Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function (CAP)

Albany Medical College

Status and phase: Completed; Phase 2

Conditions: Hypogonadism, Male

Treatments: Drug: Anastrozole 1mg; Drug: Clomiphene Citrate 25mg; Drug: Placebo - Cap

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03933618

4134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 6 patient groups

anastrazole-clomiphene-placebo

Other group

Description:

anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks

Treatment:

Drug: Anastrozole 1mg

Drug: Placebo - Cap

Drug: Clomiphene Citrate 25mg

anastrazole-placebo-clomiphene

Other group

Description:

anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks

Treatment:

Drug: Anastrozole 1mg

Drug: Placebo - Cap

Drug: Clomiphene Citrate 25mg

clomiphene-anastrazole-placebo

Other group

Description:

clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks

Treatment:

Drug: Anastrozole 1mg

Drug: Placebo - Cap

Drug: Clomiphene Citrate 25mg

clomiphene-placebo-anastrazole

Other group

Description:

clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks

Treatment:

Drug: Anastrozole 1mg

Drug: Placebo - Cap

Drug: Clomiphene Citrate 25mg

placebo-clomiphene-anastrazole

Other group

Description:

placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks

Treatment:

Drug: Anastrozole 1mg

Drug: Placebo - Cap

Drug: Clomiphene Citrate 25mg

placebo-anastrazole-clomiphene

Other group

Description:

placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks

Treatment:

Drug: Anastrozole 1mg

Drug: Placebo - Cap

Drug: Clomiphene Citrate 25mg