A Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.
ConditionMenopausal Women
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorGraminex LLC
About this trial
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.
Eligibility criteria
Qualifiers
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 energy, vaginal dryness, urinary changes, and changes in sexual function
Disqualifiers
Females who have had unilateral oophorectomy or hysterectomy or uterine ablation
Allergy (including bee products or pollen, sensitivity, or intolerance to investigational products or placebo ingredients
Ongoing diagnosis with anxiety disorder, sleep disorder, or major depression as assessed by the QI
Ongoing unstable diagnosis of musculoskeletal disorders as assessed by the QI
Trial design
Treatments tested in this trial
- Graminex WSPE
- Graminex LSPE
- Placebo
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Graminex LLC
Lead sponsor
KGK Science Inc.
Collaborator
Source ClinicalTrials.gov