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NCT05510999
The Efficacy of Graminex® Flower Pollen Extracts in Healthy Women With Urinary Incontinence
Phase 2 trial testing Placebo in Urinary Incontinence in 190 participants. Completed in 26 October 2021.
26 October 2021
Quick facts
| Lead sponsor | Graminex LLC |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 190 |
| Start date | 17 June 2019 |
| Primary completion | 26 October 2021 |
| Estimated completion | 26 October 2021 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Placebo
- Water soluble pollen extract fraction
- Lipid soluble pollen extract fraction + water soluble pollen extract fraction
- Lipid soluble pollen extract fraction
- Water soluble pollen extract fraction + cranberry powder
Conditions studied
- Urinary Incontinence — all drugs for Urinary Incontinence →
Sponsor
Graminex LLC
Who can join
Adults 40 to 75, female only, with Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this study is to investigate the effect of Graminex® Flower Pollen Extracts in healthy women with urinary incontinence. The change in severity of urinary incontinence between baseline and 24 weeks will be assessed by an International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and compared between the investigational product and placebo groups. Additionally, the safety and tolerability of Graminex® Flower Pollen Extracts, as compared to placebo, will be measured by the occurrence of and/or changes in treatment-emergent adverse events (AEs).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy of nonsolvent flower pollen extracts in healthy women with urinary incontinence: A randomized, double-blind, placebo-controlled, parallel study.
Moulin M, Lewis ED, Crowley DC, May CE, et al · · 2024 · PMID 39219633 · DOI 10.1097/cu9.0000000000000248
Verify or expand the search:
- PubMed search for NCT05510999
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05510999 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Graminex LLC
- Last refreshed: 22 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05510999.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing