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出境医 / 临床实验 / Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function (CAP)
Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function (CAP)
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypogonadism, Male | Drug: Anastrozole 1mg Drug: Clomiphene Citrate 25mg Drug: Placebo - Cap | Phase 2 |
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 24 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | April 2, 2015 |
| Actual Primary Completion Date : | March 8, 2017 |
| Actual Study Completion Date : | March 8, 2017 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
anastrazole-clomiphene-placebo
anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks
|
Drug: Anastrozole 1mg Drug: Clomiphene Citrate 25mg Drug: Placebo - Cap |
|
anastrazole-placebo-clomiphene
anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks
|
Drug: Anastrozole 1mg Drug: Clomiphene Citrate 25mg Drug: Placebo - Cap |
|
clomiphene-anastrazole-placebo
clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks
|
Drug: Anastrozole 1mg Drug: Clomiphene Citrate 25mg Drug: Placebo - Cap |
|
clomiphene-placebo-anastrazole
clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks
|
Drug: Anastrozole 1mg Drug: Clomiphene Citrate 25mg Drug: Placebo - Cap |
|
placebo-clomiphene-anastrazole
placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks
|
Drug: Anastrozole 1mg Drug: Clomiphene Citrate 25mg Drug: Placebo - Cap |
|
placebo-anastrazole-clomiphene
placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks
|
Drug: Anastrozole 1mg Drug: Clomiphene Citrate 25mg Drug: Placebo - Cap |
Outcome Measures
Primary Outcome Measures :
- 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
- 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
- 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
- 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 Outcome Measures :
- Normalized Testosterone - Screen [ Time Frame: Baseline ]Normalized at >350ng/dl
- Normalized Testosterone - Week 8 [ Time Frame: Week 8 ]Normalized at >350ng/dl
- Normalized Testosterone - Week 16 [ Time Frame: Week 16 ]Normalized at >350ng/dl
- Normalized Testosterone - Week 24 [ Time Frame: Week 24 ]Normalized at >350ng/dl
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- FSH - Screen [ Time Frame: Baseline ]Lab Values for follicle stimulating hormone
- FSH - Week 8 [ Time Frame: Week 8 ]Lab Values for follicle stimulating hormone
- FSH - Week 16 [ Time Frame: Week 16 ]Lab Values for follicle stimulating hormone
- FSH - Week 24 [ Time Frame: Week 24 ]Lab Values for follicle stimulating hormone
- Free Testosterone - Screen [ Time Frame: Baseline ]Measure of Free Testosterone
- Free Testosterone - Week 8 [ Time Frame: Week 8 ]Measure of Free Testosterone
- Free Testosterone - Week 16 [ Time Frame: Week 16 ]Measure of Free Testosterone
- Free Testosterone - Week 24 [ Time Frame: Week 24 ]Measure of Free Testosterone
- Estradiol - Screen [ Time Frame: Baseline ]Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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. -
Contacts and Locations
Sponsors and Collaborators
Albany Medical College
Laboratory Corporation of America
Investigators
| Principal Investigator: | Robert C Welliver, MD | Albany Medical College |
| Tracking Information | ||||
|---|---|---|---|---|
| First Submitted Date ICMJE | April 29, 2019 | |||
| First Posted Date ICMJE | May 1, 2019 | |||
| Results First Submitted Date ICMJE | July 15, 2019 | |||
| Results First Posted Date ICMJE | November 18, 2019 | |||
| Last Update Posted Date | November 18, 2019 | |||
| Actual Study Start Date ICMJE | April 2, 2015 | |||
| Actual Primary Completion Date | March 8, 2017 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE |
IIEF (International Index of Erectile Function) Score [ Time Frame: 4 weeks ] Self reported erectile function over the past 4 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
|
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| Change History | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||
| Original Other Pre-specified Outcome Measures | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function | |||
| Official Title ICMJE | 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 | |||
| 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. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Hypogonadism, Male | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE |
24 | |||
| Original Actual Enrollment ICMJE |
25 | |||
| Actual Study Completion Date ICMJE | March 8, 2017 | |||
| Actual Primary Completion Date | March 8, 2017 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT03933618 | |||
| Other Study ID Numbers ICMJE | 4134 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Albany Medical College | |||
| Study Sponsor ICMJE | Albany Medical College | |||
| Collaborators ICMJE | Laboratory Corporation of America | |||
| Investigators ICMJE |
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| PRS Account | Albany Medical College | |||
| Verification Date | October 2019 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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