Aromatase Inhibitors in the Treatment of Male Infertility

NCT00440180 | Terminated Phase 3 Results DMC

• 1 other identifier: IRB_00016246
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is associated with an increase in blood levels of estrogen. Estrogen or "female hormone" is believed to have a negative effect on sperm production. Aromatase inhibitors such as anastrozole work to decrease the production of estrogen and increase testosterone in the body. By decreasing the level of estrogen, sperm production should improve. In this study, the investigators will try to determine the benefit of anastrozole in obese men and follow pregnancy outcomes.

Conditions

Obesity; Oligospermia

Keywords

Obesity; Low sperm count; Male infertility

Outcome Measures

Primary Outcomes (1)

• Pregnancy Rate

  Partner pregnancy rate during study participation

  4 months

Study Arms (2)

Group B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Group A

EXPERIMENTAL

Anastrozole

Drug: Anastrozole

Interventions

Anastrozole DRUG

1 mg qd for 4 months

Also known as: Arimidex

Group A

Placebo DRUG

Placebo Comparator

Group B

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male partner of a couple presenting for infertility work up after one year of unprotected intercourse
• Moderate oligozoospermia (defined as mean sperm count ≤ 20 × 106/mL and ≥ than 3 × 106/mL) of at least two separate occasions spanning a minimum of two weeks
• Obese men BMI ≥ 30
• FSH and LH levels \< 10 mIU/mL

You may not qualify if:

• Severe Oligozoospermia: Sperm count \< than 3 × 106/mL, including azoospermia
• Age less than 18 or greater than 65 years
• Pyospermia or leukospermia: defined by white blood cells ≥ 1 million leukocytes per milliliter of semen
• Cryptorchidism
• Vasectomy reversal
• Regular use of tobacco products
• BMI \< 30
• Use of anabolic steroids or testosterone replacement
• All patients with abnormal initial liver function tests "AST or ALT" will be excluded form the study

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Obesity; Oligospermia; Infertility, Male

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Marie Gibson
• Organization: University of Utah

marie.gibson@hsc.utah.edu

801-213-2845

Study Officials

• Ahmad O Hammoud, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 26, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 6, 2016
• Results First Posted: March 7, 2016

Record last verified: 2016-03

Locations

US (1)