Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03933618

Acronym

CAP

Enrollment

Registered

2019-05-01

Start date

2015-04-02

Completion date

2017-03-08

Last updated

2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism, Male

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.

Interventions

DRUGAnastrozole 1mg

DRUGClomiphene Citrate 25mg

DRUGPlacebo - Cap

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

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. -

Design outcomes

Primary

Measure	Time frame	Description
IIEF (International Index of Erectile Function) Score - Screen	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	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	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	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

Measure	Time frame	Description
Estradiol - Week 24	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
Free Testosterone - Week 8	Week 8	Measure of Free Testosterone
Free Testosterone - Week 16	Week 16	Measure of Free Testosterone
Normalized Testosterone - Screen	Baseline	Normalized at \>350ng/dl
Normalized Testosterone - Week 8	Week 8	Normalized at \>350ng/dl
Normalized Testosterone - Week 16	Week 16	Normalized at \>350ng/dl
Normalized Testosterone - Week 24	Week 24	Normalized at \>350ng/dl
ADAM (Androgen Deficiency in the Aging Male) Score - Screen	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	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	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	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	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	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	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	Week 24	Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
LH - Screen	Baseline	Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
Free Testosterone - Week 24	Week 24	Measure of Free Testosterone
LH - Week 16	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	Week 24	Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
FSH - Screen	Baseline	Lab Values for follicle stimulating hormone
FSH - Week 8	Week 8	Lab Values for follicle stimulating hormone
FSH - Week 16	Week 16	Lab Values for follicle stimulating hormone
FSH - Week 24	Week 24	Lab Values for follicle stimulating hormone
Free Testosterone - Screen	Baseline	Measure of Free Testosterone
SHBG - Screen	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	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	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	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	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	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	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	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
LH - Week 8	Week 8	Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
Estradiol - Screen	Baseline	Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24
Estradiol - Week 8	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	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

Participant flow

Recruitment details

Men will be incentivized to come to each clinic appointment with $20 dollars at the end. If they complete the study they will be able to earn $100. Men will be incentivized to not use phosphodiesterase inhibitors throughout the study by giving them three 100mg tablets of Viagra per month of the study for a total of twelve 100 mg tablets.

Participants by arm

Arm	Count
Anastrazole-clomiphene-placebo anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	4
Anastrazole-placebo-clomiphene anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	4
Clomiphene-anastrazole-placebo clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	4
Clomiphene-placebo-anastrazole clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	4
Placebo-clomiphene-anastrazole placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	4
Placebo-anastrazole-clomiphene placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap	4
Total	24

Baseline characteristics

Characteristic	Anastrazole-clomiphene-placebo	Anastrazole-placebo-clomiphene	Clomiphene-anastrazole-placebo	Clomiphene-placebo-anastrazole	Placebo-clomiphene-anastrazole	Placebo-anastrazole-clomiphene	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	4 Participants	4 Participants	4 Participants	4 Participants	4 Participants	4 Participants	24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants	4 Participants	4 Participants	3 Participants	4 Participants	4 Participants	23 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Region of Enrollment United States	4 participants	4 participants	4 participants	4 participants	4 participants	4 participants	4 participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	4 Participants	4 Participants	4 Participants	4 Participants	4 Participants	4 Participants	24 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 4	0 / 4	0 / 4	0 / 4	0 / 4	0 / 4
other Total, other adverse events	2 / 4	1 / 4	1 / 4	1 / 4	1 / 4	3 / 4
serious Total, serious adverse events	0 / 4	0 / 4	0 / 4	0 / 4	1 / 4	0 / 4

Outcome results

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

Time frame: At baseline

Population: Total IIEF reported at the initial encounter.

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Screen	Patients 1-6	34 score on a scale
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Screen	Patients 7-12	57 score on a scale
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Screen	Patients 13-18	55 score on a scale
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Screen	Patients 19-24	50 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Screen	Patients 19-24	52 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Screen	Patients 13-18	46 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Screen	Patients 1-6	43 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Screen	Patients 7-12	57 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Screen	Patients 13-18	41 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Screen	Patients 7-12	45 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Screen	Patients 1-6	57 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Screen	Patients 19-24	55 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Screen	Patients 7-12	32 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Screen	Patients 1-6	41 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Screen	Patients 13-18	45 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Screen	Patients 19-24	47 score on a scale
Placebo-clomiphene-anastrazole	IIEF (International Index of Erectile Function) Score - Screen	Patients 19-24	18 score on a scale
Placebo-clomiphene-anastrazole	IIEF (International Index of Erectile Function) Score - Screen	Patients 7-12	36 score on a scale
Placebo-clomiphene-anastrazole	IIEF (International Index of Erectile Function) Score - Screen	Patients 1-6	57 score on a scale
Placebo-clomiphene-anastrazole	IIEF (International Index of Erectile Function) Score - Screen	Patients 13-18	58 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Screen	Patients 7-12	55 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Screen	Patients 13-18	32 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Screen	Patients 19-24	62 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Screen	Patients 1-6	24 score on a scale

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

Time frame: Week 16

Population: Total IIEF reported at the end of the second 8 week period - at week 16~Data for patient 23 was not collected in the placebo-clomiphene-anastrazole arm.

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Week 16	Patients 7-12	43 score on a scale
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Week 16	Patients 19-24	62 score on a scale
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Week 16	Patients 13-18	53 score on a scale
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Week 16	Patients 1-6	45 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Week 16	Patients 19-24	38 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Week 16	Patients 1-6	53 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Week 16	Patients 7-12	56 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Week 16	Patients 13-18	62 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Week 16	Patients 7-12	50 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Week 16	Patients 1-6	35 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Week 16	Patients 19-24	51 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Week 16	Patients 13-18	37 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Week 16	Patients 13-18	58 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Week 16	Patients 1-6	45 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Week 16	Patients 19-24	47 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Week 16	Patients 7-12	55 score on a scale
Placebo-clomiphene-anastrazole	IIEF (International Index of Erectile Function) Score - Week 16	Patients 1-6	66 score on a scale
Placebo-clomiphene-anastrazole	IIEF (International Index of Erectile Function) Score - Week 16	Patients 13-18	59 score on a scale
Placebo-clomiphene-anastrazole	IIEF (International Index of Erectile Function) Score - Week 16	Patients 7-12	33 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Week 16	Patients 19-24	18 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Week 16	Patients 1-6	37 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Week 16	Patients 7-12	38 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Week 16	Patients 13-18	15 score on a scale

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

Time frame: Week 24

Population: Total IIEF reported at the end of the final 8 week period - at week 24~Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Week 24	Patients 7-12	54 score on a scale
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Week 24	Patients 19-24	52 score on a scale
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Week 24	Patients 13-18	60 score on a scale
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Week 24	Patients 1-6	12 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Week 24	Patients 19-24	59 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Week 24	Patients 1-6	70 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Week 24	Patients 7-12	60 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Week 24	Patients 13-18	65 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Week 24	Patients 7-12	43 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Week 24	Patients 1-6	42 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Week 24	Patients 19-24	60 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Week 24	Patients 13-18	72 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Week 24	Patients 19-24	47 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Week 24	Patients 1-6	52 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Week 24	Patients 7-12	35 score on a scale
Placebo-clomiphene-anastrazole	IIEF (International Index of Erectile Function) Score - Week 24	Patients 13-18	45 score on a scale
Placebo-clomiphene-anastrazole	IIEF (International Index of Erectile Function) Score - Week 24	Patients 7-12	27 score on a scale
Placebo-clomiphene-anastrazole	IIEF (International Index of Erectile Function) Score - Week 24	Patients 1-6	65 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Week 24	Patients 19-24	14 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Week 24	Patients 1-6	41 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Week 24	Patients 7-12	45 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Week 24	Patients 13-18	17 score on a scale

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

Time frame: Week 8

Population: Total IIEF reported at the end of the first 8 week period

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Week 8	Patients 1-6	25 score on a scale
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Week 8	Patients 7-12	45 score on a scale
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Week 8	Patients 13-18	55 score on a scale
Anastrazole-clomiphene-placebo	IIEF (International Index of Erectile Function) Score - Week 8	Patients 19-24	63 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Week 8	Patients 13-18	59 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Week 8	Patients 7-12	51 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Week 8	Patients 1-6	55 score on a scale
Anastrazole-placebo-clomiphene	IIEF (International Index of Erectile Function) Score - Week 8	Patients 19-24	65 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Week 8	Patients 19-24	70 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Week 8	Patients 13-18	32 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Week 8	Patients 7-12	63 score on a scale
Clomiphene-anastrazole-placebo	IIEF (International Index of Erectile Function) Score - Week 8	Patients 1-6	32 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Week 8	Patients 1-6	20 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Week 8	Patients 19-24	45 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Week 8	Patients 7-12	45 score on a scale
Clomiphene-placebo-anastrazole	IIEF (International Index of Erectile Function) Score - Week 8	Patients 13-18	65 score on a scale
Placebo-clomiphene-anastrazole	IIEF (International Index of Erectile Function) Score - Week 8	Patients 13-18	43 score on a scale
Placebo-clomiphene-anastrazole	IIEF (International Index of Erectile Function) Score - Week 8	Patients 19-24	25 score on a scale
Placebo-clomiphene-anastrazole	IIEF (International Index of Erectile Function) Score - Week 8	Patients 7-12	72 score on a scale
Placebo-clomiphene-anastrazole	IIEF (International Index of Erectile Function) Score - Week 8	Patients 1-6	66 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Week 8	Patients 7-12	37 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Week 8	Patients 13-18	28 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Week 8	Patients 19-24	53 score on a scale
Placebo-anastrazole-clomiphene	IIEF (International Index of Erectile Function) Score - Week 8	Patients 1-6	35 score on a scale

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

Time frame: Baseline

Population: Initial Evaluation for ADAM score - Week 0

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 1-6	1 score on a scale
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 7-12	1 score on a scale
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 13-18	1 score on a scale
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 19-24	1 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 13-18	1 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 7-12	1 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 1-6	1 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 19-24	1 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 19-24	1 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 13-18	1 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 7-12	1 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 1-6	1 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 1-6	1 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 19-24	1 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 7-12	1 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 13-18	1 score on a scale
Placebo-clomiphene-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 13-18	1 score on a scale
Placebo-clomiphene-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 19-24	1 score on a scale
Placebo-clomiphene-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 7-12	1 score on a scale
Placebo-clomiphene-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 1-6	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 7-12	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 13-18	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 19-24	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Screen	Patients 1-6	1 score on a scale

Secondary

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

Time frame: Week 16

Population: ADAM score at the end of Week 16 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 7-12	1 score on a scale
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 19-24	1 score on a scale
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 13-18	1 score on a scale
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 1-6	1 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 19-24	1 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 1-6	1 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 7-12	1 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 13-18	1 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 7-12	1 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 1-6	1 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 19-24	1 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 13-18	1 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 13-18	0 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 1-6	1 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 19-24	1 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 7-12	1 score on a scale
Placebo-clomiphene-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 1-6	0 score on a scale
Placebo-clomiphene-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 13-18	0 score on a scale
Placebo-clomiphene-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 7-12	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 19-24	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 1-6	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 7-12	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 16	Patients 13-18	1 score on a scale

Secondary

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

Time frame: Week 24

Population: ADAM score at the end of Week 24 No data collected pt 15 in clomiphene-anastrazole-placebo arm no data collected for pt 16 clomiphene-placebo-anastrazole arm no data collected for pt 23 placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 19-24	1 score on a scale
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 1-6	1 score on a scale
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 7-12	1 score on a scale
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 13-18	0 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 13-18	0 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 19-24	1 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 1-6	0 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 7-12	1 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 7-12	1 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 19-24	1 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 1-6	0 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 7-12	1 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 19-24	0 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 1-6	1 score on a scale
Placebo-clomiphene-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 7-12	1 score on a scale
Placebo-clomiphene-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 1-6	0 score on a scale
Placebo-clomiphene-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 13-18	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 13-18	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 7-12	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 1-6	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 24	Patients 19-24	1 score on a scale

Secondary

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

Time frame: Week 8

Population: ADAM score at the end of Week 8~Data was not collected for patient 19 in anastrazole-clomiphene-placebo arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 1-6	1 score on a scale
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 13-18	1 score on a scale
Anastrazole-clomiphene-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 7-12	1 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 7-12	1 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 1-6	1 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 19-24	1 score on a scale
Anastrazole-placebo-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 13-18	0 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 19-24	1 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 7-12	0 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 1-6	1 score on a scale
Clomiphene-anastrazole-placebo	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 13-18	1 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 1-6	1 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 19-24	1 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 13-18	0 score on a scale
Clomiphene-placebo-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 7-12	1 score on a scale
Placebo-clomiphene-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 7-12	0 score on a scale
Placebo-clomiphene-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 1-6	1 score on a scale
Placebo-clomiphene-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 19-24	1 score on a scale
Placebo-clomiphene-anastrazole	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 13-18	0 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 19-24	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 1-6	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 7-12	1 score on a scale
Placebo-anastrazole-clomiphene	ADAM (Androgen Deficiency in the Aging Male) Score - Week 8	Patients 13-18	1 score on a scale

Secondary

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

Population: Score 0-4 at the initial encounter week 0

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Screen	Patients 13-18	3 score on a scale
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Screen	Patients 19-24	3 score on a scale
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Screen	Patients 1-6	3 score on a scale
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Screen	Patients 7-12	3 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Screen	Patients 19-24	3 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Screen	Patients 1-6	3 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Screen	Patients 7-12	3 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Screen	Patients 13-18	3 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Screen	Patients 7-12	3 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Screen	Patients 1-6	3 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Screen	Patients 13-18	3 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Screen	Patients 19-24	3 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Screen	Patients 19-24	3 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Screen	Patients 1-6	2 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Screen	Patients 7-12	2 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Screen	Patients 13-18	2 score on a scale
Placebo-clomiphene-anastrazole	EHS (Erectile Hardness Score) - Screen	Patients 1-6	3 score on a scale
Placebo-clomiphene-anastrazole	EHS (Erectile Hardness Score) - Screen	Patients 19-24	3 score on a scale
Placebo-clomiphene-anastrazole	EHS (Erectile Hardness Score) - Screen	Patients 13-18	1 score on a scale
Placebo-clomiphene-anastrazole	EHS (Erectile Hardness Score) - Screen	Patients 7-12	3 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Screen	Patients 19-24	3 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Screen	Patients 1-6	3 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Screen	Patients 7-12	3 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Screen	Patients 13-18	3 score on a scale

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

Time frame: Week 16

Population: Score 0-4 at the end of Week 16~Data for patient 23 was not collected in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Week 16	Patients 7-12	3 score on a scale
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Week 16	Patients 19-24	3 score on a scale
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Week 16	Patients 13-18	3 score on a scale
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Week 16	Patients 1-6	3 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Week 16	Patients 19-24	1 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Week 16	Patients 1-6	3 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Week 16	Patients 7-12	3 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Week 16	Patients 13-18	4 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Week 16	Patients 7-12	3 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Week 16	Patients 1-6	2 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Week 16	Patients 19-24	3 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Week 16	Patients 13-18	3 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Week 16	Patients 13-18	4 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Week 16	Patients 1-6	2 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Week 16	Patients 19-24	3 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Week 16	Patients 7-12	3 score on a scale
Placebo-clomiphene-anastrazole	EHS (Erectile Hardness Score) - Week 16	Patients 1-6	4 score on a scale
Placebo-clomiphene-anastrazole	EHS (Erectile Hardness Score) - Week 16	Patients 13-18	1 score on a scale
Placebo-clomiphene-anastrazole	EHS (Erectile Hardness Score) - Week 16	Patients 7-12	2 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Week 16	Patients 19-24	1 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Week 16	Patients 1-6	3 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Week 16	Patients 7-12	3 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Week 16	Patients 13-18	0 score on a scale

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

Time frame: Week 24

Population: Score 0-4 at the end of Week 24 no data was collected for patient 15 in clomiphene-anastrazole-placebo no data was collected for patient 23 in placebo-clomiphene-anastrazole

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Week 24	Patients 7-12	3 score on a scale
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Week 24	Patients 19-24	3 score on a scale
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Week 24	Patients 13-18	3 score on a scale
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Week 24	Patients 1-6	3 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Week 24	Patients 19-24	1 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Week 24	Patients 1-6	4 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Week 24	Patients 7-12	3 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Week 24	Patients 13-18	4 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Week 24	Patients 7-12	3 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Week 24	Patients 1-6	2 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Week 24	Patients 19-24	3 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Week 24	Patients 13-18	4 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Week 24	Patients 19-24	3 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Week 24	Patients 1-6	2 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Week 24	Patients 7-12	2 score on a scale
Placebo-clomiphene-anastrazole	EHS (Erectile Hardness Score) - Week 24	Patients 13-18	1 score on a scale
Placebo-clomiphene-anastrazole	EHS (Erectile Hardness Score) - Week 24	Patients 7-12	2 score on a scale
Placebo-clomiphene-anastrazole	EHS (Erectile Hardness Score) - Week 24	Patients 1-6	3 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Week 24	Patients 19-24	1 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Week 24	Patients 1-6	3 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Week 24	Patients 7-12	3 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Week 24	Patients 13-18	1 score on a scale

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

Time frame: Week 8

Population: Score 0-4 at the end of Week 8

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Week 8	Patients 1-6	1 score on a scale
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Week 8	Patients 7-12	3 score on a scale
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Week 8	Patients 13-18	3 score on a scale
Anastrazole-clomiphene-placebo	EHS (Erectile Hardness Score) - Week 8	Patients 19-24	3 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Week 8	Patients 13-18	3 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Week 8	Patients 7-12	3 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Week 8	Patients 1-6	4 score on a scale
Anastrazole-placebo-clomiphene	EHS (Erectile Hardness Score) - Week 8	Patients 19-24	3 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Week 8	Patients 19-24	3 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Week 8	Patients 13-18	3 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Week 8	Patients 7-12	3 score on a scale
Clomiphene-anastrazole-placebo	EHS (Erectile Hardness Score) - Week 8	Patients 1-6	1 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Week 8	Patients 1-6	1 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Week 8	Patients 19-24	2 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Week 8	Patients 7-12	2 score on a scale
Clomiphene-placebo-anastrazole	EHS (Erectile Hardness Score) - Week 8	Patients 13-18	3 score on a scale
Placebo-clomiphene-anastrazole	EHS (Erectile Hardness Score) - Week 8	Patients 13-18	1 score on a scale
Placebo-clomiphene-anastrazole	EHS (Erectile Hardness Score) - Week 8	Patients 19-24	1 score on a scale
Placebo-clomiphene-anastrazole	EHS (Erectile Hardness Score) - Week 8	Patients 7-12	4 score on a scale
Placebo-clomiphene-anastrazole	EHS (Erectile Hardness Score) - Week 8	Patients 1-6	3 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Week 8	Patients 7-12	2 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Week 8	Patients 13-18	3 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Week 8	Patients 19-24	3 score on a scale
Placebo-anastrazole-clomiphene	EHS (Erectile Hardness Score) - Week 8	Patients 1-6	1 score on a scale

