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Sleep apnea testosterone study pulled before starting

NCT ID NCT01850992

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study was designed to understand how obstructive sleep apnea (OSA) speeds up the natural drop in testosterone as men age. Researchers planned to use CPAP machines—one real, one placebo—to test hormone changes in men aged 30 to 70 with moderate to severe OSA. However, the study was withdrawn before enrolling any participants, so no data or conclusions are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Start date

May 2013

Finished

Aug 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 70 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men aged 30-70 years * Moderate to severe OSA defined as an apnea hypopnea index (AHI) ≥20 events/h and an oxygen desaturation index 3% ≥15 events/h. * BMI of 30-35 kg/m2. * Stable weight over preceding 6 weeks * Not previously successfully treated with CPAP * Living in the community Exclusion Criteria: * Unable or unwilling to provide written Institutional Review Board (IRB) -approved informed consent. * Severe OSA requiring immediate CPAP treatment (severe OSA defined as AHI \>80 events/h or minimum oxygen saturation \<85% * Excessive sleepiness in relation to the subject's occupation which thereby increases their associated risk in the physician's judgement (e.g. truck driver or transport worker) * Sleepiness-related automobile accident in previous 12 months * Diabetes mellitus (historically or based on screening Hemoglobin A1c \>6.5%) * Patients with severe renal or hepatic impairment, in the judgement of the investigator. This may include patients with evidence of active liver disease (levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and/or alkaline phosphatase \>2x the upper limit of the normal range (ULN) and patients with impaired renal function as evidenced by a creatine value \> 1.2x ULN. * Any chronic medical conditions likely, in the judgment of the investigator, that makes the patient unable to complete the study safely, or otherwise unsuitable for the study or that may interfere with or influence study treatment. * Blood donation in the previous 8 weeks. * Shift workers or patients with an irregular sleep/wake routine. * Recent transmeridian travel (\>3 time zones in last 10 days). * Use of psychoactive medications (within 5 biological half-lives of enrollment) \[acetaminophen, laxatives, antacids, thiazide diuretics, ACE inhibitor, and ophthalmic or skin ointments are allowable\] * Recent or concurrent drug or alcohol abuse * Psychiatric illness under treatment * Anemia (hematocrit \< 38%) * Major organ-system disease (pulmonary, gastrointestinal, cardiac, hepatic, renal, endocrine, metabolic or hematological) * Acute or chronic inflammatory illness; AIDS and/or use of AIDS-related antiviral medications; profound fatigue or significant personal stress * Unoperated obstructive uropathy, recurrent prostatitis, indeterminate prostatic nodularity, history or suspicion of cancer of the prostate gland or screening serum prostatic specific antigen (PSA) concentration \> 4 ng/mL * Allergy to any proposed study medication * Other endocrine abnormalities including hypothyroidism or adrenal failure; primary gonadal disease as indicated by serum LH or follicle stimulating hormone (FSH) concentration \> 10 or \> - IU/L, respectively, hyperprolactinemia indicated by prolactin \> 25 μg/L * Administration of testosterone or anabolic steroids * Concurrent participation in another research study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • LA Biomedical Research Institute

    Torrance, California, 90502, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.