A Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms
Phase 2
Terminated
- Conditions
- Menopause
- Registration Number
- NCT02497560
- Lead Sponsor
- Physician Recommended Nutriceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Hot flashes episodes 12 weeks Diary
- Secondary Outcome Measures
Name Time Method Work productivity 12 weeks Questionnaire
Quality of Life 12 weeks Questionnaire
Trial Locations
- Locations (2)
Comprehensive Women's Care
🇺🇸Colorado Springs, Colorado, United States
Dittrich Clinic
🇺🇸Philadelphia, Pennsylvania, United States
Comprehensive Women's Care🇺🇸Colorado Springs, Colorado, United States