Pharmacokinetic, Clinical, Hormonal and Therapeutic Effects of the Use of Estradiol and Testosterone Hormonal Subdermal Implants in Women With Natural Menopause, Premature Ovarian Failure or Surgical Menopause Due to Cervical Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Evaluate hormonal, metabolic thromboembolic and clinical effects on climacteric symptoms
研究概览
简要总结
Estrogen and androgen deficiencies negatively impact the quality of life of women at different stages of life, especially after menopause. New modalities and new therapeutic alternatives have been researched. Parenteral administration of estradiol and testosterone could be effective to treat symptoms secondary to estrogen and androgen deficiencies and minimize these adverse events. This study evaluates the efficiency of subdermal implant-bioabsorbable use in women with menopausal symptoms associated with secondary estrogen and androgen deficiencies in women with natural menopause, premature ovarian failure or surgical menopause due to cervical cancer. Pharmacokinetic, biochemical, metabolic, thromboembolic and hormonal data will be evaluated, as well as the effects on quality of life, menopausal symptoms and sexual function after treatment.
详细描述
The clinical study will be carried out on 140 women, who will be divided into three groups: (1) postmenopausal women with menopausal and sexual symptoms (n=60); (2) women with premature ovarian failure (n=40); (3) women with cervical cancer undergoing abdominal hysterectomy with bilateral adnexectomy, with menopausal and sexual symptoms (n=40).
All participants will answer questionnaires to assess quality of life, menopausal symptoms and sexual function. All participants will undergo general physical and gynecological examinations, as well as hormonal, biochemical, thromboembolic and imaging tests.
The study will last six months. The included participants will undergo the following visits: inclusion (post-selection) and 1, 3 and 6 months after implant insertion. For the pharmacokinetic study, blood samples will be collected at the following periods: inclusion (before implant placement) and after 1h, 2h, 3h, 6h and 12h; one week, two weeks and one month after placement, and then monthly until six months after implant insertion, to evaluate serum levels of Luteinizing hormone, Follicle stimulating hormone, estradiol, estrone, total testosterone and sex hormone-binding globulin.
Clinical, biochemical, hormonal and therapeutic parameters will be evaluated before placement (inclusion) and after 3 and 6 months. The Mann Whitney test will be applied to evaluate differences between measurements and the chi-square test will be applied to analyze the proportions of improvement between groups before and after treatment.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •menopause time of 2 to 6 years;
- •Body Mass Index between 25 and 30 kg/m2;
- •women hysterectomized and ovariectomized due to cervical cancer;
- •women with premature ovarian failure and under 40 years of age;
- •active sex life;
- •absence of severe depression and anxiety, confirmed by evaluation using the Beck (specific for depression) and Beck (specific for anxiety) questionnaires.
排除标准
- •disabling illnesses;
- •use of medications that inhibit sexual desire;
- •inability to answer the questionnaires;
- •altered routine exams and comorbidities:
- •Severe hypertension with Blood Pressure measurement > 160 x 90 mmHg in two measurements
- •clinical or subclinical thyroid dysfunction with Thyroid-stimulating hormone > 4 mIU/L
- •dyslipidemia - fasting triglyceride level > 400 mg/dL
- •presence of occult blood in feces
- •hyperprolactinemia (>29ng/mL)
- •fasting blood glucose > 100 mg/dL
- •presence of osteopenia or osteoporosis
- •BIRADS classification greater than or equal to 3 on mammography
- •presence of endometrial echo > 4mm on transvaginal ultrasound
- •presence of changes in oncotic colpocytology
- •diagnosis after psychological screening of moderate to severe anxiety/depression.
研究组 & 干预措施
Testosterone
Subdermal implant-bioabsorbable testosterone pellet (100 mg of testosterone)
干预措施: testosterone pellet (100 mg) (Drug)
Placebo
Subdermal implant-bioabsorbable placebo pellet (cholesterol)
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluate hormonal, metabolic thromboembolic and clinical effects on climacteric symptoms
时间窗: 6 months
evaluate concentration in serum of luteinizing hormone, follicle stimulating hormone, estradiol, estrone, total testosterone and sex hormone-binding globulin.
次要结局
- Evaluate response in quality of life and sexual function(6 months)
研究者
Edmund Baracat
Professor
University of Sao Paulo General Hospital