Use of Estriol at Distal Third of the Vaginal Wall Relieving Coital Pain in Women After Menopause: a Randomized, Blinded and Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Improvement in pain score after estriol use
研究概览
简要总结
Hypoestrogenism leads to vaginal wall changes resulting in diminished vaginal lubrication and, consequently, causing pain during intercourse. Topical estrogen therapy (THT) may control this complaint. However, there are limitations on its use, especially in patients with breast cancer and diagnosed endometrial cancer. This randomized clinical trial aims to assess the impact of local estriol therapy in postmenopausal women complaining of coital pain and to assess serum concentrations of estriol in these women after estriol use. One-hundred-thirty-two women aged between 40 and 65 years will be randomized into three groups: Women using estriol 1 mg / 1g at the proximal third of vagina every other night - estriol proximal group (PEG), women in using estriol 1 mg / 1g at the distal third of the vagina every other night - estriol distal group (DEG), gel group (GG) using water-based during intercourse.
详细描述
Introduction The daily application of estrogen in the vagina can improve the hydrogen potential (pH), vaginal dryness, burning sensation, dyspareunia, and urinary symptoms. Dyspareunia is highly prevalent after menopause as well as in women after gynecological and breast cancer treatment. However, prescription of topical estrogen therapy (THT) to these women is still controversial, and they are allowed to use only moisturizing cream and vaginal lubricants.
Studies have shown increased serum concentrations of estrogens (estradiol and estrone) after intravaginal suppository containing estradiol use. However, a cohort of 13,479 women treated for breast cancer, 271 received topical hormone therapy (THT), and no increased risk for recurrence was shown in this population.
The main blood supplement to the vagina is mainly from vessels that irrigate proximal vaginal wall, a region where possibly the drug uptake is more intense. However, one study showed that the concentration of estradiol is similarly high regardless of whether the drug was applied to the proximal or distal wall of the vagina. Nevertheless, this study has not been replicated yet.
THT promotes an improvement of coital pain when used in the proximal vagina, but a large population of women with clinical conditions such as thrombophilia and breast cancer cannot benefit from this resource. It is not known if the estriol applied in the distal vagina wall can lead to high serum levels of this hormone.
OBJECTIVES This study aims to evaluate the impact of topic estriol therapy applied in distal vagina wall in coital pain, sexual function, and mood after estriol use. To evaluate serum level of this hormone after estriol use.
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
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with a clinical diagnosis of menopause
- •FSH> 40 milli-International unit (mIU/ml)
- •Having sex including penetration of penis into vagina
- •Pain during penetration
- •Active sexual partners
- •Stable relationship.
排除标准
- •Previous use of steroids in genital area in the last month
- •Thromboembolism history
- •Renal insufficiency
- •Cholestatic jaundice
- •Degenerative vulvar pathology
- •Breast cancer
- •Endometrial cancer
- •Vulvar cancer
- •Vaginal cancer history
- •Prior radiotherapy to the genital region
- •Acute urogenital infections
- •Vulvovaginitis
- •Urinary tract infection
- •Genital herpes
- •Genital prolapse grades II, III and IV by Baden Walker
- •Systemic hormonal therapy in the last three months
- •Use of antidepressants drugs
- •Thyroid disorder
- •Cognitive restrictions
研究组 & 干预措施
proximal estriol group (PEG )
This arm is composed of women using estriol 1 mg / 1g in the proximal third of vagina every other night
干预措施: Estriol (Drug)
distal estriol group (DEG)
This arm is composed of women using estriol 1 mg / 1g in the distal third of the vagina every other night
干预措施: Distal estriol (Drug)
Control group (CG)
This arm is composed of women using vaginal gel lubricant base water during intercourse
干预措施: Vaginal Gel (Drug)
结局指标
主要结局
Improvement in pain score after estriol use
时间窗: baseline and 12 weeks
Number of women with lower score of pain assessed by the McGill Pain Questionnaire
次要结局
- Number of participants with risk for anxiety after estriol use(baseline and week 12)
- Number of participants with risk for depression after estriol use(baseline and week 12)
- Number of participants with risk for sexual dysfunction after estriol use(baseline and week 12)
- Reduction of de degree of coital pain(baseline and week 12)
- Variation in serum levels of estriol after estriol use(Assessment of serum concentration of estriol at baseline and week 12.)
- Variation in serum levels of follicle-stimulating hormone after estriol use(Assessment of serum concentration of follicle-stimulating hormone at baseline and week 12.)
- Variation in serum levels of thyroid-stimulating hormone after estriol use(Assessment of serum concentration of thyroid-stimulating hormone at baseline and week 12.)
- Number of participants with adverse events that are related to estriol use(Assessment of laboratory values at baseline and week 12. Adverse events assessed each 4 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.)
- Variation in blood glucose after estriol use(Assessed at baseline and on week 12)
- Variation in weight after estriol use Weight(Assessed at baseline and on week 12)
- Variation in body mass index (BMI) after estriol use(Assessed at baseline and on week 12)
研究者
Lucia Alves da Silva Lara
M.D, Ph.D. Gynecology & Obstetrics, Sexual Health.
University of Sao Paulo