Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function

Albany Medical College24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hypogonadism, Male

Interventions

Anastrozole 1mgDRUG

Clomiphene Citrate 25mgDRUG

Placebo - CapDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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. -

Outcomes

Primary Outcomes

IIEF (International Index of Erectile Function) Score - Screen

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

Time frame: At baseline

IIEF (International Index of Erectile Function) Score - 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

Time frame: Week 8

IIEF (International Index of Erectile Function) Score - 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

Time frame: Week 16

IIEF (International Index of Erectile Function) Score - 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

Time frame: Week 24

Secondary Outcomes

Normalized Testosterone - Screen

Normalized at \>350ng/dl

Time frame: Baseline

Normalized Testosterone - Week 8

Normalized at \>350ng/dl

Time frame: Week 8

Normalized Testosterone - Week 16

Normalized at \>350ng/dl

Time frame: Week 16

Normalized Testosterone - Week 24

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Normalized at \>350ng/dl

ADAM (Androgen Deficiency in the Aging Male) Score - Screen

Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0

Time frame: Baseline

ADAM (Androgen Deficiency in the Aging Male) Score - Week 8

Time frame: Week 8

ADAM (Androgen Deficiency in the Aging Male) Score - Week 16

Time frame: Week 16

ADAM (Androgen Deficiency in the Aging Male) Score - Week 24

Time frame: Week 24

EHS (Erectile Hardness Score) - Screen

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

Time frame: Baseline

EHS (Erectile Hardness Score) - Week 8

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

Time frame: Week 8

EHS (Erectile Hardness Score) - Week 16

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

Time frame: Week 16

EHS (Erectile Hardness Score) - Week 24

Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid

Time frame: Week 24

LH - Screen

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

Time frame: Baseline

LH - Week 8

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

Time frame: Week 8

LH - Week 16

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

Time frame: Week 16

LH - Week 24

Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.

Time frame: Week 24

FSH - Screen

Lab Values for follicle stimulating hormone

Time frame: Baseline

FSH - Week 8

Lab Values for follicle stimulating hormone

Time frame: Week 8

FSH - Week 16

Lab Values for follicle stimulating hormone

Time frame: Week 16

FSH - Week 24

Lab Values for follicle stimulating hormone

Time frame: Week 24

Free Testosterone - Screen

Measure of Free Testosterone

Time frame: Baseline

Free Testosterone - Week 8

Measure of Free Testosterone

Time frame: Week 8

Free Testosterone - Week 16

Measure of Free Testosterone

Time frame: Week 16

Free Testosterone - Week 24

Measure of Free Testosterone

Time frame: Week 24

Estradiol - Screen

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24

Time frame: Baseline

Estradiol - Week 8

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was \<5

Time frame: Week 8

Estradiol - Week 16

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was \<5

Time frame: Week 16

Estradiol - Week 24

Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was \<5

Time frame: Week 24

SHBG - Screen

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

Time frame: Baseline

SHBG - Week 8

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

Time frame: Week 8

SHBG - Week 16

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

Time frame: Week 16

SHBG - Week 24

Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24

Time frame: Week 24

SEP #1-3 Cumulative - Screen

Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0

Time frame: Baseline

SEP #1-3 Cumulative - Week 8

Time frame: Week 8

SEP #1-3 Cumulative - Week 16

Time frame: Week 16

SEP #1-3 Cumulative - Week 24

Time frame: Week 24