A Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.
In plain words A Phase 2 study of flower pollen extract in female participants 45 to 65, run by Graminex LLC. It plans to enroll about 120 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 45 to 65; healthy volunteers accepted. Conditions: Menopausal Women.
- Females between 45-60 years of age, inclusive
- BMI 18.5 kg/m2 - 34.9 kg/m2 inclusive
- Self-reported menopausal women who have not had a menstrual period for >12 months prior to screening and are experiencing at least moderate menopausal symptoms as assessed by the total MRS score of ≥9 at screening
- Presence of menopausal symptoms for at least six months prior to screening including, vasomotor symptoms (hot flushes, sweating) AND at least two of the following symptoms: sleep disturbance, joint pain, mood changes, fatigue and lack of…
4 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Graminex WSPE; Graminex LSPE; Placebo
Registered summary
The goal of this study is to investigate the effect of pollen extracts on menopausal symptoms in healthy women The main question it aims to answer is: What is the difference in change in severity of menopausal symptoms as assessed by the total Menopause Rating Scale (MRS) score from baseline at Week 36 between Graminex Water Soluble Pollen Extract (WSPE), Lipid Soluble Pollen Extract (LSPE), and Placebo? Participants will be asked to complete the MRS assessment tool to rate their menopausal symptoms while receiving either WSPE, LSPE, or Placebo.
Where, as registered
No US site; Canada (1).