Evaluación de la Eficacia Del Uso de "HIFAS MENOPAUSE" en la Calidad de Vida de Mujeres Postmenopáusicas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline in menopause-related quality of life assessed with the short-form Cervantes scale
研究概览
简要总结
This single-center, single-group, open-label study evaluated changes in menopause-related quality of life and menopausal symptoms in postmenopausal women aged 40 to 60 years after 24 weeks of treatment with HIFAS MENOPAUSE.
Participants took two capsules of HIFAS MENOPAUSE orally once daily while fasting for 24 weeks. Study assessments were performed at baseline and after 4, 12, and 24 weeks of treatment. The primary objective was to evaluate change in menopause-related quality of life using the short-form Cervantes Scale. Additional assessments included menopausal symptom severity, weekly hot-flash frequency, difficulty concentrating, vulvovaginal health, vaginal pH, cytological maturation, treatment adherence, tolerability, satisfaction, and adverse events.
详细描述
This was a prospective, single-center, single-group, open-label, pre-post interventional study conducted in postmenopausal women with mild to moderate menopausal symptoms. The study included no concurrent control group, and each participant served as her own control.
Eligible participants were postmenopausal women aged 40 to 60 years whose last menstrual period had occurred at least 12 months before screening. Participants received HIFAS MENOPAUSE, a dietary supplement, at a dose of two oral capsules once daily while fasting for 24 weeks.
Study visits were conducted at the following time points:
Baseline, before starting treatment Week 4 Week 12 Week 24
Menopause-related quality of life was assessed using the short-form Cervantes Scale. Menopausal symptom severity was evaluated using the Menopause Rating Scale. Other assessments included weekly hot-flash frequency recorded in a participant diary, difficulty concentrating measured using a visual analog scale, vaginal pH, the Vaginal Health Index, and the cytological maturation index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women, defined as having had their last menstrual period at least 12 months before screening.
- •Age 40 to 60 years, inclusive.
- •Vaginal pH ≥
- •Menopause Rating Scale (MRS) total score ≥
- •Willing and able to provide written informed consent, take HIFAS MENOPAUSE, complete the study questionnaires, records, and diaries, and attend all scheduled study visits.
- •Willing to discontinue prebiotic supplements and foods containing added prebiotics or live and active cultures for a 4-week washout period before enrollment.
排除标准
- •Menopause induced by total or partial hysterectomy, chemotherapy, or radiotherapy.
- •Use of natural health products intended to treat menopausal symptoms, including phytoestrogens, black cohosh, dehydroepiandrosterone (DHEA), dong quai, vitamin E at doses greater than 250 IU/day, or high consumption of soy-based foods, unless the required washout period had been completed.
- •Current or previous menopausal hormone therapy for menopausal symptoms, unless the required washout period had been completed.
- •Acute vaginal infection, urinary tract infection, genital bleeding of unknown origin, or another clinically relevant gynecological condition.
- •Use of vaginal medications, vaginal douches, moisturizers, or gels containing lidocaine or other analgesic products intended to reduce pain during sexual intercourse within 1 week before enrollment or during the study.
- •Previous diagnosis of hyperparathyroidism or hyperthyroidism.
- •Participation in another clinical study within the previous 6 months.
- •History of alcohol or drug abuse within the 12 months before screening.
- •History of cancer within 5 years before screening, except localized nonmetastatic skin cancer.
- •History of any clinically significant disease or disorder that, in the investigator's opinion, could place the participant at risk, affect the study results, or impair the participant's ability to complete the study.
- •History or presence of gastrointestinal, hepatic, or renal disease, or another condition known to interfere with the absorption, distribution, metabolism, or excretion of medicinal products, including Crohn disease, short bowel syndrome, acute or chronic pancreatitis, or pancreatic insufficiency.
- •History of bariatric surgery, including gastric bypass or gastric banding.
- •Current consumption of more than two standard alcoholic drinks per day. One standard drink was defined as 355 mL of beer, 150 mL of wine, or 45 mL of spirits.
- •Difficulty swallowing large tablets or a large number of tablets.
- •Any condition or abnormality that, in the investigator's opinion, could compromise participant safety or the quality of the study data.
研究组 & 干预措施
HIFAS MENOPAUSE
Participants received HIFAS MENOPAUSE, a symbiotic dietary supplement, at a dose of two capsules orally once daily while fasting for 24 weeks. Outcomes were assessed at baseline and at weeks 4, 12, and 24. No concurrent comparator or control arm was included.
干预措施: HIFAS MENOPAUSE (Dietary Supplement)
结局指标
主要结局
Change from baseline in menopause-related quality of life assessed with the short-form Cervantes scale
时间窗: Baseline and Weeks 4, 12, and 24
Change from baseline in the total score of the 16-item short-form Cervantes Scale, used to assess menopause-related quality of life. The total score ranges from 0 (minimum) to 80 (maximum). Higher scores indicate a greater negative impact of menopause on quality of life, representing a worse outcome. Therefore, a decrease from baseline indicates improvement.
次要结局
- Participant satisfaction with HIFAS MENOPAUSE(Weeks 4, 12, and 24)
- Weekly hot flash frequency(Weeks 4, 12, and 24)
- Change from baseline in difficulty concentrating(Baseline and Weeks 4, 12, and 24)
- Change from baseline in vulvovaginal health assessed with the Vaginal Health Index(Baseline and Weeks 4, 12, and 24)
- Change from baseline in vaginal pH(Baseline and Weeks 4, 12, and 24)
- Change from baseline in the percentage of superficial vaginal cells(Baseline and Week 24)
- Change from baseline in the percentage of intermediate vaginal cells(Baseline and Week 24)
- Change from baseline in the percentage of basal and parabasal vaginal cells(Baseline and Week 24)
- Number of participants with adverse events(From the first dose through Week 24)
- Participant-reported tolerability of HIFAS MENOPAUSE(Weeks 4, 12, and 24)
- Treatment adherence(Weeks 4, 12, and 24)
- Change from baseline in menopausal symptom severity assessed with the menopause rating scale(Baseline and Weeks 4, 12, and 24)
- Change from baseline in difficulty concentrating assessed with the Visual Analog Scale for difficulty concentrating(Baseline and Weeks 4, 12, and 24)
- Participant-reported tolerability of HIFAS MENOPAUSE assessed with the study-specific tolerability scale(Weeks 4, 12, and 24)
- Participant satisfaction with HIFAS MENOPAUSE assessed with the study-specific satisfaction scale(Weeks 4, 12, and 24)