Secondary

Estradiol - Screen

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

Time frame: Baseline

Population: Estradiol measurement at initial encounter~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	Estradiol - Screen	Patients 1-6	21.6 pg/mL
Anastrazole-clomiphene-placebo	Estradiol - Screen	Patients 7-12	9 pg/mL
Anastrazole-clomiphene-placebo	Estradiol - Screen	Patients 19-24	9.5 pg/mL
Anastrazole-clomiphene-placebo	Estradiol - Screen	Patients 13-18	13.3 pg/mL
Anastrazole-placebo-clomiphene	Estradiol - Screen	Patients 19-24	15.5 pg/mL
Anastrazole-placebo-clomiphene	Estradiol - Screen	Patients 13-18	20.1 pg/mL
Anastrazole-placebo-clomiphene	Estradiol - Screen	Patients 1-6	8.1 pg/mL
Anastrazole-placebo-clomiphene	Estradiol - Screen	Patients 7-12	19.3 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Screen	Patients 19-24	26.6 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Screen	Patients 1-6	9.6 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Screen	Patients 7-12	21.3 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Screen	Patients 13-18	16.2 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Screen	Patients 7-12	11.4 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Screen	Patients 1-6	13.5 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Screen	Patients 19-24	11 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Screen	Patients 13-18	14.1 pg/mL
Placebo-clomiphene-anastrazole	Estradiol - Screen	Patients 13-18	15.9 pg/mL
Placebo-clomiphene-anastrazole	Estradiol - Screen	Patients 1-6	15.9 pg/mL
Placebo-clomiphene-anastrazole	Estradiol - Screen	Patients 7-12	18.6 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Screen	Patients 7-12	10.9 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Screen	Patients 13-18	13.1 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Screen	Patients 19-24	26.8 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Screen	Patients 1-6	18.4 pg/mL

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

Time frame: Week 16

Population: Estradiol measurement at the end of Week 16 Data was not collected for patient 2 in anastrazole-placebo-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	Estradiol - Week 16	Patients 1-6	39.5 pg/mL
Anastrazole-clomiphene-placebo	Estradiol - Week 16	Patients 7-12	13.1 pg/mL
Anastrazole-clomiphene-placebo	Estradiol - Week 16	Patients 13-18	20.1 pg/mL
Anastrazole-clomiphene-placebo	Estradiol - Week 16	Patients 19-24	48.5 pg/mL
Anastrazole-placebo-clomiphene	Estradiol - Week 16	Patients 19-24	28.3 pg/mL
Anastrazole-placebo-clomiphene	Estradiol - Week 16	Patients 13-18	15 pg/mL
Anastrazole-placebo-clomiphene	Estradiol - Week 16	Patients 7-12	21.6 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Week 16	Patients 19-24	14.8 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Week 16	Patients 1-6	8.9 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Week 16	Patients 7-12	12.8 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Week 16	Patients 13-18	23.8 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Week 16	Patients 19-24	15.9 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Week 16	Patients 7-12	14.4 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Week 16	Patients 13-18	13.1 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Week 16	Patients 1-6	17.9 pg/mL
Placebo-clomiphene-anastrazole	Estradiol - Week 16	Patients 1-6	56.9 pg/mL
Placebo-clomiphene-anastrazole	Estradiol - Week 16	Patients 7-12	28.2 pg/mL
Placebo-clomiphene-anastrazole	Estradiol - Week 16	Patients 13-18	37 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Week 16	Patients 19-24	4.9 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Week 16	Patients 13-18	4.9 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Week 16	Patients 7-12	6.8 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Week 16	Patients 1-6	5 pg/mL

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

Time frame: Week 24

Population: Estradiol measurement at the end of Week 24~Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	Estradiol - Week 24	Patients 1-6	22.5 pg/mL
Anastrazole-clomiphene-placebo	Estradiol - Week 24	Patients 19-24	22.2 pg/mL
Anastrazole-clomiphene-placebo	Estradiol - Week 24	Patients 7-12	12.5 pg/mL
Anastrazole-clomiphene-placebo	Estradiol - Week 24	Patients 13-18	25.5 pg/mL
Anastrazole-placebo-clomiphene	Estradiol - Week 24	Patients 19-24	39.4 pg/mL
Anastrazole-placebo-clomiphene	Estradiol - Week 24	Patients 13-18	36.4 pg/mL
Anastrazole-placebo-clomiphene	Estradiol - Week 24	Patients 1-6	43.9 pg/mL
Anastrazole-placebo-clomiphene	Estradiol - Week 24	Patients 7-12	49.1 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Week 24	Patients 7-12	6.6 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Week 24	Patients 1-6	16.2 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Week 24	Patients 19-24	19 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Week 24	Patients 19-24	4.9 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Week 24	Patients 1-6	9.5 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Week 24	Patients 7-12	5 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Week 24	Patients 13-18	9.2 pg/mL
Placebo-clomiphene-anastrazole	Estradiol - Week 24	Patients 13-18	4.9 pg/mL
Placebo-clomiphene-anastrazole	Estradiol - Week 24	Patients 7-12	11.6 pg/mL
Placebo-clomiphene-anastrazole	Estradiol - Week 24	Patients 1-6	18.1 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Week 24	Patients 13-18	29.3 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Week 24	Patients 7-12	85.9 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Week 24	Patients 1-6	41.1 pg/mL

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

Time frame: Week 8

Population: Estradiol measurement at the end of Week 8~Data was not collected for patient 2 in anastrazole-placebo-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	Estradiol - Week 8	Patients 1-6	11.2 pg/mL
Anastrazole-clomiphene-placebo	Estradiol - Week 8	Patients 13-18	9.7 pg/mL
Anastrazole-clomiphene-placebo	Estradiol - Week 8	Patients 19-24	7.4 pg/mL
Anastrazole-clomiphene-placebo	Estradiol - Week 8	Patients 7-12	7 pg/mL
Anastrazole-placebo-clomiphene	Estradiol - Week 8	Patients 19-24	10.7 pg/mL
Anastrazole-placebo-clomiphene	Estradiol - Week 8	Patients 7-12	15.1 pg/mL
Anastrazole-placebo-clomiphene	Estradiol - Week 8	Patients 13-18	4.9 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Week 8	Patients 1-6	49.8 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Week 8	Patients 7-12	70.1 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Week 8	Patients 13-18	25.1 pg/mL
Clomiphene-anastrazole-placebo	Estradiol - Week 8	Patients 19-24	51.7 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Week 8	Patients 7-12	45 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Week 8	Patients 1-6	94.5 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Week 8	Patients 19-24	39.1 pg/mL
Clomiphene-placebo-anastrazole	Estradiol - Week 8	Patients 13-18	33.5 pg/mL
Placebo-clomiphene-anastrazole	Estradiol - Week 8	Patients 7-12	18.5 pg/mL
Placebo-clomiphene-anastrazole	Estradiol - Week 8	Patients 13-18	10 pg/mL
Placebo-clomiphene-anastrazole	Estradiol - Week 8	Patients 1-6	20.8 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Week 8	Patients 13-18	15.9 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Week 8	Patients 19-24	27.4 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Week 8	Patients 7-12	9.3 pg/mL
Placebo-anastrazole-clomiphene	Estradiol - Week 8	Patients 1-6	22.5 pg/mL

Secondary

Free Testosterone - Screen

Measure of Free Testosterone

Time frame: Baseline

Population: FT measured at initial encounter~Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	Free Testosterone - Screen	Patients 1-6	8.4 ng/dl
Anastrazole-clomiphene-placebo	Free Testosterone - Screen	Patients 13-18	9.56 ng/dl
Anastrazole-clomiphene-placebo	Free Testosterone - Screen	Patients 7-12	6.74 ng/dl
Anastrazole-clomiphene-placebo	Free Testosterone - Screen	Patients 19-24	2.19 ng/dl
Anastrazole-placebo-clomiphene	Free Testosterone - Screen	Patients 7-12	9.31 ng/dl
Anastrazole-placebo-clomiphene	Free Testosterone - Screen	Patients 19-24	7.27 ng/dl
Anastrazole-placebo-clomiphene	Free Testosterone - Screen	Patients 13-18	12.27 ng/dl
Anastrazole-placebo-clomiphene	Free Testosterone - Screen	Patients 1-6	6.99 ng/dl
Clomiphene-anastrazole-placebo	Free Testosterone - Screen	Patients 1-6	7.28 ng/dl
Clomiphene-anastrazole-placebo	Free Testosterone - Screen	Patients 7-12	6.07 ng/dl
Clomiphene-anastrazole-placebo	Free Testosterone - Screen	Patients 19-24	6.52 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Screen	Patients 13-18	4.86 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Screen	Patients 19-24	7.71 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Screen	Patients 1-6	8.82 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Screen	Patients 7-12	9.9 ng/dl
Placebo-clomiphene-anastrazole	Free Testosterone - Screen	Patients 7-12	5.82 ng/dl
Placebo-clomiphene-anastrazole	Free Testosterone - Screen	Patients 1-6	6.27 ng/dl
Placebo-clomiphene-anastrazole	Free Testosterone - Screen	Patients 13-18	9.49 ng/dl
Placebo-anastrazole-clomiphene	Free Testosterone - Screen	Patients 7-12	5.78 ng/dl
Placebo-anastrazole-clomiphene	Free Testosterone - Screen	Patients 1-6	7.86 ng/dl
Placebo-anastrazole-clomiphene	Free Testosterone - Screen	Patients 19-24	6.33 ng/dl

Secondary

Free Testosterone - Week 16

Measure of Free Testosterone

Time frame: Week 16

Population: FT measured at the end of Week 16~Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 22 in clomiphene-placebo-anastrazole arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	Free Testosterone - Week 16	Patients 13-18	10.17 ng/dl
Anastrazole-clomiphene-placebo	Free Testosterone - Week 16	Patients 7-12	8.83 ng/dl
Anastrazole-clomiphene-placebo	Free Testosterone - Week 16	Patients 19-24	14.98 ng/dl
Anastrazole-clomiphene-placebo	Free Testosterone - Week 16	Patients 1-6	14.16 ng/dl
Anastrazole-placebo-clomiphene	Free Testosterone - Week 16	Patients 13-18	5.98 ng/dl
Anastrazole-placebo-clomiphene	Free Testosterone - Week 16	Patients 1-6	16.37 ng/dl
Anastrazole-placebo-clomiphene	Free Testosterone - Week 16	Patients 7-12	5.7 ng/dl
Anastrazole-placebo-clomiphene	Free Testosterone - Week 16	Patients 19-24	9.46 ng/dl
Clomiphene-anastrazole-placebo	Free Testosterone - Week 16	Patients 7-12	14.7 ng/dl
Clomiphene-anastrazole-placebo	Free Testosterone - Week 16	Patients 19-24	11.22 ng/dl
Clomiphene-anastrazole-placebo	Free Testosterone - Week 16	Patients 1-6	12.27 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Week 16	Patients 7-12	9.63 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Week 16	Patients 1-6	12.67 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Week 16	Patients 13-18	6.63 ng/dl
Placebo-clomiphene-anastrazole	Free Testosterone - Week 16	Patients 7-12	14.57 ng/dl
Placebo-clomiphene-anastrazole	Free Testosterone - Week 16	Patients 1-6	19.21 ng/dl
Placebo-clomiphene-anastrazole	Free Testosterone - Week 16	Patients 13-18	16.38 ng/dl
Placebo-anastrazole-clomiphene	Free Testosterone - Week 16	Patients 13-18	7.58 ng/dl
Placebo-anastrazole-clomiphene	Free Testosterone - Week 16	Patients 7-12	13.47 ng/dl
Placebo-anastrazole-clomiphene	Free Testosterone - Week 16	Patients 1-6	17.47 ng/dl
Placebo-anastrazole-clomiphene	Free Testosterone - Week 16	Patients 19-24	11.62 ng/dl

Secondary

Free Testosterone - Week 24

Measure of Free Testosterone

Time frame: Week 24

Population: FT measured at the end of Week 24 Data not collected for patient 8 in APC arm Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm No data collected pt 24 in PAC arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	Free Testosterone - Week 24	Patients 1-6	10.51 ng/dl
Anastrazole-clomiphene-placebo	Free Testosterone - Week 24	Patients 19-24	5.82 ng/dl
Anastrazole-clomiphene-placebo	Free Testosterone - Week 24	Patients 7-12	6.11 ng/dl
Anastrazole-clomiphene-placebo	Free Testosterone - Week 24	Patients 13-18	11.82 ng/dl
Anastrazole-placebo-clomiphene	Free Testosterone - Week 24	Patients 19-24	13.54 ng/dl
Anastrazole-placebo-clomiphene	Free Testosterone - Week 24	Patients 13-18	13.74 ng/dl
Anastrazole-placebo-clomiphene	Free Testosterone - Week 24	Patients 1-6	19.35 ng/dl
Clomiphene-anastrazole-placebo	Free Testosterone - Week 24	Patients 7-12	11.09 ng/dl
Clomiphene-anastrazole-placebo	Free Testosterone - Week 24	Patients 1-6	6.25 ng/dl
Clomiphene-anastrazole-placebo	Free Testosterone - Week 24	Patients 19-24	6.11 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Week 24	Patients 19-24	16.82 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Week 24	Patients 1-6	11.28 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Week 24	Patients 7-12	17.89 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Week 24	Patients 13-18	18.19 ng/dl
Placebo-clomiphene-anastrazole	Free Testosterone - Week 24	Patients 13-18	15.49 ng/dl
Placebo-clomiphene-anastrazole	Free Testosterone - Week 24	Patients 7-12	11.63 ng/dl
Placebo-clomiphene-anastrazole	Free Testosterone - Week 24	Patients 1-6	8.65 ng/dl
Placebo-anastrazole-clomiphene	Free Testosterone - Week 24	Patients 7-12	25.27 ng/dl
Placebo-anastrazole-clomiphene	Free Testosterone - Week 24	Patients 1-6	19.31 ng/dl

Secondary

Free Testosterone - Week 8

Measure of Free Testosterone

Time frame: Week 8

Population: FT measured at the end of Week 8 Data was not collected for patient 8 in anastrazole-placebo-clomiphene arm Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	Free Testosterone - Week 8	Patients 19-24	17.44 ng/dl
Anastrazole-clomiphene-placebo	Free Testosterone - Week 8	Patients 13-18	21.61 ng/dl
Anastrazole-clomiphene-placebo	Free Testosterone - Week 8	Patients 1-6	19.46 ng/dl
Anastrazole-clomiphene-placebo	Free Testosterone - Week 8	Patients 7-12	15.63 ng/dl
Anastrazole-placebo-clomiphene	Free Testosterone - Week 8	Patients 13-18	15.18 ng/dl
Anastrazole-placebo-clomiphene	Free Testosterone - Week 8	Patients 1-6	21.8 ng/dl
Anastrazole-placebo-clomiphene	Free Testosterone - Week 8	Patients 19-24	20.01 ng/dl
Clomiphene-anastrazole-placebo	Free Testosterone - Week 8	Patients 19-24	11.37 ng/dl
Clomiphene-anastrazole-placebo	Free Testosterone - Week 8	Patients 7-12	19.33 ng/dl
Clomiphene-anastrazole-placebo	Free Testosterone - Week 8	Patients 1-6	17.72 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Week 8	Patients 13-18	21.71 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Week 8	Patients 7-12	27.79 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Week 8	Patients 19-24	15.71 ng/dl
Clomiphene-placebo-anastrazole	Free Testosterone - Week 8	Patients 1-6	35.27 ng/dl
Placebo-clomiphene-anastrazole	Free Testosterone - Week 8	Patients 13-18	8.91 ng/dl
Placebo-clomiphene-anastrazole	Free Testosterone - Week 8	Patients 1-6	2.71 ng/dl
Placebo-clomiphene-anastrazole	Free Testosterone - Week 8	Patients 7-12	9.4 ng/dl
Placebo-anastrazole-clomiphene	Free Testosterone - Week 8	Patients 19-24	6.04 ng/dl
Placebo-anastrazole-clomiphene	Free Testosterone - Week 8	Patients 1-6	12.3 ng/dl
Placebo-anastrazole-clomiphene	Free Testosterone - Week 8	Patients 7-12	5.3 ng/dl

Secondary

FSH - Screen

Lab Values for follicle stimulating hormone

Time frame: Baseline

Population: FSH measured at initial encounter~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	FSH - Screen	Patients 7-12	5.7 IU/L
Anastrazole-clomiphene-placebo	FSH - Screen	Patients 19-24	5.5 IU/L
Anastrazole-clomiphene-placebo	FSH - Screen	Patients 13-18	1.6 IU/L
Anastrazole-clomiphene-placebo	FSH - Screen	Patients 1-6	2.7 IU/L
Anastrazole-placebo-clomiphene	FSH - Screen	Patients 19-24	10 IU/L
Anastrazole-placebo-clomiphene	FSH - Screen	Patients 1-6	2.4 IU/L
Anastrazole-placebo-clomiphene	FSH - Screen	Patients 7-12	3.7 IU/L
Anastrazole-placebo-clomiphene	FSH - Screen	Patients 13-18	5.1 IU/L
Clomiphene-anastrazole-placebo	FSH - Screen	Patients 7-12	3.9 IU/L
Clomiphene-anastrazole-placebo	FSH - Screen	Patients 1-6	5.5 IU/L
Clomiphene-anastrazole-placebo	FSH - Screen	Patients 19-24	4.5 IU/L
Clomiphene-anastrazole-placebo	FSH - Screen	Patients 13-18	1.7 IU/L
Clomiphene-placebo-anastrazole	FSH - Screen	Patients 13-18	4 IU/L
Clomiphene-placebo-anastrazole	FSH - Screen	Patients 1-6	4.5 IU/L
Clomiphene-placebo-anastrazole	FSH - Screen	Patients 19-24	4.4 IU/L
Clomiphene-placebo-anastrazole	FSH - Screen	Patients 7-12	2.9 IU/L
Placebo-clomiphene-anastrazole	FSH - Screen	Patients 1-6	3.3 IU/L
Placebo-clomiphene-anastrazole	FSH - Screen	Patients 13-18	4.4 IU/L
Placebo-clomiphene-anastrazole	FSH - Screen	Patients 7-12	1.8 IU/L
Placebo-anastrazole-clomiphene	FSH - Screen	Patients 19-24	5.1 IU/L
Placebo-anastrazole-clomiphene	FSH - Screen	Patients 1-6	3.6 IU/L
Placebo-anastrazole-clomiphene	FSH - Screen	Patients 7-12	3.5 IU/L
Placebo-anastrazole-clomiphene	FSH - Screen	Patients 13-18	5.7 IU/L

Secondary

FSH - Week 16

Lab Values for follicle stimulating hormone

Time frame: Week 16

Population: FSH measured at Week 16~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	FSH - Week 16	Patients 1-6	7 IU/L
Anastrazole-clomiphene-placebo	FSH - Week 16	Patients 19-24	12.8 IU/L
Anastrazole-clomiphene-placebo	FSH - Week 16	Patients 7-12	7.2 IU/L
Anastrazole-clomiphene-placebo	FSH - Week 16	Patients 13-18	1.9 IU/L
Anastrazole-placebo-clomiphene	FSH - Week 16	Patients 19-24	11.4 IU/L
Anastrazole-placebo-clomiphene	FSH - Week 16	Patients 1-6	4.3 IU/L
Anastrazole-placebo-clomiphene	FSH - Week 16	Patients 7-12	3.7 IU/L
Anastrazole-placebo-clomiphene	FSH - Week 16	Patients 13-18	3.8 IU/L
Clomiphene-anastrazole-placebo	FSH - Week 16	Patients 13-18	1.2 IU/L
Clomiphene-anastrazole-placebo	FSH - Week 16	Patients 19-24	6.2 IU/L
Clomiphene-anastrazole-placebo	FSH - Week 16	Patients 7-12	6 IU/L
Clomiphene-anastrazole-placebo	FSH - Week 16	Patients 1-6	4.2 IU/L
Clomiphene-placebo-anastrazole	FSH - Week 16	Patients 1-6	5.3 IU/L
Clomiphene-placebo-anastrazole	FSH - Week 16	Patients 19-24	4.2 IU/L
Clomiphene-placebo-anastrazole	FSH - Week 16	Patients 13-18	3.3 IU/L
Clomiphene-placebo-anastrazole	FSH - Week 16	Patients 7-12	2.9 IU/L
Placebo-clomiphene-anastrazole	FSH - Week 16	Patients 1-6	10.7 IU/L
Placebo-clomiphene-anastrazole	FSH - Week 16	Patients 13-18	8.3 IU/L
Placebo-clomiphene-anastrazole	FSH - Week 16	Patients 7-12	2.6 IU/L
Placebo-anastrazole-clomiphene	FSH - Week 16	Patients 7-12	6.5 IU/L
Placebo-anastrazole-clomiphene	FSH - Week 16	Patients 19-24	8.9 IU/L
Placebo-anastrazole-clomiphene	FSH - Week 16	Patients 13-18	11.5 IU/L
Placebo-anastrazole-clomiphene	FSH - Week 16	Patients 1-6	6.8 IU/L

Secondary

FSH - Week 24

Lab Values for follicle stimulating hormone

Time frame: Week 24

Population: FSH measured at Week 24 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	FSH - Week 24	Patients 1-6	4.1 IU/L
Anastrazole-clomiphene-placebo	FSH - Week 24	Patients 19-24	4.8 IU/L
Anastrazole-clomiphene-placebo	FSH - Week 24	Patients 7-12	4.4 IU/L
Anastrazole-clomiphene-placebo	FSH - Week 24	Patients 13-18	2 IU/L
Anastrazole-placebo-clomiphene	FSH - Week 24	Patients 19-24	29.7 IU/L
Anastrazole-placebo-clomiphene	FSH - Week 24	Patients 13-18	7.2 IU/L
Anastrazole-placebo-clomiphene	FSH - Week 24	Patients 1-6	4.8 IU/L
Anastrazole-placebo-clomiphene	FSH - Week 24	Patients 7-12	15.1 IU/L
Clomiphene-anastrazole-placebo	FSH - Week 24	Patients 7-12	6 IU/L
Clomiphene-anastrazole-placebo	FSH - Week 24	Patients 1-6	3 IU/L
Clomiphene-anastrazole-placebo	FSH - Week 24	Patients 19-24	5 IU/L
Clomiphene-placebo-anastrazole	FSH - Week 24	Patients 19-24	5.8 IU/L
Clomiphene-placebo-anastrazole	FSH - Week 24	Patients 1-6	5.2 IU/L
Clomiphene-placebo-anastrazole	FSH - Week 24	Patients 7-12	3.7 IU/L
Clomiphene-placebo-anastrazole	FSH - Week 24	Patients 13-18	7.2 IU/L
Placebo-clomiphene-anastrazole	FSH - Week 24	Patients 13-18	5.9 IU/L
Placebo-clomiphene-anastrazole	FSH - Week 24	Patients 7-12	5.2 IU/L
Placebo-clomiphene-anastrazole	FSH - Week 24	Patients 1-6	6.5 IU/L
Placebo-anastrazole-clomiphene	FSH - Week 24	Patients 13-18	10.4 IU/L
Placebo-anastrazole-clomiphene	FSH - Week 24	Patients 7-12	14.5 IU/L
Placebo-anastrazole-clomiphene	FSH - Week 24	Patients 1-6	4 IU/L

Secondary

FSH - Week 8

Lab Values for follicle stimulating hormone

Time frame: Week 8

Population: FSH measured at Week 8~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	FSH - Week 8	Patients 7-12	7.7 IU/L
Anastrazole-clomiphene-placebo	FSH - Week 8	Patients 19-24	11.3 IU/L
Anastrazole-clomiphene-placebo	FSH - Week 8	Patients 13-18	3 IU/L
Anastrazole-clomiphene-placebo	FSH - Week 8	Patients 1-6	5.4 IU/L
Anastrazole-placebo-clomiphene	FSH - Week 8	Patients 19-24	20.3 IU/L
Anastrazole-placebo-clomiphene	FSH - Week 8	Patients 1-6	4.3 IU/L
Anastrazole-placebo-clomiphene	FSH - Week 8	Patients 7-12	6.2 IU/L
Anastrazole-placebo-clomiphene	FSH - Week 8	Patients 13-18	8.3 IU/L
Clomiphene-anastrazole-placebo	FSH - Week 8	Patients 7-12	7.8 IU/L
Clomiphene-anastrazole-placebo	FSH - Week 8	Patients 1-6	8.2 IU/L
Clomiphene-anastrazole-placebo	FSH - Week 8	Patients 19-24	6.1 IU/L
Clomiphene-anastrazole-placebo	FSH - Week 8	Patients 13-18	1.8 IU/L
Clomiphene-placebo-anastrazole	FSH - Week 8	Patients 13-18	6.3 IU/L
Clomiphene-placebo-anastrazole	FSH - Week 8	Patients 1-6	16.2 IU/L
Clomiphene-placebo-anastrazole	FSH - Week 8	Patients 19-24	8.1 IU/L
Clomiphene-placebo-anastrazole	FSH - Week 8	Patients 7-12	3.03 IU/L
Placebo-clomiphene-anastrazole	FSH - Week 8	Patients 1-6	3.4 IU/L
Placebo-clomiphene-anastrazole	FSH - Week 8	Patients 13-18	4.7 IU/L
Placebo-clomiphene-anastrazole	FSH - Week 8	Patients 7-12	2.2 IU/L
Placebo-anastrazole-clomiphene	FSH - Week 8	Patients 19-24	4.4 IU/L
Placebo-anastrazole-clomiphene	FSH - Week 8	Patients 1-6	4.1 IU/L
Placebo-anastrazole-clomiphene	FSH - Week 8	Patients 7-12	4.2 IU/L
Placebo-anastrazole-clomiphene	FSH - Week 8	Patients 13-18	6 IU/L

Secondary

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

Population: LH measured at initial encounter~Data for pt 23 in placebo-clomiphene-anastrazole not collected

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	LH - Screen	Patients 7-12	3.4 IU/L
Anastrazole-clomiphene-placebo	LH - Screen	Patients 19-24	6.3 IU/L
Anastrazole-clomiphene-placebo	LH - Screen	Patients 1-6	3.5 IU/L
Anastrazole-clomiphene-placebo	LH - Screen	Patients 13-18	1.1 IU/L
Anastrazole-placebo-clomiphene	LH - Screen	Patients 19-24	4.1 IU/L
Anastrazole-placebo-clomiphene	LH - Screen	Patients 13-18	3.5 IU/L
Anastrazole-placebo-clomiphene	LH - Screen	Patients 7-12	3.8 IU/L
Anastrazole-placebo-clomiphene	LH - Screen	Patients 1-6	3.6 IU/L
Clomiphene-anastrazole-placebo	LH - Screen	Patients 1-6	3.8 IU/L
Clomiphene-anastrazole-placebo	LH - Screen	Patients 13-18	4.1 IU/L
Clomiphene-anastrazole-placebo	LH - Screen	Patients 19-24	4.7 IU/L
Clomiphene-anastrazole-placebo	LH - Screen	Patients 7-12	2.4 IU/L
Clomiphene-placebo-anastrazole	LH - Screen	Patients 19-24	5.9 IU/L
Clomiphene-placebo-anastrazole	LH - Screen	Patients 13-18	3.3 IU/L
Clomiphene-placebo-anastrazole	LH - Screen	Patients 1-6	6.8 IU/L
Clomiphene-placebo-anastrazole	LH - Screen	Patients 7-12	4.1 IU/L
Placebo-clomiphene-anastrazole	LH - Screen	Patients 7-12	2.4 IU/L
Placebo-clomiphene-anastrazole	LH - Screen	Patients 13-18	6 IU/L
Placebo-clomiphene-anastrazole	LH - Screen	Patients 1-6	3.5 IU/L
Placebo-anastrazole-clomiphene	LH - Screen	Patients 19-24	6.8 IU/L
Placebo-anastrazole-clomiphene	LH - Screen	Patients 7-12	1.7 IU/L
Placebo-anastrazole-clomiphene	LH - Screen	Patients 13-18	3.1 IU/L
Placebo-anastrazole-clomiphene	LH - Screen	Patients 1-6	3.4 IU/L

