Phase 2
N=35
Insulin Resistance and Testosterone in Women
Insulin Resistance · Postmenopause
Bottom Line
View on ClinicalTrials.gov: NCT00123110 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Percent Change in Free Testosterone (T) — -6.9; -35.8; 12.1 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- metformin (Drug); leuprolide injection (Drug); placebo pill (Drug); placebo injection (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- University of Pennsylvania
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Free Testosterone (T) |
-6.9; -35.8; 12.1 | — |
| PRIMARY Change in Insulin Sensitivity |
0.44; 0.04; -0.08 | — |
| SECONDARY Percent Change in Luteinizing Hormone (LH) From Baseline |
4.6; -96.5; -1.2 | — |
| SECONDARY Percent Change in Homeostasis Model Assessment Index of Insulin Resistance (HOMA-IR) |
-31.0; -8.18; 4.67 | — |
| SECONDARY Percent Change in Low Density Lipoprotein (LDL) |
-10.8; 5.3; 25.3 | — |
| SECONDARY Percent Change in Systolic Blood Pressure |
-4.2; 4.0; -0.3 | — |
| SECONDARY Free T and IR in Women in Whom Metabolic Syndrome is Present vs. Absent |
— | — |
| SECONDARY Dehydroepiandrosterone Sulfate (DHEA-S) |
2.6; 0.9; -2.9 | — |
| SECONDARY Body Mass Index (BMI) |
-1.3; 0.1; 0.3 | — |
Summary
The purpose of this research study is to determine if a relationship between insulin resistance (IR) and testosterone (T) exists in women who have already gone through menopause.
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women aged 50-79 years with absence of menses for 12 months; for women 50-54 years, Follicle stimulating hormone>30 U/mL to confirm postmenopausal status
- At least one intact ovary
- Free testosterone and fasting insulin levels within required study parameters
- Willing to comply with all study-related procedures
- Capable of giving informed consent
Exclusion Criteria
- History of cancer requiring treatment within the past 5 years (exceptions may be made by investigator)
- Hospitalization for treatment of vascular disease in the past 6 months
- Uncontrolled hypertension
- Hospitalization for chronic obstructive pulmonary disease or asthma in the past 3 months
- Use of continuous oxygen at home
- Surgery in the last 30 days
- Positive for HIV
- Abnormal blood tests (hemoglobin, fasting triglycerides, fasting glucose, creatinine, liver function)
- History of diabetes mellitus or use of any anti-hyperglycemic medication in the past 3 months
- Disease associated with disordered glucose metabolism (Cushing's disease, acromegaly, pheochromocytoma not surgically cured, chronic pancreatitis)
- History of chronic renal insufficiency
- Intravenous (IV) contrast studies with iodinated materials planned for the 12 week intervention period that cannot be postponed according to the participant's primary care provider
- Acute or chronic metabolic acidosis
- History of liver disease
- Congestive heart failure
- History of androgen-secreting tumors
- Hormone replacement therapy or antiandrogen use in past 6 months
- Use of dehydroepiandosterone (DHEA) or other androgen-containing products in past 6 months
- Corticosteroid use, other than topical, ophthalmic, intraarticular, and inhaled preparations, in past 3 months
- Undiagnosed current vaginal bleeding
- Excessive alcohol intake, either acute or chronic; current illicit substance abuse
- Participation in an investigational drug study within 6 weeks prior to screening visit
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study
Data sourced from ClinicalTrials.gov (NCT00123110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.