Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
Recruiting in Palo Alto (17 mi)
+16 other locations
GC
Overseen byGlenn Cunningham, MD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Repros Therapeutics Inc.
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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
Research Team
GC
Glenn Cunningham, MD
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
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
See 7 more
Treatment Details
Interventions
- Androxal (Selective Estrogen Receptor Modulator)
- Placebo ()
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Androxal 25 mgExperimental Treatment1 Intervention
25 mg/day
Group II: Androxal 12.5 mgExperimental Treatment1 Intervention
12.5 mg/day
Group III: PlaceboPlacebo Group1 Intervention
Placebo
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research Across AmericaCarrollton, TX
TX Urology AssociateHouston, TX
Lahey ClinicPeabody, MA
Dr. Rakesh PatelHouston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Repros Therapeutics Inc.
Lead Sponsor
Trials
59
Patients Recruited
3,800+