NCT00612742已完成3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,656
- 试验地点
- 149
- 主要终点
- The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects.
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal female subjects
- •at least 50 years of age
- •with at least two points of cardiovascular risk
- •with a clinical diagnosis of HSDD.
排除标准
- •Subjects must not
- •require treatment with anti-androgens, high-dose oral or injectable corticosteroids, tamoxifen or other selective estrogen receptor modulators,
- •have used androgen therapy within 2 months of randomization,
- •have a history of estrogen-dependent neoplasia or any gynecologic cancer,
- •have a history of cancer of any kind in the past 10 years prior to randomization,
- •have a history of malignant melanoma or a history of invasive cancer at any time,
- •have a screening mammogram with any finding that requires follow up within 6 months of randomization,
- •have a history of myocardial infarction, coronary revascularization or stroke within 12 months of randomization,
- •have any medical condition associated with predicted survival of less than 3 years in the judgment of the Investigator.
研究组 & 干预措施
testosterone gel
Experimental
1% testosterone transdermal gel
干预措施: testosterone gel (Drug)
placebo gel
Placebo Comparator
placebo transdermal gel
干预措施: placebo gel (Drug)
结局指标
主要结局
The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects.
时间窗: 2011 primary outcome analysis for NDA submission
次要结局
未报告次要终点
研究者
研究点 (149)
Loading locations...
相似试验
已完成
3 期
A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced MelanomaMelanomaNCT02908672Hoffmann-La Roche514
已完成
3 期
A Study of Carboplatin Plus Etoposide With or Without ZKAB001 (Anti-PD-L1 Antibody) in Patients With ES-SCLCExtensive-stage Small-cell Lung CancerNCT04878016Lee's Pharmaceutical Limited498
招募中
3 期
Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AMLRelapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating MutationsNCT03250338Arog Pharmaceuticals, Inc.322
终止
3 期
Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial FibrillationParoxysmal Atrial FibrillationNCT05039359InCarda Therapeutics, Inc.54
终止
3 期
A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 SubjectsCovid19NCT05009732Suzhou Kintor Pharmaceutical Inc,139