Status:
TERMINATED
PKB171 Against Placebo in Couples With Asthenozoospermia Who Wish to Conceive
Lead Sponsor:
Prokrea BCN, S.L.
Conditions:
Infertility, Male
Eligibility:
All Genders
18-37 years
Phase:
PHASE2
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...
Detailed Description
Multicentre, randomised, double-blind, placebo-controlled, parallel-group trial in couples who both wish to procreate with each other. A couple consists of a male subject with asthenozoospermia and a ...
Eligibility Criteria
Inclusion
- \- 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.
- Normal uterine cavity as assessed by transvaginal sonography at VS1. No submucosal fibroids or intramural fibroids exceeding 4 cm in diameter.
- Normal findings at hysterosalpingography. If results from within the last 24 months are available, the examination witll not be repeted at VS2.
- AMH blood level \> 1.0 ng/mL measured at VS1
- Antral follicle count (sum of both ovaries) \> 7 measured at VS2. If results the last 6 months are available, the examination will not be repeated at VS2.
Exclusion
- 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.
- 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.
- 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.
- History of malignant disease (cancer). Previous or planned chemotherapy or radiotherapy.
- History of cerebral or retinal haemorrhage, acute myocardial infarction, severe cardiac arrhythmia or severe hepatic impairment.
- Family history of genetic risk factors concerning pregnancy or birth. Known abnormal karyotype.
- Any other condition of the subject that in the opinion of the investigator may compromise evaluation of the trial treatment or may jeopardise subject's safety, compliance or adherence to protocol requirements.
- Previous enrolment in this trial, or participation in any other clinical trial within the past 30 days prior to enrolment.
- Employees of the investigator or trial centre, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial centre, as well as family members of the employees or the principal investigator.
- Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
- Exclusion criteria for males:
- Varicocele, as confirmed by physical and ultrasound examination.
- Exclusion criteria for females:
- History of anovulation. History of or known current poly-cystic ovary syndrome (PCOS), endometriosis type III or IV according to the American Society for Reproductive Medicine (ASRM) criteria, or fallopian tube obstruction.
- Previous gynaecological surgery. One Caesarian section more than two years prior to VS1 and/or myomectomy more than 6 months prior to VS1 will be permitted.
- History of three or more clinical or preclinical (absence of gestational sac) miscarriages.
- Induced or spontaneous abortion within one year prior to VS1.
- Prohibited concomitant therapies within 14 days before visit VS1 until last treatment visit: Any intravaginal preparations including, but not limited to, intravaginal prescription or over-the-counter medications, vaginal lubricants, vaginal moisturizers or vaginal douches.
- Pregnancy or lactation.
- Any contraindication to becoming pregnant.
- Abnormal cervical smear (Bethesda classification AGC, LSIL or HSIL; PAP 3 or higher) during screening period. Cervical smear results from within the previous 12 months prior to VS1 are acceptable if the report is available to the investigator.
- Additional exclusion criterion for females at visit VR:
- Pregnancy.
Key Trial Info
Start Date :
May 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06986031
Start Date
May 8 2017
End Date
May 24 2019
Last Update
May 22 2025
Active Locations (1)
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1
José Maria Palacios
Barcelona, Spain, 08009