Clinical trial to assess the efficacy and safety of a post-coital intravaginal gel of PKB171 in couples with mild male factor infertility.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Prokrea Bcn S.L.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]

Trial duration

28 Oct 2025 → ongoing

Decision date (initial)

2025-08-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Prokrea BCN S.L

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Efficacy (Clinical pregnancy defined as intrauterine pregnancy with confirmed heartbeat by the 6th-8th weeks of gestation) up to three treatment cycles of the Gel PKB171 compared to placebo vaginal gel in couples with mild male factor infertility.

Secondary objectives 6

1. To assess the efficacy of PKB171 gel compared to placebo on biochemical pregnancy rate (positive serum β-hCG test)
2. To assess the efficacy of PKB171 gel compared to placebo on ongoing pregnancy rate (confirmed fetal heartbeat after 20 weeks of gestation).
3. To assess the efficacy of PKB171 gel compared to placebo on live birth
4. To assess the pregnancy loss rate (non-viable intrauterine pregnancy up to 20 weeks) after PKB171 gel treatment compared to placebo
5. To compare the obstetrics characteristics of pregnancies achieved after PKB171 gel compared to placebo, including gestational age at delivery, mode of delivery (vaginal birth vs cesarean section), the incidence of obstetric complications such as preterm birth, preeclampsia, placenta previa, small-for-gestational-age or growth restriction, and large-for-gestational-age and the incidence of fetal anomalies, including structural and/or chromosomal/genetic abnormalities.
6. To assess the safety and local tolerability of PKB171 gel, including: o Local and systemic adverse events in both male and female participants. o Safety laboratory parameters and vital signs monitoring.

Conditions and MedDRA coding

Oligospermia and/or asthenozoospermia

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Written informed consent form signed by the participant couple
2. Unable to conceive for more than 6 months and less than 24 months, despite regular and adequate unprotected sexual intercourse.
3. Willing and able to comply with the protocol.
4. Females 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 first visit. • Normal uterine cavity shown on transvaginal sonography. • Normal ovarian reserve, demonstrated by AMH ≥ 0,8 ng/ml (valid result within 4 months before inclusion) • Antral follicle count (sum of both ovaries) ≥ 6
5. 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% (valid result within 4 months before inclusion)

Exclusion criteria 18

1. Body mass Index (BMI) < 18 and ≥ 32 kg/m².
2. People committed to an institution by virtue of an order issued either by the judicial or other authorities.
3. 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.
4. Patients with peptic ulcers or recent history thereof.
5. Patients with haemorrhage (e.g. extensive retinal bleeding) or at risk of increased bleeding
6. Any sexual intercourse with another partner (other than corresponding trial subject) within 12 weeks entry in the study and during it.
7. Couples who had any previous assisted reproductive technology (ART) cycle (in vitro fertilization, IVF, or intracytoplasmic sperm injection, ICSI) before inclusion into the trial.
8. Active hepatitis B, C, HIV, genital herpes, Chlamydia, Gonorrhea or Syphilis infection.
9. History of malignant disease (cancer). Previous or planned chemotherapy or radiotherapy.
10. History of cerebral or retinal hemorrhage, acute myocardial infarction.
11. In females: Prohibited concomitant intravaginal products or procedures.
12. Hypersensitivity or intolerance to pentoxifylline, xanthine derivatives or any of the excipients of the IMP.
13. 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.
14. Patients with severe coronary artery disease, when in the physician’s judgement myocardial stimulation might prove harmful.
15. Patients with severe hepatic and renal impairment.
16. Patients without adequate laboratory parameters according to the normal ranges of local laboratory (valid results within 4 months before inclusion).
17. Female risk factors of infertility defined by any of the following: • Absence of any or both ovaries. • Abnormal uterine cavity assessed by transvaginal sonography. Specially, submucosal fibroids, intramural fibroids affecting the uterine cavity (any size), more than 5 intramural fibroids ≥ 4 cm in diameter, or more than 6 intramural fibroids of any size. Women with any subserosal fibroid ≥ 8cm will also be excluded. • Risk factors for fallopian tube obstruction as abdominal surgery, diseases such as endometriosis, tuberculosis, ruptured appendix or peritonitis, Pelvic Inflammatory Disease (PID), Chlamydia and gonorrhea. • Antecedents of long-term amenorrhea, polycystic ovarian syndrome, type III or IV endometriosis, or fallopian tube obstruction. • Previous gynecological surgery, excluding caesarean section or myomectomy within predefined limits. • For women, prohibited concomitant therapies within 28 days before enrolled into the study until last treatment visit: sex hormones, selective estrogen receptor modulators, aromatase inhibitors or oral pentoxifylline. • Two or more clinical or preclinical spontaneous miscarriages. • Lactation or pregnancy. • Known abnormal karyotype
18. Male risk factors of infertility defined by any of the following: • Vasectomy • Known genetic abnormalities related to infertility: i. Endocrine or systemic disorders causing hypergonadotropic hypogonadism (either, congenital or acquired). ii. Known abnormal karyotype • Previously diagnosed varicocele • The use of certain drugs (e.g., anabolic steroids, antineoplastic agents, erythromycin, tetracycline, gentamycin). • Viral process with fever ≥ 38ºC in the past 70 days

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Rate of clinical pregnancies defined as intrauterine pregnancy with confirmed fetal heartbeat by the 6-8th week of gestation.

Secondary endpoints 12

1. Rate of Biochemical pregnancy: positive pregnancy test (blood β-hCG)
2. Rate of Pregnancy loss: nonviable intrauterine pregnancy up to 20 weeks gestation
3. Ongoing pregnancy: positive heartbeat at ultrasound after 20 weeks of gestation
4. Gestational age at delivery
5. Mode of delivery (vaginal delivery / C-section)
6. Incidence of obstetric complications: preterm birth; preeclampsia; placenta previa; small-for-gestational age or growth restriction; large-for-gestational age
7. Fetal anomalies: any fetal anomaly (altered system and description of the anomaly), diagnostic of chromosomal or genetic abnormalities (yes/no; if yes, details of the anomaly)
8. Live birth (yes/no)
9. Local tolerance.
10. Adverse events.
11. Safety laboratory.
12. Vital signs.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Prokrea Bcn S.L.

Sponsor organisation

Prokrea Bcn S.L.

Address

Calle Del Consejo De Ciento 375

City

Barcelona

Postcode

08009

Country

Spain

Scientific contact point

Organisation

Prokrea Bcn S.L.

Contact name

Clinical Manager

Public contact point

Organisation

Prokrea Bcn S.L.

Contact name

Clinical Manager

Third parties 1

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications