NCT03933618

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Albany Medical College · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypogonadism, Male

Interventions

Type	Name	Description
DRUG	Anastrozole 1mg
DRUG	Clomiphene Citrate 25mg
DRUG	Placebo - Cap

Timeline

• Start date: 2015-04-02
• Primary completion: 2017-03-08
• Completion: 2017-03-08
• First posted: 2019-05-01
• Last updated: 2019-11-18
• Results posted: 2019-11-18