A Randomized Double Blinded Placebo Controlled Trial Between Anastrozole and Clomiphene to Evaluate Improvement in Hypogonadal Symptoms and Erectile Function Using ADAM, IIEF and EHS Validated Scales
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- IIEF (International Index of Erectile Function) Score - Screen
研究概览
简要总结
This study evaluates anastrazole and clomiphene in the improvement in hypogonadal symptoms and erectile function. Each subject will receive Anastrazole 1 mg/day, clomiphene 25 mg/day and placebo in randomized schedule of 8 week intervals.
详细描述
Aromatase inhibitors (AI) (Anastrazole) and selective estrogen receptor modifiers (SERMS)(clomiphene) increase testosterone production through stimulation of the hypothalamic pituitary axis. While these drugs both reduce the feedback inhibition of estrogen on the pituitary, SERMs cause an increase in serum estradiol, whereas AIs reduce estradiol levels. Using these medications, we can obtain therapeutic testosterone levels with either an increase or decrease in estradiol levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men age 18-70
- •Baseline morning Testosterone 150-350 ng/dL x2
- •leutenizing hormone (LH) 1.5-9.2 miU/mL, Follicle stimulation hormone (FSH) 1.6-8.0 miU/mL, Prolactin 4-15 ng/mL
- •Positive Androgen Deficiency in the Aging Male (ADAM) score. A positive score is when an affirmative answer (''yes'') to either questions "Do you have a decreased sex drive/libido?" or "Are your erections less strong?" or any three other questions.10
- •Body mass index (BMI) <40
- •Sexual health inventory for men (SHIM) score >7 and <
- •Patients are allowed to be taking phosphodiesterase 5 inhibitors (i.e. Viagra, Levitra, Cialis) at baseline, however we will ask them to do the SHIM survey as if they were not taking this medication.
- •Men must attempt to have at least four sexual encounters over each of the eight-week periods
- •Men willing not to take phosphodiesterase 5 inhibitors throughout the entire study
排除标准
- •Current or previous history of prostate cancer
- •Previous or current androgen deprivation therapy for prostate cancer,
- •Past surgical history of prostatectomy.
- •History of testicular cancer.
- •History of deep vein thrombosis (DVT) or blood dyscrasia
- •History of breast cancer
- •Men with past or current treatment for erectile dysfunction including MUSE (alprostodil), intracavernosal injections, penile prosthesis. Men not on treatment or men who are on phosphodiesterase inhibitors will be allowed to be in the study but must stop their use at the screening visit.
- •Chronic opioid use
- •Use of steroids within the past 3 months, including prednisone and/or cortisone injections, and inhaled steroids. Topical steroid cream is acceptable.
- •History of or current use of anabolic steroids, i.e. testosterone, (or any analog of testosterone) dihydroepiandrosterone (DHEA), dihydroepiandrosterone sulfate (DHEAS) or any growth promoters i.e. growth hormone itself or analogs of growth hormone
- •History of or current use of anti-androgen medications, i.e. Aldactone, Tagamet, estrogens
- •Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of wine or cocktail daily)
- •Having started a new medication during the past three months which may interfere with the outcome measures of the study
- •Polycythemia (HCT >52% )
- •History of prostate specific antigen (PSA)> 4.0 ng/dl
- •Hematocrit (HCT)< 36 %
- •Liver function tests greater than 2 times upper normal limits or history of abnormal electrolytes, calcium or Parathyroid hormone without workup, at the discretion of the investigator.
