Trials / Completed
CompletedNCT05510999
The Efficacy of Graminex® Flower Pollen Extracts in Healthy Women With Urinary Incontinence
A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Efficacy of Graminex® Flower Pollen Extracts in Healthy Women With Urinary Incontinence.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 190 (actual)
- Sponsor
- Graminex LLC · Academic / Other
- Sex
- Female
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-06-17
- Primary completion
- 2021-10-26
- Completion
- 2021-10-26
- First posted
- 2022-08-22
- Last updated
- 2022-08-22
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT05510999. Inclusion in this directory is not an endorsement.