Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function

NCT03933618 | Completed Phase 2 Results

• 1 other identifier: 4134
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypogonadism, Male

Outcome Measures

Primary Outcomes (4)

• 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

  At baseline

• 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

  Week 8

• 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

  Week 16

• 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

  Week 24

Secondary Outcomes (36)

• Normalized Testosterone - Screen

  Baseline

• Normalized Testosterone - Week 8

  Week 8

• Normalized Testosterone - Week 16

  Week 16

• Normalized Testosterone - Week 24

  Week 24

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

  Baseline

Study Arms (6)

anastrazole-clomiphene-placebo

OTHER

anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks

Drug: Anastrozole 1mg; Drug: Clomiphene Citrate 25mg; Drug: Placebo - Cap

anastrazole-placebo-clomiphene

OTHER

anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks

Drug: Anastrozole 1mg; Drug: Clomiphene Citrate 25mg; Drug: Placebo - Cap

clomiphene-anastrazole-placebo

OTHER

clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks

Drug: Anastrozole 1mg; Drug: Clomiphene Citrate 25mg; Drug: Placebo - Cap

clomiphene-placebo-anastrazole

OTHER

clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks

Drug: Anastrozole 1mg; Drug: Clomiphene Citrate 25mg; Drug: Placebo - Cap

placebo-clomiphene-anastrazole

OTHER

placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks

Drug: Anastrozole 1mg; Drug: Clomiphene Citrate 25mg; Drug: Placebo - Cap

placebo-anastrazole-clomiphene

OTHER

placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks

Drug: Anastrozole 1mg; Drug: Clomiphene Citrate 25mg; Drug: Placebo - Cap

Interventions

Anastrozole 1mg DRUG

anastrazole-clomiphene-placebo; anastrazole-placebo-clomiphene; clomiphene-anastrazole-placebo; clomiphene-placebo-anastrazole; placebo-anastrazole-clomiphene; placebo-clomiphene-anastrazole

Clomiphene Citrate 25mg DRUG

anastrazole-clomiphene-placebo; anastrazole-placebo-clomiphene; clomiphene-anastrazole-placebo; clomiphene-placebo-anastrazole; placebo-anastrazole-clomiphene; placebo-clomiphene-anastrazole

Placebo - Cap DRUG

anastrazole-clomiphene-placebo; anastrazole-placebo-clomiphene; clomiphene-anastrazole-placebo; clomiphene-placebo-anastrazole; placebo-anastrazole-clomiphene; placebo-clomiphene-anastrazole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men age 18-70
• Baseline morning Testosterone 150-350 ng/dL x2
• leutenizing hormone (LH) 1.5-9.2 miU/mL, Follicle stimulation hormone (FSH) 1.6-8.0 miU/mL, Prolactin 4-15 ng/mL
• Positive Androgen Deficiency in the Aging Male (ADAM) score. A positive score is when an affirmative answer (''yes'') to either questions "Do you have a decreased sex drive/libido?" or "Are your erections less strong?" or any three other questions.10
• Body mass index (BMI) \<40
• Sexual health inventory for men (SHIM) score \>7 and \<21. Patients are allowed to be taking phosphodiesterase 5 inhibitors (i.e. Viagra, Levitra, Cialis) at baseline, however we will ask them to do the SHIM survey as if they were not taking this medication.
• Men must attempt to have at least four sexual encounters over each of the eight-week periods
• Men willing not to take phosphodiesterase 5 inhibitors throughout the entire study

You may not qualify if:

• Current or previous history of prostate cancer
• Previous or current androgen deprivation therapy for prostate cancer,
• Past surgical history of prostatectomy.
• History of testicular cancer.
• History of deep vein thrombosis (DVT) or blood dyscrasia
• History of breast cancer
• Men with past or current treatment for erectile dysfunction including MUSE (alprostodil), intracavernosal injections, penile prosthesis. Men not on treatment or men who are on phosphodiesterase inhibitors will be allowed to be in the study but must stop their use at the screening visit.
• Chronic opioid use
• Use of steroids within the past 3 months, including prednisone and/or cortisone injections, and inhaled steroids. Topical steroid cream is acceptable.
• History of or current use of anabolic steroids, i.e. testosterone, (or any analog of testosterone) dihydroepiandrosterone (DHEA), dihydroepiandrosterone sulfate (DHEAS) or any growth promoters i.e. growth hormone itself or analogs of growth hormone
• History of or current use of anti-androgen medications, i.e. Aldactone, Tagamet, estrogens
• Alcohol intake \> 30 grams (drink more than 2 beers per day OR more than 1 glass of wine or cocktail daily)
• Having started a new medication during the past three months which may interfere with the outcome measures of the study
• Polycythemia (HCT \>52% )
• History of prostate specific antigen (PSA)\> 4.0 ng/dl

Sponsors & Collaborators

• Albany Medical College: lead
• Laboratory Corporation of America: collaborator

MeSH Terms

Conditions

Eunuchism

Interventions

Anastrozole; Clomiphene

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Charles Welliver
• Organization: Albany Medical Center

wellivr@amc.edu

518-262-3341

Study Officials

• Robert C Welliver, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Study Start: April 2, 2015
• Primary Completion: March 8, 2017
• Study Completion: March 8, 2017
• Last Updated: November 18, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-10