Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function

Hypogonadism, Male Clinical Trial

— CAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03933618
• Other study ID #: 4134
• Status: Completed
• Phase: Phase 2
• Start date: April 2, 2015
• Est. completion date: March 8, 2017

Study information

• Verified date: October 2019
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 8, 2017
• Est. primary completion date: March 8, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadism, Male

Intervention

Drug:
• Anastrozole 1mg

• Clomiphene Citrate 25mg

• Placebo - Cap

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Albany Medical College	Laboratory Corporation of America

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At baseline
Primary	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	Week 8
Primary	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	Week 16
Primary	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	Week 24
Secondary	Normalized Testosterone - Screen	Normalized at >350ng/dl	Baseline
Secondary	Normalized Testosterone - Week 8	Normalized at >350ng/dl	Week 8
Secondary	Normalized Testosterone - Week 16	Normalized at >350ng/dl	Week 16
Secondary	Normalized Testosterone - Week 24	Normalized at >350ng/dl	Week 24
Secondary	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	Baseline
Secondary	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	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	Week 8
Secondary	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	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	Week 16
Secondary	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	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	Week 24
Secondary	EHS (Erectile Hardness Score) - Screen	Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid	Baseline
Secondary	EHS (Erectile Hardness Score) - Week 8	Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid	Week 8
Secondary	EHS (Erectile Hardness Score) - Week 16	Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid	Week 16
Secondary	EHS (Erectile Hardness Score) - Week 24	Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid	Week 24
Secondary	LH - Screen	Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.	Baseline
Secondary	LH - Week 8	Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.	Week 8
Secondary	LH - Week 16	Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.	Week 16
Secondary	LH - Week 24	Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.	Week 24
Secondary	FSH - Screen	Lab Values for follicle stimulating hormone	Baseline
Secondary	FSH - Week 8	Lab Values for follicle stimulating hormone	Week 8
Secondary	FSH - Week 16	Lab Values for follicle stimulating hormone	Week 16
Secondary	FSH - Week 24	Lab Values for follicle stimulating hormone	Week 24
Secondary	Free Testosterone - Screen	Measure of Free Testosterone	Baseline
Secondary	Free Testosterone - Week 8	Measure of Free Testosterone	Week 8
Secondary	Free Testosterone - Week 16	Measure of Free Testosterone	Week 16
Secondary	Free Testosterone - Week 24	Measure of Free Testosterone	Week 24
Secondary	Estradiol - Screen	Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24	Baseline
Secondary	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	Week 8
Secondary	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	Week 16
Secondary	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	Week 24
Secondary	SHBG - Screen	Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24	Baseline
Secondary	SHBG - Week 8	Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24	Week 8
Secondary	SHBG - Week 16	Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24	Week 16
Secondary	SHBG - Week 24	Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24	Week 24
Secondary	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	Baseline
Secondary	SEP #1-3 Cumulative - Week 8	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	Week 8
Secondary	SEP #1-3 Cumulative - Week 16	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	Week 16
Secondary	SEP #1-3 Cumulative - Week 24	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	Week 24