Secondary

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

Population: LH measured at week 16~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	LH - Week 16	Patients 7-12	6.9 IU/L
Anastrazole-clomiphene-placebo	LH - Week 16	Patients 19-24	7.8 IU/L
Anastrazole-clomiphene-placebo	LH - Week 16	Patients 13-18	1.9 IU/L
Anastrazole-clomiphene-placebo	LH - Week 16	Patients 1-6	6.8 IU/L
Anastrazole-placebo-clomiphene	LH - Week 16	Patients 19-24	4.3 IU/L
Anastrazole-placebo-clomiphene	LH - Week 16	Patients 1-6	4.6 IU/L
Anastrazole-placebo-clomiphene	LH - Week 16	Patients 7-12	4.8 IU/L
Anastrazole-placebo-clomiphene	LH - Week 16	Patients 13-18	2.1 IU/L
Clomiphene-anastrazole-placebo	LH - Week 16	Patients 7-12	6.3 IU/L
Clomiphene-anastrazole-placebo	LH - Week 16	Patients 1-6	4.2 IU/L
Clomiphene-anastrazole-placebo	LH - Week 16	Patients 19-24	6.6 IU/L
Clomiphene-anastrazole-placebo	LH - Week 16	Patients 13-18	2.2 IU/L
Clomiphene-placebo-anastrazole	LH - Week 16	Patients 13-18	1.9 IU/L
Clomiphene-placebo-anastrazole	LH - Week 16	Patients 1-6	5.4 IU/L
Clomiphene-placebo-anastrazole	LH - Week 16	Patients 19-24	4.9 IU/L
Clomiphene-placebo-anastrazole	LH - Week 16	Patients 7-12	4.9 IU/L
Placebo-clomiphene-anastrazole	LH - Week 16	Patients 1-6	13.9 IU/L
Placebo-clomiphene-anastrazole	LH - Week 16	Patients 13-18	13 IU/L
Placebo-clomiphene-anastrazole	LH - Week 16	Patients 7-12	5.2 IU/L
Placebo-anastrazole-clomiphene	LH - Week 16	Patients 19-24	7.4 IU/L
Placebo-anastrazole-clomiphene	LH - Week 16	Patients 1-6	8.9 IU/L
Placebo-anastrazole-clomiphene	LH - Week 16	Patients 7-12	3.8 IU/L
Placebo-anastrazole-clomiphene	LH - Week 16	Patients 13-18	6.4 IU/L

Secondary

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

Population: LH measured at week 24~No data for patient 13 collected in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	LH - Week 24	Patients 1-6	3 IU/L
Anastrazole-clomiphene-placebo	LH - Week 24	Patients 7-12	6.1 IU/L
Anastrazole-clomiphene-placebo	LH - Week 24	Patients 19-24	2.7 IU/L
Anastrazole-clomiphene-placebo	LH - Week 24	Patients 13-18	2.2 IU/L
Anastrazole-placebo-clomiphene	LH - Week 24	Patients 1-6	4.1 IU/L
Anastrazole-placebo-clomiphene	LH - Week 24	Patients 19-24	15.1 IU/L
Anastrazole-placebo-clomiphene	LH - Week 24	Patients 13-18	5.4 IU/L
Anastrazole-placebo-clomiphene	LH - Week 24	Patients 7-12	12.6 IU/L
Clomiphene-anastrazole-placebo	LH - Week 24	Patients 19-24	4.7 IU/L
Clomiphene-anastrazole-placebo	LH - Week 24	Patients 7-12	5.9 IU/L
Clomiphene-anastrazole-placebo	LH - Week 24	Patients 1-6	3.4 IU/L
Clomiphene-placebo-anastrazole	LH - Week 24	Patients 7-12	6.4 IU/L
Clomiphene-placebo-anastrazole	LH - Week 24	Patients 13-18	7.6 IU/L
Clomiphene-placebo-anastrazole	LH - Week 24	Patients 19-24	5.4 IU/L
Clomiphene-placebo-anastrazole	LH - Week 24	Patients 1-6	6.4 IU/L
Placebo-clomiphene-anastrazole	LH - Week 24	Patients 1-6	5 IU/L
Placebo-clomiphene-anastrazole	LH - Week 24	Patients 13-18	7.1 IU/L
Placebo-clomiphene-anastrazole	LH - Week 24	Patients 7-12	2.9 IU/L
Placebo-anastrazole-clomiphene	LH - Week 24	Patients 1-6	7.7 IU/L
Placebo-anastrazole-clomiphene	LH - Week 24	Patients 13-18	8.1 IU/L
Placebo-anastrazole-clomiphene	LH - Week 24	Patients 7-12	10.5 IU/L

Secondary

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

Population: LH measured at week 8~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	LH - Week 8	Patients 7-12	5.2 IU/L
Anastrazole-clomiphene-placebo	LH - Week 8	Patients 19-24	4.2 IU/L
Anastrazole-clomiphene-placebo	LH - Week 8	Patients 13-18	2.9 IU/L
Anastrazole-clomiphene-placebo	LH - Week 8	Patients 1-6	9.1 IU/L
Anastrazole-placebo-clomiphene	LH - Week 8	Patients 19-24	11.5 IU/L
Anastrazole-placebo-clomiphene	LH - Week 8	Patients 1-6	5.1 IU/L
Anastrazole-placebo-clomiphene	LH - Week 8	Patients 7-12	4 IU/L
Anastrazole-placebo-clomiphene	LH - Week 8	Patients 13-18	6.9 IU/L
Clomiphene-anastrazole-placebo	LH - Week 8	Patients 7-12	10.7 IU/L
Clomiphene-anastrazole-placebo	LH - Week 8	Patients 1-6	9.9 IU/L
Clomiphene-anastrazole-placebo	LH - Week 8	Patients 19-24	7.5 IU/L
Clomiphene-anastrazole-placebo	LH - Week 8	Patients 13-18	6.1 IU/L
Clomiphene-placebo-anastrazole	LH - Week 8	Patients 13-18	4.7 IU/L
Clomiphene-placebo-anastrazole	LH - Week 8	Patients 1-6	17.3 IU/L
Clomiphene-placebo-anastrazole	LH - Week 8	Patients 19-24	6.9 IU/L
Clomiphene-placebo-anastrazole	LH - Week 8	Patients 7-12	12.6 IU/L
Placebo-clomiphene-anastrazole	LH - Week 8	Patients 1-6	3.6 IU/L
Placebo-clomiphene-anastrazole	LH - Week 8	Patients 13-18	6.7 IU/L
Placebo-clomiphene-anastrazole	LH - Week 8	Patients 7-12	3.3 IU/L
Placebo-anastrazole-clomiphene	LH - Week 8	Patients 19-24	7.3 IU/L
Placebo-anastrazole-clomiphene	LH - Week 8	Patients 1-6	6.3 IU/L
Placebo-anastrazole-clomiphene	LH - Week 8	Patients 7-12	1.9 IU/L
Placebo-anastrazole-clomiphene	LH - Week 8	Patients 13-18	3 IU/L

Secondary

Normalized Testosterone - Screen

Normalized at \>350ng/dl

Time frame: Baseline

Population: Normalized Testosterone measured week 0 - initial screen~Data not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	Normalized Testosterone - Screen	Patients 7-12	293 ng/dl
Anastrazole-clomiphene-placebo	Normalized Testosterone - Screen	Patients 19-24	95 ng/dl
Anastrazole-clomiphene-placebo	Normalized Testosterone - Screen	Patients 13-18	347 ng/dl
Anastrazole-clomiphene-placebo	Normalized Testosterone - Screen	Patients 1-6	205 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Screen	Patients 19-24	291 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Screen	Patients 1-6	330 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Screen	Patients 7-12	237 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Screen	Patients 13-18	328 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Screen	Patients 7-12	194 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Screen	Patients 1-6	226 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Screen	Patients 19-24	306 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Screen	Patients 13-18	268 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Screen	Patients 13-18	206 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Screen	Patients 1-6	367 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Screen	Patients 19-24	244 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Screen	Patients 7-12	300 ng/dl
Placebo-clomiphene-anastrazole	Normalized Testosterone - Screen	Patients 1-6	315 ng/dl
Placebo-clomiphene-anastrazole	Normalized Testosterone - Screen	Patients 13-18	321 ng/dl
Placebo-clomiphene-anastrazole	Normalized Testosterone - Screen	Patients 7-12	214 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Screen	Patients 19-24	289 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Screen	Patients 1-6	321 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Screen	Patients 7-12	243 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Screen	Patients 13-18	148 ng/dl

Secondary

Normalized Testosterone - Week 16

Normalized at \>350ng/dl

Time frame: Week 16

Population: Normalized Testosterone measured at the end of the 16th week~Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	Normalized Testosterone - Week 16	Patients 1-6	437 ng/dl
Anastrazole-clomiphene-placebo	Normalized Testosterone - Week 16	Patients 19-24	609 ng/dl
Anastrazole-clomiphene-placebo	Normalized Testosterone - Week 16	Patients 13-18	329 ng/dl
Anastrazole-clomiphene-placebo	Normalized Testosterone - Week 16	Patients 7-12	337 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Week 16	Patients 19-24	323 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Week 16	Patients 7-12	200 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Week 16	Patients 1-6	591 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Week 16	Patients 13-18	191 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Week 16	Patients 7-12	451 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Week 16	Patients 1-6	338 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Week 16	Patients 19-24	456 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Week 16	Patients 13-18	124 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Week 16	Patients 13-18	206 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Week 16	Patients 19-24	288 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Week 16	Patients 7-12	403 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Week 16	Patients 1-6	391 ng/dl
Placebo-clomiphene-anastrazole	Normalized Testosterone - Week 16	Patients 1-6	696 ng/dl
Placebo-clomiphene-anastrazole	Normalized Testosterone - Week 16	Patients 13-18	585 ng/dl
Placebo-clomiphene-anastrazole	Normalized Testosterone - Week 16	Patients 7-12	396 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Week 16	Patients 19-24	484 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Week 16	Patients 1-6	502 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Week 16	Patients 7-12	520 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Week 16	Patients 13-18	283 ng/dl

