Menopause
Conditions
Brief summary
This is a randomized, masked, placebo controlled study to assess the effect on a nutritional dietary supplement on menopausal signs and symptoms in perimenopausal women.
Interventions
DIETARY_SUPPLEMENTproprietary formula
Sponsors
Physician Recommended Nutriceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age group between 45 and 65 at the time of informed consent. * Physician diagnosis of menopause. * History of substantial hot flashes \> 4 episodes /day for last 2 weeks. * Being post-menopausal with an intact uterus. * Subject has provided signed and dated written informed consent before admission to the study.
Exclusion criteria
* Concurrent hot flash therapies (prescription medications including hormone replacement therapies, gabapentin or over the counter supplements), vaginal hormonal products (rings, creams, gels) or transdermal estrogen or estrogen/progestin products for 30 days before screening visit. * Women currently or previously on anticoagulants, Vitamin K antagonists like warfarin in the past 3 months, or expected to be on anticoagulants in the near future. * Women involved in other clinical studies within the last 30 days. * Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hot flashes episodes | 12 weeks | Diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Work productivity | 12 weeks | Questionnaire |
| Quality of Life | 12 weeks | Questionnaire |
Countries
United States
Outcome results
None listed