ulcers or recent history thereof.
• Patients with haemorrhage (e.g. extensive retinal bleeding) or at risk of increased bleeding
• Patients with severe coronary artery disease, when in the physician's judgement myocardial stimulation might prove harmful.
• Patients with severe hepatic and renal impairment.
• Patients without adequate laboratory parameters according to the normal ranges of local laboratory.
• Female risk factors of infertility defined by any of the following:
• Absence of any or both ovaries.

Where it is running

• Clinica Universidad de Navarra — Pamplona, Navarre, Spain (enrolling)
• Hospital del Mar — Barcelona, Spain (enrolling)
• Clinica Sagrada Familia — Barcelona, Spain (enrolling)
• Hospital Universitario San Rafael — Madrid, Spain (enrolling)
• Clinica Universidad de Navarra — Madrid, Spain (enrolling)
• Hospital Universitario Nuestra Señora de Valme — Seville, Spain (enrolling)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
• HM Gabinete Médico Velázquez — Madrid, Spain
• Clinica Fertty — Barcelona, Spain
• Hospital Universitario L Paz — Madrid, Spain
• Assir Dreta-Cap Pare Claret — Barcelona, Spain
• Assir Dreta-Cap Roger de Flor — Barcelona, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.