Secondary

Normalized Testosterone - Week 24

Normalized at \>350ng/dl

Time frame: Week 24

Population: Normalized Testosterone measured at the end of the 24th week~Data was not collected for patient 15 clomiphene-anastrazole-placebo Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	Normalized Testosterone - Week 24	Patients 1-6	268 ng/dl
Anastrazole-clomiphene-placebo	Normalized Testosterone - Week 24	Patients 19-24	196 ng/dl
Anastrazole-clomiphene-placebo	Normalized Testosterone - Week 24	Patients 7-12	269 ng/dl
Anastrazole-clomiphene-placebo	Normalized Testosterone - Week 24	Patients 13-18	446 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Week 24	Patients 19-24	630 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Week 24	Patients 13-18	449 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Week 24	Patients 1-6	793 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Week 24	Patients 7-12	519 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Week 24	Patients 7-12	440 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Week 24	Patients 1-6	214 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Week 24	Patients 19-24	274 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Week 24	Patients 19-24	486 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Week 24	Patients 1-6	537 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Week 24	Patients 7-12	531 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Week 24	Patients 13-18	447 ng/dl
Placebo-clomiphene-anastrazole	Normalized Testosterone - Week 24	Patients 13-18	487 ng/dl
Placebo-clomiphene-anastrazole	Normalized Testosterone - Week 24	Patients 7-12	375 ng/dl
Placebo-clomiphene-anastrazole	Normalized Testosterone - Week 24	Patients 1-6	412 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Week 24	Patients 13-18	195 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Week 24	Patients 7-12	972 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Week 24	Patients 1-6	596 ng/dl

Secondary

Normalized Testosterone - Week 8

Normalized at \>350ng/dl

Time frame: Week 8

Population: Normalized Testosterone measured at the end of the first 8 week period~Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	Normalized Testosterone - Week 8	Patients 13-18	607 ng/dl
Anastrazole-clomiphene-placebo	Normalized Testosterone - Week 8	Patients 7-12	387 ng/dl
Anastrazole-clomiphene-placebo	Normalized Testosterone - Week 8	Patients 19-24	545 ng/dl
Anastrazole-clomiphene-placebo	Normalized Testosterone - Week 8	Patients 1-6	484 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Week 8	Patients 1-6	757 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Week 8	Patients 19-24	676 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Week 8	Patients 13-18	453 ng/dl
Anastrazole-placebo-clomiphene	Normalized Testosterone - Week 8	Patients 7-12	296 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Week 8	Patients 19-24	592 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Week 8	Patients 1-6	566 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Week 8	Patients 7-12	693 ng/dl
Clomiphene-anastrazole-placebo	Normalized Testosterone - Week 8	Patients 13-18	216 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Week 8	Patients 7-12	917 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Week 8	Patients 1-6	1316 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Week 8	Patients 19-24	497 ng/dl
Clomiphene-placebo-anastrazole	Normalized Testosterone - Week 8	Patients 13-18	527 ng/dl
Placebo-clomiphene-anastrazole	Normalized Testosterone - Week 8	Patients 7-12	271 ng/dl
Placebo-clomiphene-anastrazole	Normalized Testosterone - Week 8	Patients 1-6	133 ng/dl
Placebo-clomiphene-anastrazole	Normalized Testosterone - Week 8	Patients 13-18	270 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Week 8	Patients 13-18	139 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Week 8	Patients 1-6	470 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Week 8	Patients 7-12	298 ng/dl
Placebo-anastrazole-clomiphene	Normalized Testosterone - Week 8	Patients 19-24	296 ng/dl

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

Time frame: Baseline

Population: SEP measured at the initial encounter~Baseline SPEP was not measured for participants 1-24~Table included for completeness

Arm	Measure	Group	Value
Unknown	SEP #1-3 Cumulative - Screen	Patients 13-18	—
Unknown	SEP #1-3 Cumulative - Screen	Patients 1-6	—
Unknown	SEP #1-3 Cumulative - Screen	Patients 7-12	—
Unknown	SEP #1-3 Cumulative - Screen	Patients 19-24	—

Secondary

SEP #1-3 Cumulative - Week 16

Time frame: Week 16

Population: SEP measured at the end of week 16~data not collected for pt 3,15 in CAP arm data not collected for pt 5,11,23 in PCA arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	SEP #1-3 Cumulative - Week 16	Patients 1-6	2 score on a scale
Anastrazole-clomiphene-placebo	SEP #1-3 Cumulative - Week 16	Patients 7-12	3 score on a scale
Anastrazole-clomiphene-placebo	SEP #1-3 Cumulative - Week 16	Patients 13-18	4 score on a scale
Anastrazole-clomiphene-placebo	SEP #1-3 Cumulative - Week 16	Patients 19-24	3 score on a scale
Anastrazole-placebo-clomiphene	SEP #1-3 Cumulative - Week 16	Patients 13-18	3 score on a scale
Anastrazole-placebo-clomiphene	SEP #1-3 Cumulative - Week 16	Patients 19-24	3 score on a scale
Anastrazole-placebo-clomiphene	SEP #1-3 Cumulative - Week 16	Patients 7-12	3 score on a scale
Anastrazole-placebo-clomiphene	SEP #1-3 Cumulative - Week 16	Patients 1-6	3 score on a scale
Clomiphene-anastrazole-placebo	SEP #1-3 Cumulative - Week 16	Patients 19-24	3 score on a scale
Clomiphene-anastrazole-placebo	SEP #1-3 Cumulative - Week 16	Patients 7-12	3 score on a scale
Clomiphene-placebo-anastrazole	SEP #1-3 Cumulative - Week 16	Patients 13-18	3 score on a scale
Clomiphene-placebo-anastrazole	SEP #1-3 Cumulative - Week 16	Patients 7-12	3 score on a scale
Clomiphene-placebo-anastrazole	SEP #1-3 Cumulative - Week 16	Patients 19-24	3 score on a scale
Clomiphene-placebo-anastrazole	SEP #1-3 Cumulative - Week 16	Patients 1-6	1 score on a scale
Placebo-clomiphene-anastrazole	SEP #1-3 Cumulative - Week 16	Patients 13-18	3 score on a scale
Placebo-anastrazole-clomiphene	SEP #1-3 Cumulative - Week 16	Patients 19-24	1 score on a scale
Placebo-anastrazole-clomiphene	SEP #1-3 Cumulative - Week 16	Patients 7-12	0 score on a scale
Placebo-anastrazole-clomiphene	SEP #1-3 Cumulative - Week 16	Patients 1-6	2 score on a scale
Placebo-anastrazole-clomiphene	SEP #1-3 Cumulative - Week 16	Patients 13-18	2 score on a scale

Secondary

SEP #1-3 Cumulative - Week 24

Time frame: Week 24

Population: SEP measured at the end of week 24 data not collected for pt 1,13 in ACP arm data not collected for pt 3, 15 in CAP arm data not collected for pt 22 in CPA arm data not collected for pt 11,23 PCA arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	SEP #1-3 Cumulative - Week 24	Patients 19-24	3 score on a scale
Anastrazole-clomiphene-placebo	SEP #1-3 Cumulative - Week 24	Patients 7-12	3 score on a scale
Anastrazole-placebo-clomiphene	SEP #1-3 Cumulative - Week 24	Patients 13-18	3 score on a scale
Anastrazole-placebo-clomiphene	SEP #1-3 Cumulative - Week 24	Patients 19-24	3 score on a scale
Anastrazole-placebo-clomiphene	SEP #1-3 Cumulative - Week 24	Patients 1-6	3 score on a scale
Anastrazole-placebo-clomiphene	SEP #1-3 Cumulative - Week 24	Patients 7-12	3 score on a scale
Clomiphene-anastrazole-placebo	SEP #1-3 Cumulative - Week 24	Patients 7-12	3 score on a scale
Clomiphene-anastrazole-placebo	SEP #1-3 Cumulative - Week 24	Patients 19-24	3 score on a scale
Clomiphene-placebo-anastrazole	SEP #1-3 Cumulative - Week 24	Patients 7-12	1 score on a scale
Clomiphene-placebo-anastrazole	SEP #1-3 Cumulative - Week 24	Patients 13-18	2 score on a scale
Clomiphene-placebo-anastrazole	SEP #1-3 Cumulative - Week 24	Patients 1-6	3 score on a scale
Placebo-clomiphene-anastrazole	SEP #1-3 Cumulative - Week 24	Patients 1-6	3 score on a scale
Placebo-clomiphene-anastrazole	SEP #1-3 Cumulative - Week 24	Patients 13-18	0 score on a scale
Placebo-anastrazole-clomiphene	SEP #1-3 Cumulative - Week 24	Patients 19-24	1 score on a scale
Placebo-anastrazole-clomiphene	SEP #1-3 Cumulative - Week 24	Patients 1-6	2 score on a scale
Placebo-anastrazole-clomiphene	SEP #1-3 Cumulative - Week 24	Patients 7-12	0 score on a scale
Placebo-anastrazole-clomiphene	SEP #1-3 Cumulative - Week 24	Patients 13-18	2 score on a scale

Secondary

SEP #1-3 Cumulative - Week 8

Time frame: Week 8

Population: SEP measured at the end of week 8~data not collected for pt 11,17 in PCA arm data not collected for pt 13 in ACP arm data not collected for pt 15 in CAP arm data not collected for pt 22 in CPA arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	SEP #1-3 Cumulative - Week 8	Patients 19-24	3 score on a scale
Anastrazole-clomiphene-placebo	SEP #1-3 Cumulative - Week 8	Patients 7-12	2 score on a scale
Anastrazole-clomiphene-placebo	SEP #1-3 Cumulative - Week 8	Patients 1-6	3 score on a scale
Anastrazole-placebo-clomiphene	SEP #1-3 Cumulative - Week 8	Patients 7-12	3 score on a scale
Anastrazole-placebo-clomiphene	SEP #1-3 Cumulative - Week 8	Patients 13-18	2 score on a scale
Anastrazole-placebo-clomiphene	SEP #1-3 Cumulative - Week 8	Patients 19-24	3 score on a scale
Anastrazole-placebo-clomiphene	SEP #1-3 Cumulative - Week 8	Patients 1-6	3 score on a scale
Clomiphene-anastrazole-placebo	SEP #1-3 Cumulative - Week 8	Patients 7-12	2 score on a scale
Clomiphene-anastrazole-placebo	SEP #1-3 Cumulative - Week 8	Patients 19-24	3 score on a scale
Clomiphene-anastrazole-placebo	SEP #1-3 Cumulative - Week 8	Patients 1-6	1 score on a scale
Clomiphene-placebo-anastrazole	SEP #1-3 Cumulative - Week 8	Patients 7-12	2 score on a scale
Clomiphene-placebo-anastrazole	SEP #1-3 Cumulative - Week 8	Patients 1-6	1 score on a scale
Clomiphene-placebo-anastrazole	SEP #1-3 Cumulative - Week 8	Patients 13-18	1 score on a scale
Placebo-clomiphene-anastrazole	SEP #1-3 Cumulative - Week 8	Patients 1-6	3 score on a scale
Placebo-clomiphene-anastrazole	SEP #1-3 Cumulative - Week 8	Patients 19-24	1 score on a scale
Placebo-anastrazole-clomiphene	SEP #1-3 Cumulative - Week 8	Patients 13-18	2 score on a scale
Placebo-anastrazole-clomiphene	SEP #1-3 Cumulative - Week 8	Patients 7-12	3 score on a scale
Placebo-anastrazole-clomiphene	SEP #1-3 Cumulative - Week 8	Patients 1-6	4 score on a scale
Placebo-anastrazole-clomiphene	SEP #1-3 Cumulative - Week 8	Patients 19-24	2 score on a scale

Secondary

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

Population: SHBG measured at initial encounter~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	SHBG - Screen	Patients 13-18	23.5 nmol/L
Anastrazole-clomiphene-placebo	SHBG - Screen	Patients 7-12	30.7 nmol/L
Anastrazole-clomiphene-placebo	SHBG - Screen	Patients 1-6	13.9 nmol/L
Anastrazole-clomiphene-placebo	SHBG - Screen	Patients 19-24	28.6 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Screen	Patients 7-12	12.6 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Screen	Patients 13-18	17.5 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Screen	Patients 19-24	22 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Screen	Patients 1-6	35.2 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Screen	Patients 13-18	21.4 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Screen	Patients 19-24	35.5 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Screen	Patients 1-6	20 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Screen	Patients 7-12	23.5 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Screen	Patients 19-24	11.6 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Screen	Patients 13-18	20 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Screen	Patients 7-12	26.4 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Screen	Patients 1-6	31.7 nmol/L
Placebo-clomiphene-anastrazole	SHBG - Screen	Patients 1-6	26.2 nmol/L
Placebo-clomiphene-anastrazole	SHBG - Screen	Patients 13-18	16.9 nmol/L
Placebo-clomiphene-anastrazole	SHBG - Screen	Patients 7-12	20.9 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Screen	Patients 19-24	30.6 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Screen	Patients 7-12	26.8 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Screen	Patients 13-18	14.8 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Screen	Patients 1-6	24.1 nmol/L

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

Time frame: Week 16

Population: SHBG measured at week 16~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	SHBG - Week 16	Patients 7-12	30.7 nmol/L
Anastrazole-clomiphene-placebo	SHBG - Week 16	Patients 19-24	39.3 nmol/L
Anastrazole-clomiphene-placebo	SHBG - Week 16	Patients 13-18	26.8 nmol/L
Anastrazole-clomiphene-placebo	SHBG - Week 16	Patients 1-6	22.3 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Week 16	Patients 19-24	24.8 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Week 16	Patients 1-6	35.5 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Week 16	Patients 7-12	15.3 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Week 16	Patients 13-18	17.2 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Week 16	Patients 7-12	26.6 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Week 16	Patients 1-6	13.8 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Week 16	Patients 19-24	35 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Week 16	Patients 13-18	14.2 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Week 16	Patients 13-18	22.8 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Week 16	Patients 1-6	16.4 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Week 16	Patients 19-24	13.9 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Week 16	Patients 7-12	31 nmol/L
Placebo-clomiphene-anastrazole	SHBG - Week 16	Patients 1-6	33.3 nmol/L
Placebo-clomiphene-anastrazole	SHBG - Week 16	Patients 13-18	17.2 nmol/L
Placebo-clomiphene-anastrazole	SHBG - Week 16	Patients 7-12	16.7 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Week 16	Patients 19-24	31 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Week 16	Patients 1-6	17.7 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Week 16	Patients 7-12	23 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Week 16	Patients 13-18	16.6 nmol/L

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

Time frame: Week 24

Population: SHBG measured at week 24~Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	SHBG - Week 24	Patients 19-24	23.2 nmol/L
Anastrazole-clomiphene-placebo	SHBG - Week 24	Patients 13-18	29 nmol/L
Anastrazole-clomiphene-placebo	SHBG - Week 24	Patients 1-6	14.6 nmol/L
Anastrazole-clomiphene-placebo	SHBG - Week 24	Patients 7-12	33.8 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Week 24	Patients 7-12	16 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Week 24	Patients 1-6	41.8 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Week 24	Patients 19-24	26 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Week 24	Patients 13-18	21.7 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Week 24	Patients 1-6	15.1 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Week 24	Patients 7-12	24.4 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Week 24	Patients 19-24	33.8 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Week 24	Patients 19-24	13.7 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Week 24	Patients 13-18	20.1 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Week 24	Patients 7-12	25.3 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Week 24	Patients 1-6	25.2 nmol/L
Placebo-clomiphene-anastrazole	SHBG - Week 24	Patients 7-12	13.8 nmol/L
Placebo-clomiphene-anastrazole	SHBG - Week 24	Patients 1-6	29.7 nmol/L
Placebo-clomiphene-anastrazole	SHBG - Week 24	Patients 13-18	17.3 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Week 24	Patients 1-6	23.6 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Week 24	Patients 13-18	17.5 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Week 24	Patients 7-12	34.1 nmol/L

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

Time frame: Week 8

Population: SHBG measured at week 8~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm

Arm	Measure	Group	Value (NUMBER)
Anastrazole-clomiphene-placebo	SHBG - Week 8	Patients 1-6	10 nmol/L
Anastrazole-clomiphene-placebo	SHBG - Week 8	Patients 7-12	23.4 nmol/L
Anastrazole-clomiphene-placebo	SHBG - Week 8	Patients 13-18	26.9 nmol/L
Anastrazole-clomiphene-placebo	SHBG - Week 8	Patients 19-24	28.1 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Week 8	Patients 19-24	20.1 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Week 8	Patients 1-6	38.2 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Week 8	Patients 7-12	12.7 nmol/L
Anastrazole-placebo-clomiphene	SHBG - Week 8	Patients 13-18	16.1 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Week 8	Patients 1-6	18.4 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Week 8	Patients 19-24	42.7 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Week 8	Patients 13-18	21.6 nmol/L
Clomiphene-anastrazole-placebo	SHBG - Week 8	Patients 7-12	26 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Week 8	Patients 13-18	30.9 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Week 8	Patients 19-24	20.9 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Week 8	Patients 7-12	27.2 nmol/L
Clomiphene-placebo-anastrazole	SHBG - Week 8	Patients 1-6	29.8 nmol/L
Placebo-clomiphene-anastrazole	SHBG - Week 8	Patients 13-18	14.3 nmol/L
Placebo-clomiphene-anastrazole	SHBG - Week 8	Patients 1-6	23.9 nmol/L
Placebo-clomiphene-anastrazole	SHBG - Week 8	Patients 7-12	24.1 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Week 8	Patients 19-24	30.7 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Week 8	Patients 1-6	21.6 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Week 8	Patients 7-12	25.7 nmol/L
Placebo-anastrazole-clomiphene	SHBG - Week 8	Patients 13-18	17.6 nmol/L

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Participant flow

Recruitment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

IIEF (International Index of Erectile Function) Score - Screen

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

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

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

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

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

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

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

EHS (Erectile Hardness Score) - Screen

EHS (Erectile Hardness Score) - Week 16

EHS (Erectile Hardness Score) - Week 24

EHS (Erectile Hardness Score) - Week 8

Estradiol - Screen

Estradiol - Week 16

Estradiol - Week 24

Estradiol - Week 8

Free Testosterone - Screen

Free Testosterone - Week 16

Free Testosterone - Week 24

Free Testosterone - Week 8

FSH - Screen

FSH - Week 16

FSH - Week 24

FSH - Week 8

LH - Screen

LH - Week 16

LH - Week 24

LH - Week 8

Normalized Testosterone - Screen

Normalized Testosterone - Week 16

Normalized Testosterone - Week 24

Normalized Testosterone - Week 8

SEP #1-3 Cumulative - Screen

SEP #1-3 Cumulative - Week 16

SEP #1-3 Cumulative - Week 24

SEP #1-3 Cumulative - Week 8

SHBG - Screen

SHBG - Week 16

SHBG - Week 24

SHBG - Week 8