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The Efficacy of Graminex® Flower Pollen Extracts in Healthy Women With Urinary Incontinence

NCT05510999 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2022-08-22

No results posted yet for this study

Summary

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).

Conditions

Interventions

OTHER

Placebo

One capsule of placebo will be taken twice daily for 24 weeks.

DIETARY_SUPPLEMENT

Water soluble pollen extract fraction

Each capsule contains 180 mg of water soluble pollen extract fraction. One capsule will be taken twice daily (360 mg/day) for 24 weeks.

DIETARY_SUPPLEMENT

Lipid soluble pollen extract fraction + water soluble pollen extract fraction

Each capsule contains a combination of 9 mg of lipid soluble pollen extract fraction and 180 mg of water soluble pollen extract fraction. One capsule will be taken twice daily (18 mg/day and 360 mg/day, respectively) for 24 weeks.

DIETARY_SUPPLEMENT

Lipid soluble pollen extract fraction

Each capsule contains 9 mg of lipid soluble pollen extract fraction. One capsule of will be taken twice daily (18 mg/day) for 24 weeks.

DIETARY_SUPPLEMENT

Water soluble pollen extract fraction + cranberry powder

Each capsule contains a combination of 42 mg of water soluble pollen extract and 125 mg of cranberry powder. One capsule will be taken twice daily (84 mg/day and 250 mg/day, respectively) for 24 weeks.

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • Graminex LLC

    lead OTHER

Principal Investigators

  • David Crowley · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2021-10-26
Completion
2021-10-26

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05510999 on ClinicalTrials.gov