Health TrialsbyHealthPanel

PKB171 Against Placebo in Couples With Mild Male Factor Infertility

ConditionInfertility Due to Azoospermia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-38
SponsorProkrea BCN, S.L.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Age ≥ 18 and ≤ 38 years.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Intravaginal gel

    Drug

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

  • Vaginal Gel with Applicator

    Drug

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

Treatment groups

732 Participants
are divided into 2 treatment groups
Group A: Gel PKB171 200 mg (equivalent to 4% pentoxiphylline)Experimental treatment 1 intervention
Group B: Gel PKB171 placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

To assess the efficacy up to three treaament cycles with Gel PKB171 compared with placebo in couples with mild male factor fertility

Heartbeat by the 6th-8th weeks of gestation by ecography

Time frame
6-8 weeks

Secondary outcomes

1

To assess the efficacy of PKB171 gel compared to placebo on biochemical pregnancy rate

Positive serum β-hCG test detects the hormone human chorionic gonadotropin in blood

Time frame
6-8 months
2

To assess the efficacy of PKB171 gel compared to placebo on ongoing pregnancy rate

Confirmed fetal heartbeat after 20 weeks of gestation by ecography

Time frame
12 months
3

To assess the efficacy of PKB171 gel compared to placebo on live birth rate.

Live birth rate is the percentage of all attempts that lead to successful births

Time frame
9 months
4

To assess the pregnancy loss rate after PKB171 gel treatment compared to placebo on-viable intrauterine pregnancy up to 20 weeks

The pregnancy loss rate is the percentage of recognized pregnancies that end in spontaneous miscarriage before the fetus is viable (typically before 20 to 23 weeks of gestation

Time frame
9 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prokrea BCN, S.L.

Lead sponsor

Source ClinicalTrials.gov
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