Phase 2 Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- satisfactory sexual events
研究概览
简要总结
Female sexual dysfunction (FSD) is an established side effect of Selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs), causing symptoms such as loss of libido, arousal difficulties, or delayed orgasm or anorgasmia.
Efficacy of testosterone therapy for the treatment of hypoactive sexual desire disorder (HSDD) in women has been demonstrated in studies including naturally and surgically menopausal women, either alone or in combination with estrogen, with or without progestin therapy.
详细描述
Recent studies have reported an increase in the number of satisfactory sexual events recorded in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress.
There is also evidence that testosterone therapy results in a similar improvement in sexual function in premenopausal women with loss of libido.
Testosterone therapy has been associated with significantly improved well-being in studies in which the participants had low well-being at enrollment.
Trials of testosterone for HSDD in women have excluded those with clinical depression, as well as those taking antidepressants.
Whether testosterone will benefit women with HSDD who are taking an antidepressant is not known.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •a body mass index between 18 and 35 kg/m2
- •diminished libido complaints
- •no evidence of severe clinical depression
- •participants in good health based on history and physical examination.
排除标准
- •a past history of neurological disorder
- •recent psychiatric or systemic illness
- •use of psychoactive medications
- •alcohol excess consumption or any other drug abuse.
- •women who had under gone treatment for cardiovascular disease, genital bleeding, acne, depression, dyspareunia or those who had received oral androgen therapy in the previous 3 months were excluded
- •in addition women taking medications known to interfere with sex steroid metabolism were also excluded.
研究组 & 干预措施
Biolipid B2 (blanked/placebo)
The study is a single-center, single-blind, placebo-controlled, parallel group trial.
It consists of a 4-week screening period plus a 12-week treatment phase. At the screening visit, all participants underwent a physical examination including vital signs and breast and pelvic examination.
They were randomly assigned in a 1:1 ratio to receive a transdermal vehicle biolipid B2 (identical placebo) provided by Evidence Pharmaceuticals Inc, SP,BRAZIL.
The testosterone and placebo emulsion were alcohol-free matrixes that were applied topically to the forearm daily for the period of 12 weeks.
干预措施: Biolipid B2 (blanked/placebo) (Drug)
Biolipid B2 (blanked/placebo)
The study is a single-center, single-blind, placebo-controlled, parallel group trial.
It consists of a 4-week screening period plus a 12-week treatment phase. At the screening visit, all participants underwent a physical examination including vital signs and breast and pelvic examination.
They were randomly assigned in a 1:1 ratio to receive a transdermal vehicle biolipid B2 (identical placebo) provided by Evidence Pharmaceuticals Inc, SP,BRAZIL.
The testosterone and placebo emulsion were alcohol-free matrixes that were applied topically to the forearm daily for the period of 12 weeks.
干预措施: Testosterone, Transdermal, Behavior (Drug)
Testosterone, Transdermal, Behavior
Testosterone 0.5%, daily, 3 months
干预措施: Biolipid B2 (blanked/placebo) (Drug)
Testosterone, Transdermal, Behavior
Testosterone 0.5%, daily, 3 months
干预措施: Testosterone, Transdermal, Behavior (Drug)
结局指标
主要结局
satisfactory sexual events
时间窗: 12 weeks
Recent studies have reported an increase in the number of satisfactory sexual events (SSEs) recorded in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress.
次要结局
- Total testosterone and SHBG levels at screening and after 12 weeks of treatment.(12 weeks)