A Phase II Study of Vaginal Testosterone Cream vs. the ESTRING for Vaginal Dryness or Decreased Libido in Early Breast Cancer Patients Treated With Aromatase Inhibitors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range
研究概览
简要总结
The purpose of this clinical research study is to determine whether the ESTRING or a special preparation of a testosterone cream inserted vaginally are safe for use in breast cancer patients. This study will also evaluate if either of these treatments can improve symptoms of vaginal dryness or decreased sexual interest that are related to your treatment for breast cancer.
详细描述
There is a growing body of scientific literature to suggest that sexual functioning is one of the most distressing problems experienced by breast cancer survivors. Vaginal dryness, dyspareunia (pain during sexual intercourse), and decreased libido are common complaints among breast cancer patients. With increasing use of aromatase inhibitors which are associated with a higher rate of vaginal dryness than tamoxifen, these problems are becoming even more prominent. This study will evaluate the safety and tolerability of the ESTRING and 1% testosterone cream administered vaginally as treatments for vaginal dryness and/or decreased libido in women receiving an aromatase inhibitor for early stage breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed Stage I-III breast cancer who are taking an aromatase inhibitor as adjuvant hormonal therapy. Patient must have started the aromatase inhibitor at least 60 days prior to enrolling.
- •Postmenopausal estradiol levels at baseline as measured by standard laboratory analysis.
- •Patient may be rendered postmenopausal through the use of a GnRH agonist, but must have confirmed post-menopausal levels of serum estradiol on two lab tests at least one month apart.
- •If patient has been rendered post-menopausal by adjuvant chemotherapy but has had a period within the past 12 months, post-menopausal levels of serum estradiol must be documented on two lab tests at least 3 months apart.
- •Age ≥18 and ≤80 years old.
- •Adequate hematologic, hepatic, and renal function as defined by:
- •Hgb ≥9 g/dL
- •Absolute neutrophil count (ANC)/absolute granulocyte count (AGC) ≥1500 cells/mm3
- •Platelet count ≥100,000/mm3
- •Serum creatinine ≤1.5 mg/dL
- •Total bilirubin ≤1.5 times the ULN; and aspartate aminotransferase ≤3 times the ULN
- •Normal thyroid function tested within the past 6 months (Patients with a diagnosis of hypothyroidism and on thyroid supplementation must have had thyroid function tests in the normal range within the past 3 months)
- •Patient must have recovered from the side effects of previous chemotherapy, surgery, or radiation therapy for early breast cancer.
排除标准
- •History of radiation to the vaginal area
- •Concurrent treatment with any type of oral, injectable or topical form of estrogen or androgen therapy including natural supplements marketed as hormone replacement products
- •Initiation of topical moisturizers (for example, Replens), or herbal or alternative medicines to manage the symptoms of vaginal dryness while on study. Patients who were previously using these products may continue them with the same usage pattern while on study.
- •Use of vaginal hormonal products (rings, inserts, creams, gels) containing estrogens or androgens within the past 30 days.
- •History of an abnormal pap smear within the last 12 months
- •History of endometrial or ovarian cancer
- •Any episode of vaginal bleeding in the past 6 months that has not been evaluated by a gynecological exam and/or pelvic ultrasound
- •History of sexual dysfunction prior to diagnosis of breast cancer ( Sexual dysfunction will be defined as loss of libido or inability to achieve orgasm for which patient sought medical attention or which patient felt significantly interfered with quality of life.)
- •Moderate or severe depression for which the patient is receiving ongoing psychological counseling and/or taking antidepressants, and for whom, in the investigators opinion may be interfering in the patients sexual function independent of the side effects of breast cancer and aromatase inhibitor use.
- •Use of any investigational agent for breast cancer within 3 weeks of study entry.
研究组 & 干预措施
Testosterone Cream
Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
干预措施: Testosterone Cream (Drug)
Estring
Estring 2mg ring inserted vaginally once every 12 weeks
干预措施: Estring (Drug)
结局指标
主要结局
Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range
时间窗: 12 Weeks
Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol \>10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was \>10 pg/dl, subsequent levels \>10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range.
次要结局
- Matched E2 by Commercial and Research (RIA) Analyses(baseline, 4 weeks)
- Total Testosterone Levels(12 weeks)
- Sexual Quality of Life(Baseline, Week 4, Week 12)
- Sexual Satisfaction(Baseline, Week 4, Week 12)
- Change in Vaginal Epithelium Scores(Baseline, 12 weeks)
- Serum Estradiol (E2)(12 weeks)