2024-517315-69-00招募中3 期
Vaginal administration of selective estrogen receptor modulator (Tamoxifen) treatment to improve sexual function for women with breast cancer. A randomized, double-blinded, placebo controlled longitudinal phase 3 study.
Uppsala University3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年8月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- The primary endpoint will be captured by a modified version of the Endocrine Subscale-FACT-B, a validated 5-point response scale (not at all/minor/moderate/considerable/severe) developed for breast cancer research
研究概览
简要总结
The primary objective is to evaluate the efficacy of vaginal tamoxifen in reducing the most troublesome vulvovaginal atrophy symptom in women with breast cancer evaluated by use of Endocrine Subscale- FACT-B.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sexually active postmenopausal women with breast cancer and ongoing adjuvant antiestrogen treatment with aromatase inhibitors who are willing to participate in the study and give their written consent.
- •Postmenopausal women with at least 12 months of spontaneous amenorrhea, or women who have had surgical bilateral oophorectomy at least 6 weeks ago, or level of follicle stimulating hormone (FSH) > 40 mIU/mL.
- •Have a vaginal pH > 5.0 at screening.
- •Have ≤ 5% superficial cells in vaginal smear cytology at screening.
- •Have estradiol levels below the detection level, < 20 pmol/l.
- •Have one moderate to severe vulvovaginal atrophy symptom on the FACT-B scale that has been identified by the subject as being the most bothersome to her.
- •Be judged by the principal investigator as being in otherwise good health. The medical evaluation findings must include: a. A normal or clinically non-significant finding at physical examination. b. A mean sitting systolic blood pressure ≤150 mm Hg and diastolic blood pressure ≤90 mm Hg at screening. c. A normal or clinically non-significant finding at gynaecological examination. d. A normal mammography that has been performed within 36 months prior to initial dose of study medication. e. Laboratory values within normal limits or with non-significant deviations from normal values.
- •Have an endometrial thickness of < 4 mm as determined by vaginal ultrasonography, in women with an intact uterus.
排除标准
- •Postmenopausal women with breast cancer and ongoing adjuvant antiestrogen treatment with oral tamoxifen. In addition, women meeting any of the following criteria will not be permitted to enter the study:
- •Have a history of cardiovascular disease or thromboembolic events.
- •Have a history of or ongoing hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, neurologic, psychological, or musculoskeletal disease or disorder that is clinically significant in the opinion of the principal investigator.
- •Have a history of endometrial hyperplasia, endometrial polyps, endometrial cancer, or ovarian cancer.
- •Have a history of undiagnosed vaginal bleeding.
- •Have an ongoing urogenital infection in spite of treatment at the randomization visit.
- •Have used estrogen alone or estrogen/progestin for any of the following time periods: a. Vaginal hormonal products (rings, creams, gels, vaginal suppositories) within 12 weeks prior to the screening visit
结局指标
主要结局
The primary endpoint will be captured by a modified version of the Endocrine Subscale-FACT-B, a validated 5-point response scale (not at all/minor/moderate/considerable/severe) developed for breast cancer research
The primary endpoint will be captured by a modified version of the Endocrine Subscale-FACT-B, a validated 5-point response scale (not at all/minor/moderate/considerable/severe) developed for breast cancer research
次要结局
- Change from baseline to week 12 in all subscales of the modified version of the Endocrine Subscale-FACT-B. Change from baseline to week 12 in total score on the Female Sexual Function Index (FSFI). Change from baseline to week 12 in total score on the Female Sexual Distress Scale-revised (FSDS-R). Change from baseline to Week 12 in Quality of Life. Information will be collected using the EORTC QLQ-C30
研究者
Inger Sundström Poromaa
Scientific
Uppsala University
研究点 (3)
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