ObesityPhase 3NCT00440180
Aromatase Inhibitors in the Treatment of Male Infertility
A Phase 3 study testing Anastrozole in people with Obesity and Oligospermia, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years, men only
- Conditions the study is for
- Obesity, Oligospermia
- What is being tested?
- Anastrozole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jun 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity, Oligospermia
- Being tested
- Anastrozole, Placebo
- Keywords
- Obesity, Low sperm count, Male infertility
- Medical subject headings
- Obesity, Oligospermia, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Also called Arimidex
1 mg qd for 4 months
PlaceboDrug
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Group B | Placebo comparator | Placebo Receives: Drug: Placebo |
| Group A | Experimental | Anastrozole Receives: Drug: Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate
Partner pregnancy rate during study participation
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Not able meet target enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmad O Hammoud, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440180
- Sponsor's protocol ID
- IRB_00016246
- Status last verified
- Mar 2016
- First submitted
- 22 Feb 2007
- Last updated
- 6 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Aromatase Inhibitors in the Treatment of Infertility in Obese Male
- ClinicalTrials.gov ID
- NCT00440180
- Acronym / sponsor ID
- IRB_00016246
- Conditions
- Obesity, Oligospermia
- Keywords
- Obesity, Low sperm count, Male infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not able meet target enrollment.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Feb 2007 (estimated)
- Results
- Posted 7 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Placebo comparator | Drug: PlaceboPlacebo |
| Group A | Experimental | Drug: AnastrozoleAnastrozole |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnastrozoleAlso: Arimidex1 mg qd for 4 months | Drug | Group A |
| PlaceboPlacebo Comparator | Drug | Group B |
Primary outcome
Pregnancy Rate
Time frame: 4 months
Partner pregnancy rate during study participation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad O Hammoud, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anastrozole in people with Obesity and Oligospermia, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.