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Completed

NCT Number: NCT03933618

Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function

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.

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Key information

Conditions

Hypogonadism, Male Endocrine System Diseases Eunuchism Gonadal Disorders Hypogonadism

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 <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.
  • 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

Exclusion criteria

  • 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. -

Treatment and study plan

Anastrozole 1mg

Drug

Clomiphene Citrate 25mg

Drug

Placebo - Cap

Drug

Primary outcomes

  1. IIEF (International Index of Erectile Function) Score - Screen

    Time frame: 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

  2. IIEF (International Index of Erectile Function) Score - Week 8

    Time frame: 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

  3. IIEF (International Index of Erectile Function) Score - Week 16

    Time frame: 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

  4. IIEF (International Index of Erectile Function) Score - Week 24

    Time frame: 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

Secondary outcomes

  1. Normalized Testosterone - Screen

    Time frame: Baseline

    Normalized at >350ng/dl

  2. Normalized Testosterone - Week 8

    Time frame: Week 8

    Normalized at >350ng/dl

  3. Normalized Testosterone - Week 16

    Time frame: Week 16

    Normalized at >350ng/dl

  4. Normalized Testosterone - Week 24

    Time frame: Week 24

    Normalized at >350ng/dl

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

    Time frame: Baseline

    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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

  9. EHS (Erectile Hardness Score) - Screen

    Time frame: Baseline

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

  10. EHS (Erectile Hardness Score) - Week 8

    Time frame: Week 8

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

  11. EHS (Erectile Hardness Score) - Week 16

    Time frame: Week 16

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

  12. EHS (Erectile Hardness Score) - Week 24

    Time frame: Week 24

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

  13. LH - Screen

    Time frame: Baseline

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

  14. LH - Week 8

    Time frame: Week 8

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

  15. LH - Week 16

    Time frame: Week 16

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

  16. LH - Week 24

    Time frame: Week 24

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

  17. FSH - Screen

    Time frame: Baseline

    Lab Values for follicle stimulating hormone

  18. FSH - Week 8

    Time frame: Week 8

    Lab Values for follicle stimulating hormone

  19. FSH - Week 16

    Time frame: Week 16

    Lab Values for follicle stimulating hormone

  20. FSH - Week 24

    Time frame: Week 24

    Lab Values for follicle stimulating hormone

  21. Free Testosterone - Screen

    Time frame: Baseline

    Measure of Free Testosterone

  22. Free Testosterone - Week 8

    Time frame: Week 8

    Measure of Free Testosterone

  23. Free Testosterone - Week 16

    Time frame: Week 16

    Measure of Free Testosterone

  24. Free Testosterone - Week 24

    Time frame: Week 24

    Measure of Free Testosterone

  25. Estradiol - Screen

    Time frame: Baseline

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

  26. Estradiol - Week 8

    Time frame: 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

  27. Estradiol - Week 16

    Time frame: 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

  28. Estradiol - Week 24

    Time frame: 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

  29. SHBG - Screen

    Time frame: Baseline

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

  30. SHBG - Week 8

    Time frame: Week 8

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

  31. SHBG - Week 16

    Time frame: Week 16

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

  32. SHBG - Week 24

    Time frame: Week 24

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

  33. SEP #1-3 Cumulative - Screen

    Time frame: Baseline

    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

  34. SEP #1-3 Cumulative - Week 8

    Time frame: 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

  35. SEP #1-3 Cumulative - Week 16

    Time frame: 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

  36. SEP #1-3 Cumulative - Week 24

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Collaborators

  • Laboratory Corporation of America

Registry information

Official study 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

Acronym: CAP

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 1, 2019
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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