At a glance
ClinicalIndex Comparison Record- ✓Women age 18-55
- ✓Hypopituitarism with documented central adrenal deficiency (by ITT or prior workup) and/or central gonadal deficiency (by amenorrhea/oligomenorrhea history and low FSH <5 MIU/mL or LHRH stimulation test)
- ✓Serum testosterone <20 ng/dL or free testosterone <1.5 pg/mL on transdermal estrogen replacement
- ✓Weight 80-150% of ideal body weight
- ✕Significant cardiopulmonary disease including prior myocardial infarction with ventricular dysfunction, angina, arrhythmias, congestive heart failure, or valvular problems
- ✕Venous thrombotic event (pulmonary embolism or deep vein thrombosis)
- ✕Renal disease with creatinine >1.5 mg/dL
- ✕Diabetes mellitus on insulin
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Physiologic Testosterone Replacement in Women With Hypopituitarism
In Brief
A Phase 4 clinical trial evaluating Transdermal Testosterone gel for Panhypopituitarism. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The principal aim of this study is to evaluate if application of testosterone gel leads to improvement in measures of sexual function, thinking ability and quality of life in women with dysfunction of the pituitary gland. A secondary purpose is to determine the effects of testosterone replacement on body composition and muscle function and strength.
Study Details
Timeline
Interventions
2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.