Phase 2
N=24
Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function
Hypogonadism, Male
Bottom Line
View on ClinicalTrials.gov: NCT03933618 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Nov 2019
Primary outcome: Primary: IIEF (International Index of Erectile Function) Score - Screen — 34; 43; 57; 41 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anastrozole 1mg (Drug); Clomiphene Citrate 25mg (Drug); Placebo - Cap (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Albany Medical College
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IIEF (International Index of Erectile Function) Score - Screen |
34; 43; 57; 41; 57; 24 | — |
| PRIMARY IIEF (International Index of Erectile Function) Score - Week 8 |
25; 55; 32; 20; 66; 35 | — |
| PRIMARY IIEF (International Index of Erectile Function) Score - Week 16 |
45; 53; 35; 45; 66; 37 | — |
| PRIMARY IIEF (International Index of Erectile Function) Score - Week 24 |
12; 70; 42; 52; 65; 41 | — |
| SECONDARY Normalized Testosterone - Screen |
205; 330; 226; 367; 315; 321 | — |
| SECONDARY Normalized Testosterone - Week 8 |
484; 757; 566; 1316; 133; 470 | — |
| SECONDARY Normalized Testosterone - Week 16 |
437; 591; 338; 391; 696; 502 | — |
| SECONDARY Normalized Testosterone - Week 24 |
268; 793; 214; 537; 412; 596 | — |
| SECONDARY ADAM (Androgen Deficiency in the Aging Male) Score - Screen |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY ADAM (Androgen Deficiency in the Aging Male) Score - Week 8 |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY ADAM (Androgen Deficiency in the Aging Male) Score - Week 16 |
1; 1; 1; 1; 0; 1 | — |
| SECONDARY ADAM (Androgen Deficiency in the Aging Male) Score - Week 24 |
1; 0; 0; 1; 0; 1 | — |
| SECONDARY EHS (Erectile Hardness Score) - Screen |
3; 3; 3; 2; 3; 3 | — |
| SECONDARY EHS (Erectile Hardness Score) - Week 8 |
1; 4; 1; 1; 3; 1 | — |
| SECONDARY EHS (Erectile Hardness Score) - Week 16 |
3; 3; 2; 2; 4; 3 | — |
| SECONDARY EHS (Erectile Hardness Score) - Week 24 |
3; 4; 2; 2; 3; 3 | — |
| SECONDARY LH - Screen |
3.5; 3.6; 3.8; 6.8; 3.5; 3.4 | — |
| SECONDARY LH - Week 8 |
9.1; 5.1; 9.9; 17.3; 3.6; 6.3 | — |
| SECONDARY LH - Week 16 |
6.8; 4.6; 4.2; 5.4; 13.9; 8.9 | — |
| SECONDARY LH - Week 24 |
3; 4.1; 3.4; 6.4; 5; 7.7 | — |
| SECONDARY FSH - Screen |
2.7; 2.4; 5.5; 4.5; 3.3; 3.6 | — |
| SECONDARY FSH - Week 8 |
5.4; 4.3; 8.2; 16.2; 3.4; 4.1 | — |
| SECONDARY FSH - Week 16 |
7; 4.3; 4.2; 5.3; 10.7; 6.8 | — |
| SECONDARY FSH - Week 24 |
4.1; 4.8; 3; 5.2; 6.5; 4 | — |
| SECONDARY Free Testosterone - Screen |
8.4; 6.99; 7.28; 8.82; 6.27; 7.86 | — |
| SECONDARY Free Testosterone - Week 8 |
19.46; 21.8; 17.72; 35.27; 2.71; 12.3 | — |
| SECONDARY Free Testosterone - Week 16 |
14.16; 16.37; 12.27; 12.67; 19.21; 17.47 | — |
| SECONDARY Free Testosterone - Week 24 |
10.51; 19.35; 6.25; 11.28; 8.65; 19.31 | — |
| SECONDARY Estradiol - Screen |
21.6; 8.1; 9.6; 13.5; 15.9; 18.4 | — |
| SECONDARY Estradiol - Week 8 |
11.2; 49.8; 94.5; 20.8; 22.5; 7 | — |
| SECONDARY Estradiol - Week 16 |
39.5; 8.9; 17.9; 56.9; 5; 13.1 | — |
| SECONDARY Estradiol - Week 24 |
22.5; 43.9; 16.2; 9.5; 18.1; 41.1 | — |
| SECONDARY SHBG - Screen |
13.9; 35.2; 20; 31.7; 26.2; 24.1 | — |
| SECONDARY SHBG - Week 8 |
10; 38.2; 18.4; 29.8; 23.9; 21.6 | — |
| SECONDARY SHBG - Week 16 |
22.3; 35.5; 13.8; 16.4; 33.3; 17.7 | — |
| SECONDARY SHBG - Week 24 |
14.6; 41.8; 15.1; 25.2; 29.7; 23.6 | — |
| SECONDARY SEP #1-3 Cumulative - Screen |
— | — |
| SECONDARY SEP #1-3 Cumulative - Week 8 |
3; 3; 1; 1; 3; 4 | — |
| SECONDARY SEP #1-3 Cumulative - Week 16 |
2; 3; 1; 2; 3; 3 | — |
| SECONDARY SEP #1-3 Cumulative - Week 24 |
3; 3; 3; 2; 3; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Men age 18-70
- Baseline morning Testosterone 150-350 ng/dL x2
- leutenizing hormone (LH) 1.5-9.2 miU/mL, Follicle stimulation hormone (FSH) 1.6-8.0 miU/mL, Prolactin 4-15 ng/mL
- Positive Androgen Deficiency in the Aging Male (ADAM) score. A positive score is when an affirmative answer (''yes'') to either questions "Do you have a decreased sex drive/libido?" or "Are your erections less strong?" or any three other questions.10
- Body mass index (BMI) 7 and 30 grams (drink more than 2 beers per day OR more than 1 glass of wine or cocktail daily)
- Having started a new medication during the past three months which may interfere with the outcome measures of the study
- Polycythemia (HCT >52% )
- History of prostate specific antigen (PSA)> 4.0 ng/dl
- Hematocrit (HCT)< 36 %
- Liver function tests greater than 2 times upper normal limits or history of abnormal electrolytes, calcium or Parathyroid hormone without workup, at the discretion of the investigator.
- Previous hypogonadal treatment within last 3 months. -
Data sourced from ClinicalTrials.gov (NCT03933618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.