Clinical trial NCT03933618: Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadism, Male
Lead sponsor: Albany Medical College
Sponsor class: OTHER
Collaborators: name: Laboratory Corporation of America
First posted: 2019-05-01
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Men age 18-70
2. Baseline morning Testosterone 150-350 ng/dL x2
3. leutenizing hormone (LH) 1.5-9.2 miU/mL, Follicle stimulation hormone (FSH) 1.6-8.0 miU/mL, Prolactin 4-15 ng/mL
4. 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
5. Body mass index (BMI) \<40
6. Sexual health inventory for men (SHIM) score \>7 and \<21. 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.
7. Men must attempt to have at least four sexual encounters over each of the eight-week periods
8. Men willing not to take phosphodiesterase 5 inhibitors throughout the entire study

Exclusion Criteria:

1. Current or previous history of prostate cancer
2. Previous or current androgen deprivation therapy for prostate cancer,
3. Past surgical history of prostatectomy.
4. History of testicular cancer.
5. History of deep vein thrombosis (DVT) or blood dyscrasia
6. History of breast cancer
7. 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.
8. Chronic opioid use
9. Use of steroids within the past 3 months, including prednisone and/or cortisone injections, and inhaled steroids. Topical steroid cream is acceptable.
10. 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
11. History of or current use of anti-androgen medications, i.e. Aldactone, Tagamet, estrogens
12. Alcohol intake \> 30 grams (drink more than 2 beers per day OR more than 1 glass of wine or cocktail daily)
13. Having started a new medication during the past three months which may interfere with the outcome measures of the study
14. Polycythemia (HCT \>52% )
15. History of prostate specific antigen (PSA)\> 4.0 ng/dl
16. Hematocrit (HCT)\< 36 %
17. 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.
18. Previous hypogonadal treatment within last 3 months. -

Primary outcomes:
measure: IIEF (International Index of Erectile Function) Score - Screen
timeFrame: At baseline
measure: IIEF (International Index of Erectile Function) Score - Week 8
timeFrame: Week 8
measure: IIEF (International Index of Erectile Function) Score - Week 16
timeFrame: Week 16
measure: IIEF (International Index of Erectile Function) Score - Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Normalized Testosterone - Screen
timeFrame: Baseline
measure: Normalized Testosterone - Week 8
timeFrame: Week 8
measure: Normalized Testosterone - Week 16
timeFrame: Week 16
measure: Normalized Testosterone - Week 24
timeFrame: Week 24
measure: ADAM (Androgen Deficiency in the Aging Male) Score - Screen
timeFrame: Baseline
measure: ADAM (Androgen Deficiency in the Aging Male) Score - Week 8
timeFrame: Week 8
measure: ADAM (Androgen Deficiency in the Aging Male) Score - Week 16
timeFrame: Week 16
measure: ADAM (Androgen Deficiency in the Aging Male) Score - Week 24
timeFrame: Week 24
measure: EHS (Erectile Hardness Score) - Screen
timeFrame: Baseline
measure: EHS (Erectile Hardness Score) - Week 8
timeFrame: Week 8
measure: EHS (Erectile Hardness Score) - Week 16
timeFrame: Week 16
measure: EHS (Erectile Hardness Score) - Week 24
timeFrame: Week 24
measure: LH - Screen
timeFrame: Baseline
measure: LH - Week 8
timeFrame: Week 8
measure: LH - Week 16
timeFrame: Week 16
measure: LH - Week 24
timeFrame: Week 24
measure: FSH - Screen
timeFrame: Baseline
measure: FSH - Week 8
timeFrame: Week 8
measure: FSH - Week 16
timeFrame: Week 16
measure: FSH - Week 24
timeFrame: Week 24
measure: Free Testosterone - Screen
timeFrame: Baseline
measure: Free Testosterone - Week 8
timeFrame: Week 8
measure: Free Testosterone - Week 16
timeFrame: Week 16
measure: Free Testosterone - Week 24
timeFrame: Week 24
measure: Estradiol - Screen
timeFrame: Baseline
measure: Estradiol - Week 8
timeFrame: Week 8
measure: Estradiol - Week 16
timeFrame: Week 16
measure: Estradiol - Week 24
timeFrame: Week 24
measure: SHBG - Screen
timeFrame: Baseline
measure: SHBG - Week 8
timeFrame: Week 8
measure: SHBG - Week 16
timeFrame: Week 16
measure: SHBG - Week 24
timeFrame: Week 24
measure: SEP #1-3 Cumulative - Screen
timeFrame: Baseline
measure: SEP #1-3 Cumulative - Week 8
timeFrame: Week 8
measure: SEP #1-3 Cumulative - Week 16
timeFrame: Week 16
measure: SEP #1-3 Cumulative - Week 24
timeFrame: Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Albany Medical College
name: Robert C Welliver, MD
role: PRINCIPAL_INVESTIGATOR
References: