Efficacy of Nano-Pso Therapy Compared to Placebo in the Control of Vasomotor Symptomatology in Early Menopause
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- MENOPAUSE RATING SCALE
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The treatments were received, previously labeled and randomly drawn by the sponsor.
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •- 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.
- •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.
结局指标
主要结局
MENOPAUSE RATING SCALE
时间窗: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
THE MRS IS A SCALE TO IDENTIFY THE FREQUENCY AND INTENSITY OF MENOPAUSE SYMPTOMS
FSH HORMONE
时间窗: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
Follicle-stimulating hormone (FSH) is a pituitary hormone that regulates the reproductive cycle, helps control the menstrual cycle and the production of eggs in the ovaries.
PITTSBURG SCALE
时间窗: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire commonly used to evaluate sleep quality in adults. Created by the Department of Psychiatry at the University of Pittsburgh in 1988, the PSQI addresses both qualitative and quantitative aspects of sleep experienced during the month prior to its administration.
STRAW+10
时间窗: 1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.
The STRAW+10 system is a clinical and objective way to stage patients transitioning to menopause.
次要结局
- PHQ-9(1 BASELINE EVALUATION WILL BE CARRIED OUT AFTER 3 AND SIX MONTHS.)
- ESTRADIOL(EVALUATION WILL BE CARRIED OUT AFTER SIX MONTHS.)
研究者
Dra Araceli Espinosa Guerrero
DRA. Araceli Espinosa Guerrero
Distribuidora Biolife SA de CV