The menopausal transition in women marks the end of female reproductive capacity and is
associated with an estrogenic hormonal imbalance that begins to be noticeable around the
fifth decade of life. This process, also known as climacteric, involves the transition from
an active to an inactive reproductive stage, and can last for several years before menopause,
which is defined as the last menstruation .
During the climacteric, the reduction of estrogen triggers clinical signs and symptoms that
affect various systems of the body, such as the central nervous system, the cardio-metabolic
system, the musculoskeletal system, and sexual function. Vasomotor symptoms, such as hot
flashes, are common manifestations at this stage and affect approximately 75-80% of women in
the transition to menopause, with an intensity ranging from moderate to severe in most cases.
These symptoms can have a negative impact on quality of life, affecting sleep, functional
capacity and work attendance .
Menopausal hormone therapy (MHT) with estrogens and progesterone is the first line of
treatment for vasomotor symptoms in menopause. However, some women cannot or prefer not to
use MHT due to its adverse effects, which has led to the development of second-line
therapies, such as selective serotonin reuptake inhibitors, gabapentinoids, clonidine, and
oxybutynin. These non-hormonal therapies may also have minor side effects that may lead to
discontinuation of treatment.
In the search for therapeutic alternatives with fewer adverse effects, compounds such as
punic acid (omega 5) and its metabolites, such as conjugated linoleic acid, have been
investigated. Nanoemulsified pomegranate seed oil (omega 5) has been shown to be a compound
with high antioxidant capacity and neuroprotective effects, making it a promising option for
the management of symptoms associated with menopause, especially those related to alterations
at the level of the menopause. central. Preliminary studies have shown encouraging results in
animal models and initial clinical trials, suggesting the need for additional research in
specific populations, such as menopausal women.
GENERAL OBJECTIVE
Compare 6-month NANO-PSO therapy versus placebo in the control of vasomotor symptoms in early
menopause, assessed via the Menopause Rating Scale.
SPECIFIC OBJECTIVES
- Describe the sociodemographic and clinical characteristics of the Study population.
- Analyze vasomotor symptoms in menopausal patients at baseline with the MRS scale.
- Compare vasomotor symptoms with the use of NANO-PSO vs. Placebo
- Compare the percentage of treatment response regarding vasomotor symptoms with the use
of nano pso vs placebo at 3 and 6 months.
Population study Patients who come first class. outpatient climacteric consultation that
presents with early menopause and MRS scale > 15 points without treatment.
With a sample convenience, the aim is to recruit 45 patients per group with a total of 90
patients. Intervention by compounds - Leading to treatment of NANO-PSO or Oil of pomegranate
seed with nanotechnology, they are capsules with a net content of 640 mg with a dosage
indicated by sponsor of 2 capsules in fast
- Placebo physically identical to NANO-PSO capsules: Soft gelatin capsules 640 mg edible oil
35for PLACEBO being the following information: Oil edible, oval shape, 640 mg.
Distribuidora Biolife SA de CV
1Research sites
90Patients around the world
This study is for people with
Climacteric
Vasomotor syndrome
Menopause
Requirements for the patient
To 55 Years
Female
Medical requirements
Sites
Instituto Materno Infantil del Estado de Mexico
Recruiting
P.º Cristóbal Colón 311 B, Residencial Colón y Col Ciprés, 50120 Toluca de Lerdo, Méx., Mexico