Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabet… (NCT01191320) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
United States102 participantsStarted 2010-10
Plain-language summary
The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism
Who can participate
Age range
20 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males, ages 20 to 80-years-old, inclusive
* A diagnosis of type 2 diabetes mellitus by American Diabetes Association (ADA) criteria for at least 6 months
* Treatment with a stable but sub-optimum dose of OHAs for at least 2 months prior to screening based on a lack of control of blood glucose
* Previous diagnosis of adult-onset idiopathic hypogonadotropic hypogonadism (AIHH) and have undergone treatment with a topical testosterone gel, Low-to-borderline morning total testosterone (TT), after at least a two week wash-out period, and normal or low normal serum luteinizing hormone (LH)at screening and at baseline
* No previous diagnosis of AIHH but present as naïve patients with low morning TT and normal or low normal serum LH at screening and at baseline
* Body Mass Index (BMI) between 26 and 40 kg/m2
* Fasting blood (plasma or serum) glucose (FBG) between 125 and 240 mg/dL
* HemoglobinA1c in serum as (HbA1c) between 7% and 9.5%
* Comprehends informed consent
* Otherwise normal healthy males
* All clinical laboratory test within normal ranges (any deviation outside the normal range will require approval of investigator)
* Ability to complete the study in compliance with the protocol
* Ability to understand and provide written informed consent
Exclusion Criteria:
* A history of testicular failure, Kallmann Syndrome or other infertility condition
* Clinically significant medical condition rendering the subjects infertile including tumors of the pituitary,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.