A Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms

Physician Recommended Nutriceuticals

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Menopause

Treatments: Dietary Supplement: proprietary formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02497560

PRN 20144

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 3 patient groups, including a placebo group

Treatment

Active Comparator group

Description:

all natural dietary supplement

Treatment:

Dietary Supplement: proprietary formula

Treatment + Omega-3s

Other group

Description:

all natural dietary supplement + omega-3s

Treatment:

Dietary Supplement: proprietary formula

Placebo

Placebo Comparator group

Description:

vegetable oil

Treatment:

Dietary Supplement: proprietary formula