Baseline Sexual Function, Cognitive Function, Body Composition and Muscle Parameters and Pharmacokinetics of Transdermal Testosterone Gel in Women With Hypopituitarism

NCT00144404 | Withdrawn DMC

• 1 other identifier: 02-04-376-07
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the blood levels of testosterone gel administered for a week to women with hypopituitarism and determine if this leads to testosterone replacement in a normal range for women. An additional objective is to determine the baseline laboratory abnormalities and physical, brain function, emotional and sexual symptomatology of these women with hypopituitarism.

Conditions

Panhypopituitarism

Outcome Measures

Primary Outcomes (1)

• The purpose of this study is to determine the pharmacokinetics of testosterone gel 2 mg/d administered for a week to women with hypopituitarism and determine if this leads to testosterone replacement in a physiologic range.

  6 weeks

Secondary Outcomes (1)

• An additional objective is to determine the baseline laboratory abnormalities and physical, cognitive, emotional and sexual symptomatology of these women with hypopituitarism.

  6 weeks

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women age 18-55
• Hypopituitarism with documented central adrenal and gonadal deficiencies. Serum testosterone level of \< 20 ng/dl or free testosterone \<1.5 pg/ml on conjugated equine estrogen replacement
• No other significant medical condition
• Weight between 80 and 150% of ideal body weight
• Able to provide informed consent
• All races and ethnicities
• All patients regardless of marital status and relationship status

You may not qualify if:

• Physical disabilities that would prevent them from participating in the study
• Current use of testosterone or other androgenic steroids. Patients who are taking testosterone, DHEA or other androgen precursors will discontinue these medications/supplements three months prior to the study.
• Significant cardiopulmonary disease, renal disease (creatinine \> 1.5 mg/dL), diabetes mellitus, uncontrolled hypertension, malignancy (other than basal cell skin carcinoma) or major psychiatric disease. Patients with depression or anxiety on a stable dose of medication will be allowed to enroll.
• Current abuse of illicit drugs or heavy ethanol use
• History of breast or uterine cancer
• Those with significant liver function abnormalities defined as SGOT, SGPT or alkaline phosphatase value of greater than one and one-half times the upper limit of normal in our Clinical Pathology Laboratory or serum bilirubin levels of greater than 2 mg/dl will be excluded.
• Those with history of hyperandrogenic disorders such as hirsutism and polycystic ovary disease will be excluded. These conditions are rare in women with hypopituitarism. Testosterone administration to these patients may exacerbate the underlying disorder.
• Women who are pregnant, seeking to become pregnant in the next 6 months, or breast feeding
• Those who have previously experienced intolerance to other transdermal systems
• Drugs known to alter testosterone production such as Megace or ketoconazole
• Patients with untreated hyperprolactinemia or active Cushing's disease. Patients with treated prolactinoma or Cushing's disease will be allowed to participate in the study.
• Hematocrit \> 50%
• Male sex
• Not willing to answer all questions on surveys

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead

Study Sites (1)

Charles R. Drew University

Los Angeles, California, 90059, United States

Location

Related Links

• Clinical Trial Research site

MeSH Terms

Conditions

Combined Pituitary Hormone Deficiency

Study Officials

• Ted C Friedman, M.D., Ph.D.

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: August 1, 2002
• Primary Completion: August 1, 2002
• Study Completion: August 1, 2002
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

US (1)