Transdermally Applied Estradiol Delivery In Ultra-Safe Medications Valuable In Treatment Against Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Patients' statisfaction
研究概览
简要总结
Endometriosis is a chronic, estrogen-dependent disease affecting women of reproductive age, associated with pelvic pain, infertility, and reduced quality of life. Progestins are the standard first-line therapy, but long-term treatment requires well-tolerated regimens that balance efficacy with patient satisfaction.
This study will compare two combinations of progestins with natural transdermal estradiol-dienogest versus drospirenone-to evaluate which regimen provides greater patient satisfaction after 6 months of therapy.
详细描述
Endometriosis is a chronic, estrogen-dependent disorder characterized by the presence of endometrial tissue outside the uterine cavity. This ectopic tissue induces chronic inflammation, fibrosis, and adhesions, often resulting in pelvic pain, dysmenorrhea, dyspareunia, infertility, and impaired quality of life. The condition affects an estimated 6-10% of women of reproductive age, with peak prevalence between 25 and 35 years, making it one of the most common gynecological diseases with significant social and economic impact.
Available treatments for endometriosis are symptomatic rather than curative. Medical management is considered the cornerstone of therapy, especially in women who are not seeking immediate pregnancy. Current guidelines recommend progestins as first-line treatment due to their proven efficacy in suppressing endometriosis-associated pain and their favorable safety and tolerability profile. However, because therapy is usually long-term until menopause and continuous, optimal regimens must combine efficacy with good tolerability and sustained patient satisfaction.
Dienogest is an established fourth-generation progestin widely used in endometriosis management, with well-documented efficacy and safety. Drospirenone, another fourth-generation progestin, combines progestogenic, anti-androgenic, and anti-mineralocorticoid activities. Although marketed primarily as a contraceptive, drospirenone has shown promising results in controlling endometriosis symptoms and improving patient-reported outcomes.
Progestin-only regimens may lead to hypoestrogenic adverse effects, including vaginal dryness, mood disturbances, reduced libido, irregular bleeding, and bone loss. For this reason, the addition of natural estradiol is considered advantageous, as it may prevent atrophic changes, support bone metabolism, and improve overall quality of life. Transdermal estradiol, in particular, avoids hepatic first-pass metabolism, does not induce prothrombotic liver factors, and is associated with a lower risk of thromboembolic events compared with ethinyl estradiol.
This observational study is designed to directly compare two therapeutic strategies for women with endometriosis: Dienogest + transdermal estradiol or Drospirenone + transdermal estradiol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women who have been on combination therapy for at least 6 months with progestin and transdermal natural oestrogen (Dienogest + transdermal oestradiol or Drospirenone + transdermal oestradiol);
- •women who have performed follow-up at least 6 months after the start of treatment and for whom data on the primary endpoint of the study (treatment satisfaction) are available.
排除标准
- •absence of surgical diagnosis or imaging indicative of endometriosis or adenomyosis;
- •women who have taken GnRH analogue therapy within 6 months prior to treatment with dienogest + transdermal oestradiol vs. drospirenone + transdermal oestradiol
- •women who have taken only progestogen therapy without transdermal oestradiol or with contraindications to oestrogen use;
- •women who received surgical indications during the treatment period, including obstructive uropathy or symptomatic bowel stricture; evidence of complex ovarian cysts or ovarian endometriomas with a diameter greater than 5 cm on transvaginal ultrasound.
研究组 & 干预措施
Women with endometriosis undergoing medical management
This cohort will include women of reproductive age with a confirmed diagnosis of endometriosis, either by laparoscopy/histology or by validated imaging techniques (e.g., transvaginal ultrasound, MRI).
干预措施: Drospirenone 4 mg orally (Drug)
Women with endometriosis undergoing medical management
This cohort will include women of reproductive age with a confirmed diagnosis of endometriosis, either by laparoscopy/histology or by validated imaging techniques (e.g., transvaginal ultrasound, MRI).
干预措施: Dienogest 2 mg orally (Drug)
结局指标
主要结局
Patients' statisfaction
时间窗: This outcome will be evaluated after at least 6 months of treatment
Therapy satisfaction will be assessed by means of a 5-level Likert scale (very satisfied; satisfied; neither satisfied nor dissatisfied; dissatisfied; very dissatisfied). Women expressing the judgement 'very satisfied' and 'satisfied' will be considered to be globally satisfied, similarly to reported in the study on which the calculation of the sample size is based. The outcome will be dichotomised (very satisfied + satisfied versus neither satisfied nor dissatisfied + dissatisfied + very dissatisfied). The level of statisfaction in the two groups will be compared as the proportion of satisfied women in each treatment group, reported as frequencies and percentages and analyzed accordingly.
次要结局
- Therapeutic efficacy - symptoms control (NRS)(This outcome will be evaluated after at least 6 months of treatment)
- Therapeutic efficacy - symptoms control (use of analgesics)(This outcome will be evaluated after at least 6 months of treatment)
- Therapeutic efficacy - ovulation suppression(This outcome will be evaluated after at least 6 months of treatment)
- Therapeutic efficacy - amenorrhea achievement and bleeding pattern(This outcome will be evaluated after at least 6 months of treatment)
- Sexual function(This outcome will be evaluated after at least 6 months of treatment)
- Treatment adherence(This outcome will be evaluated after at least 6 months of treatment)
- Global Impression of Change(This outcome will be evaluated after at least 6 months of treatment)
- Mood changes(This outcome will be evaluated after at least 6 months of treatment)
- Health-related quality of life (HRQoL)(This outcome will be evaluated after at least 6 months of treatment)
- Acceptance of transdermal therapy(This outcome will be evaluated after at least 6 months of treatment)
- Adverse events(This outcome will be evaluated after at least 6 months of treatment)