Clinical trial NCT06432816: Efficacy of Nano-Pso Therapy in Menopause
Official title: Efficacy of Nano-Pso Therapy Compared to Placebo in the Control of Vasomotor Symptomatology in Early Menopause
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menopause
Vasomotor; Syndrome
Lead sponsor: Distribuidora Biolife SA de CV
Sponsor class: INDUSTRY
First posted: 2024-05-29
Enrollment: 90
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter, prospective, analytical and longitudinal study. A sample calculation was made with a therapeutic efficiency of 30% in vasomotor syndrome, with a result of 210 participants, divided into 3 institutions.
Primary purpose: TREATMENT

Brief summary: Vasomotor syndrome is prevalent in 85% of postmenopausal women, hormone therapy in menopause is first-line therapy, but 38% of patients have some contraindication for its use. The medications indicated in this population presents adverse reactions, such as dryness of the mucous membranes, and insomnia in patients, and triggers to abandoned treatment due to poor response to the drug. Aligned with the safety of patients, we wish to test pomegranate seed oil with nanotechnology (NANOPSO), which has been reported to have positive results at a central level, due to its antioxidant effect, which could impact women in climacteric in a positive way. The study involves the participation of 90 patients divided into two groups, where placebo or Nano-PSO will be administered for 60 days, with a total follow-up of 120 days. It is established that patients must not have received previous treatments for menopausal symptoms. Therefore, it is expected that therapy with NANO-PSO compared to placebo will be more effective in controlling vasomotor symptoms in early menopause after 6 months of treatment evaluated by the MRS scale.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* In perimenopause with vasomotor syndrome and score greater than 15 points staged with the MRS scale
* They agree to participate and sign the consent informed.
* Without prior treatment to relieve the symptoms of menopause.

Exclusion Criteria:

* - With pharmacological and/or hormonal therapy prescribed for menopause symptoms.
* With psychiatric pathologies such as anxiety and depression.
* Hysterectomized patients or patients with induced menopause surgically early.
* Smoking
* Malnutrition or low weight determined by a BMI ≤ 18.5Kg/m2

Elimination criteria.

* Who do not attend follow-up to provide their treatment the 1, 2, 3 and 4 months for application of the MRS scale
* That they leave the study voluntarily.
* Who present any serious adverse effect to the drug.

Primary outcomes:
measure: MENOPAUSE RATING SCALE
timeFrame: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
measure: FSH HORMONE
timeFrame: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
measure: PITTSBURG SCALE
timeFrame: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
measure: STRAW+10
timeFrame: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
Secondary outcomes:
measure: PHQ-9
timeFrame: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
measure: ESTRADIOL
timeFrame: EVALUATION WILL BE CARRIED OUT AFTER SIX MONTHS.
Other outcomes:
Locations:
city: Toluca
country: Mexico
facility: Maternal and Child Institute of the State of Mexico
state: State OF Mexico
Study officials:
affiliation: Maternal and child institute of the State of Mexico
name: ARACELI ESPINOSA GUERREO
role: PRINCIPAL_INVESTIGATOR
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