A Randomized, Double-Blind, Placebo-controlled, Parallel-group, 52-week Study to Evaluate the Efficacy/Safety of Transdermal Patches Delivering Testosterone in Menopausal Women With Low Libido Not Receiving Estrogen Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 814
- 试验地点
- 1
- 主要终点
- Total satisfying sexual activity over 24 weeks
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy.
详细描述
Detailed Description:
Hypoactive sexual desire disorder (HSDD) is a condition suffered by as many as 32% of the menopausal population. It is generally defined as a low libido which causes distress. Testosterone therapy (transdermal patch) is currently under investigation for this disorder and results of three phase 3 trials have shown evidence of efficacy in menopausal patients on hormone replacement therapy. Low libido does not discriminate between those women utilizing hormone replacement therapy and those who do not. This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy. Persons could elect to go into a single blind study for one year after completing the first yeat double blind
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be a generally healthy surgically menopausal woman (12 months), 20 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy
- •Be a generally healthy naturally menopausal woman (2 years since last period), 40 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy.
- •Be, in their own judgment, in a stable monogamous sexual relationship for at least one year prior to study entry that is perceived to be secure and communicative with the same partner who is sexually functional and physically present at least 50% of the time.
- •Answer affirmatively to ALL of the following questions:
- •Was the patient's sex life before menopause good and satisfying in general?
- •Since menopause, has a meaningful loss in the level of desire for sex occurred?
- •Since menopause, has a significant decrease in sexual activity occurred?
- •Is the current level of desire for or interest in sex bothering or concerning?
- •Is an increase in the level of interest in or desire for sex and sexual activity desired?
排除标准
- •Physical limitations that would interfere with normal sexual function;
- •Estrogen use in the last 12 weeks (vaginal estriol or low dose vaginal estradiol accepted)
- •Use of any of the following medications:
- •antiandrogen therapy or topical minoxidil (last 5 years),
- •androgen therapy (past 3 months/implantable past 7 months),
- •systemic corticosteroids,
- •selective serotonin reuptake inhibitors (SSRIs),
- •tricyclic anti-depressants,
- •anti-androgens,
- •systemic beta-blockers,
- •anti-adrenergics,
- •spironolactone,
- •apomorphine,
- •phosphodiesterase type 5 (PDE5) inhibitors (e.g., Viagra, tibolone or selective estrogen receptor modulators (SERMs), including tamoxifen (last 12 weeks))
- •Be experiencing any chronic or acute life stress relating to any major life change that may significantly interfere with sexual function;
- •Have significant psychiatric disorder (including mild depressive disorder - Beck Depression Inventory-II score of > 14;
- •Have current severe dermatological problems or a known suspected hypersensitivity or allergy to any adhesive or any of the constituents of the transdermal testosterone patch
- •Have evidence of or history of malignancy (estrogen dependent or any gynecological cancer) within the last 5 years;
- •Have diabetes mellitus, active gallbladder disease, unstable thyroid disease, history of cerebrovascular disease, thrombo-embolic disorders, myocardial infarction or angina within the last 5 years or other significant organic disease that would prevent the patient from completing the study, or otherwise affect the outcome of the study.
- •Have significant abnormal pretreatment laboratory parameters.
研究组 & 干预措施
1
Placebo patch
干预措施: Placebo patch (Drug)
2
Testosterone patch (300mcg/day, changed twice a week for one year
干预措施: Testosterone (transdermal patches) (Drug)
结局指标
主要结局
Total satisfying sexual activity over 24 weeks
时间窗: 6, 12, 24, 36, and 52 weeks
次要结局
- Sexual desire(6, 12, 24, 36, and 52 weeks)
- personal distress(6, 12, 24, 36, and 52 weeks)
- other domains of the Profile of Female Sexual Function over 24 weeks(6, 12, 24, 36, and 52 weeks)
- mood, energy and well-being(6, 12, 24, 36, and 52 weeks)
- menopausal symptoms(6, 12, 24, 36, and 52 weeks)