- •Previous hypogonadal treatment within last 3 months. -
研究组 & 干预措施
anastrazole-clomiphene-placebo
anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks
干预措施: Anastrozole 1mg (Drug)
anastrazole-clomiphene-placebo
anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks
干预措施: Clomiphene Citrate 25mg (Drug)
clomiphene-placebo-anastrazole
clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks
干预措施: Anastrozole 1mg (Drug)
anastrazole-clomiphene-placebo
anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks
干预措施: Placebo - Cap (Drug)
anastrazole-placebo-clomiphene
anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks
干预措施: Anastrozole 1mg (Drug)
anastrazole-placebo-clomiphene
anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks
干预措施: Clomiphene Citrate 25mg (Drug)
anastrazole-placebo-clomiphene
anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks
干预措施: Placebo - Cap (Drug)
clomiphene-anastrazole-placebo
clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks
干预措施: Anastrozole 1mg (Drug)
clomiphene-anastrazole-placebo
clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks
干预措施: Clomiphene Citrate 25mg (Drug)
clomiphene-anastrazole-placebo
clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks
干预措施: Placebo - Cap (Drug)
clomiphene-placebo-anastrazole
clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks
干预措施: Clomiphene Citrate 25mg (Drug)
clomiphene-placebo-anastrazole
clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks
干预措施: Placebo - Cap (Drug)
placebo-clomiphene-anastrazole
placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks
干预措施: Anastrozole 1mg (Drug)
placebo-clomiphene-anastrazole
placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks
干预措施: Clomiphene Citrate 25mg (Drug)
placebo-clomiphene-anastrazole
placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks
干预措施: Placebo - Cap (Drug)
placebo-anastrazole-clomiphene
placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks
干预措施: Anastrozole 1mg (Drug)
placebo-anastrazole-clomiphene
placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks
干预措施: Clomiphene Citrate 25mg (Drug)
placebo-anastrazole-clomiphene
placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks
干预措施: Placebo - Cap (Drug)
结局指标
主要结局
IIEF (International Index of Erectile Function) Score - Screen
时间窗: At baseline
15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
IIEF (International Index of Erectile Function) Score - Week 8
时间窗: Week 8
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
IIEF (International Index of Erectile Function) Score - Week 16
时间窗: Week 16
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
IIEF (International Index of Erectile Function) Score - Week 24
时间窗: Week 24
15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
次要结局
- ADAM (Androgen Deficiency in the Aging Male) Score - Week 8(Week 8)
- EHS (Erectile Hardness Score) - Screen(Baseline)
- FSH - Week 16(Week 16)
- FSH - Week 24(Week 24)
- Free Testosterone - Screen(Baseline)
- FSH - Screen(Baseline)
- Free Testosterone - Week 8(Week 8)
- EHS (Erectile Hardness Score) - Week 8(Week 8)
- EHS (Erectile Hardness Score) - Week 16(Week 16)
- LH - Week 16(Week 16)
- FSH - Week 8(Week 8)
- Free Testosterone - Week 24(Week 24)
- Free Testosterone - Week 16(Week 16)
- Estradiol - Screen(Baseline)
- Estradiol - Week 24(Week 24)
- Estradiol - Week 16(Week 16)
- SHBG - Screen(Baseline)
- SHBG - Week 8(Week 8)
- Estradiol - Week 8(Week 8)
- SHBG - Week 16(Week 16)
- SHBG - Week 24(Week 24)
- SEP #1-3 Cumulative - Screen(Baseline)
- SEP #1-3 Cumulative - Week 8(Week 8)
- SEP #1-3 Cumulative - Week 16(Week 16)
- SEP #1-3 Cumulative - Week 24(Week 24)
- Normalized Testosterone - Screen(Baseline)
- ADAM (Androgen Deficiency in the Aging Male) Score - Screen(Baseline)
- ADAM (Androgen Deficiency in the Aging Male) Score - Week 16(Week 16)
- ADAM (Androgen Deficiency in the Aging Male) Score - Week 24(Week 24)
- EHS (Erectile Hardness Score) - Week 24(Week 24)
- LH - Screen(Baseline)
- LH - Week 8(Week 8)
- LH - Week 24(Week 24)
- Normalized Testosterone - Week 8(Week 8)
- Normalized Testosterone - Week 16(Week 16)
- Normalized Testosterone - Week 24(Week 24)