PKB171 Against Placebo in Couples With Asthenozoospermia Who Wish to Conceive

NCT06986031 | Terminated Phase 2

• 2 other identifiers: PKB171-022016-003993-42
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Infertility, Male; asthenozoospermia; pentoxifylline

Outcome Measures

Primary Outcomes (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

  In case pregnancy was detected after the double-blind post-treatment period by a positive pregnancy test, the fetal heart activities were examined by transvaginal ultrasound (TVUS)

  9 months

Secondary Outcomes (2)

• Local IMP tolerability

  4 months

• Safety up to three treatment cycles with PKB171 vaginal gel.

  4 months

Study Arms (3)

Gel PKB171 150 mg (equivalent to 3% pentoxifylline)

EXPERIMENTAL

Intravaginal application of Gel PKB171 3% with a single-use applicator (syringe). The content of the applicator (5 g) was inserted as deep as possible into the vagina, and the female rested for at least 45 minutes in bed.

Drug: Vaginal product

Gel PKB171 200 mg (equivalent to 4% pentoxifylline)

EXPERIMENTAL

Intravaginal application of Gel PKB171 4% with a single-use applicator (syringe). The content of the applicator (5 g) was inserted as deep as possible into the vagina, and the female rested for at least 45 minutes in bed.

Drug: Vaginal product

Gel PKB171 placebo

PLACEBO COMPARATOR

Intravaginal application of Gel PKB171 placebo with a single-use applicator (syringe). The content of the applicator (5 g) was inserted as deep as possible into the vagina, and the female rested for at least 45 minutes in bed.

Drug: Vaginal product

Interventions

Vaginal product DRUG

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

Gel PKB171 150 mg (equivalent to 3% pentoxifylline); Gel PKB171 200 mg (equivalent to 4% pentoxifylline); Gel PKB171 placebo

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- For the couple:
• Unable to conceive for at least 12 months, despite regular and adequate unprotected sexual intercourse.
• Willing and able to comply with the protocol
• \- For the male subjects:
• 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%
• Viable spermatozoa at least 45% -For the female subjects:
• Female subjects aged 18-37 years.
• BMI 18-30 kg/m2
• Regular spontaneous menstrual cycles between 21 and 35 days in length (intercycle variations not more than +/- days) with the last six cycles before visit VS1.
• Presence of both ovaries.

You may not qualify if:

• For the couple:
• Any sexual intercourse with another partner (other than corresponding trial subject) within 12 weeks before VS1 and willing to continue until VT3.
• 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.
• Aromatase inhibitors.
• Oral pentoxifylline.
• Non-medical practitioners consultations in regards to fertility.
• Change in intake regimen of the following therapies within 14 days before visit VS1 until last treatment visit:
• Herbal supplements, such as ginseng, maca or yohimbe.
• Dietary supplements, such as vitamins, selenium, zinc, carnitine, folic acid or coenzyme Q.
• Infection with human immunodeficiency virus (HIV), hepatitis B or C, genital herpes, chlamydia, gonorrhoea or syphilis.

Sponsors & Collaborators

• Prokrea BCN, S.L.: lead

Study Sites (1)

José Maria Palacios

Barcelona, 08009, Spain

Location

MeSH Terms

Conditions

Infertility, Male; Asthenozoospermia

Interventions

Menstrual Hygiene Products

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Feminine Hygiene Products; Equipment and Supplies

Study Officials

• José M Palacios, MD

  Prokrea BCN, S.L.

  STUDY CHAIR

• Sara Peralta, MD

  Hospital Clinic i provincial de Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: May 22, 2025
• Study Start: May 8, 2017
• Primary Completion: January 23, 2019
• Study Completion: May 24, 2019
• Last Updated: May 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)