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Aromatase Inhibitors in the Treatment of Male Infertility

This study has been terminated.
(Not able meet target enrollment.)
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00440180
First received: February 22, 2007
Last updated: March 8, 2016
Last verified: March 2016

February 22, 2007
March 8, 2016
March 2007
June 2014   (final data collection date for primary outcome measure)
Pregnancy Rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Partner pregnancy rate during study participation
Sperm concentration
Complete list of historical versions of study NCT00440180 on ClinicalTrials.gov Archive Site
Not Provided
Other sperm parameters, hormonal measures and pregnancy rates
Not Provided
Not Provided
 
Aromatase Inhibitors in the Treatment of Male Infertility
The Role of Aromatase Inhibitors in the Treatment of Infertility in Obese Male
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Oligospermia
  • Drug: Anastrozole
    1 mg qd for 4 months
    Other Name: Arimidex
  • Drug: Placebo
    Placebo Comparator
  • Placebo Comparator: Group B
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Group A
    Anastrozole
    Intervention: Drug: Anastrozole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male partner of a couple presenting for infertility work up after one year of unprotected intercourse
  2. 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
  3. Obese men BMI ≥ 30
  4. FSH and LH levels < 10 mIU/mL

Exclusion Criteria:

  1. Severe Oligozoospermia: Sperm count < than 3 × 106/mL, including azoospermia
  2. Age less than 18 or greater than 65 years
  3. Pyospermia or leukospermia: defined by white blood cells ≥ 1 million leukocytes per milliliter of semen
  4. Cryptorchidism
  5. Vasectomy reversal
  6. Regular use of tobacco products
  7. BMI < 30
  8. Use of anabolic steroids or testosterone replacement
  9. All patients with abnormal initial liver function tests "AST or ALT" will be excluded form the study
Male
16 Years to 80 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00440180
IRB_00016246
Yes
Not Provided
Not Provided
University of Utah
University of Utah
Not Provided
Principal Investigator: Ahmad O Hammoud, MD University of Utah
University of Utah
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP