Trial · NCT06986031
PKB171 Against Placebo in Couples With Asthenozoospermia Who Wish to Conceive
NCT06986031, Phase 2, Terminated, Prokrea BCN, S.L.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PKB171 Against Placebo in Couples With Asthenozoospermia Who Wish to Conceive. Trials, record NCT06986031. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06986031
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PKB171 Against Placebo in Couples With Asthenozoospermia Who Wish to Conceive
- NCT number
- NCT06986031
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Prokrea BCN, S.L.
- Conditions
- Infertility, Male
- Interventions
- Vaginal product
- First posted
- 2025-05-22
- Last updated
- 2025-05-22
- Other registries' IDs
- eudract:2016-003993-42
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 9 months | 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) |
| Secondary | Local IMP tolerability | 4 months | Local IMP tolerability within 4 hours after each IMP administration up to three treatment cycles with PKB171 vaginal gel compared to placebo vaginal gel in couples with asthenozoospermia. Local tolerability included five parameters: Reddening, itching, burning sensation, pain, pain urination. |
| Secondary | Safety up to three treatment cycles with PKB171 vaginal gel. | 4 months | All AEs, including SAEs,ocurring within the period of observation for the clinical trial were recorded |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06986031
GET https://conductscience.org/api/trials/v1/NCT06986031/registered