NCT00027430

Brief Summary

This is a study to determine whether testosterone replacement with TheraDerm can improve bone density, mood, sex drive, thinking, and distribution of body fat and muscle mass in women with hypopituitarism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2001

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

March 25, 2015

Status Verified

November 1, 2001

First QC Date

December 5, 2001

Last Update Submit

March 24, 2015

Conditions

Hypopituitarism

Interventions

TheraDermDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hypogonadism and/or hypoadrenalism of central origin
  • Testosterone or free testosterone level below the median for age-matched normal controls
  • Prior estrogen preparation for at least 6 months

You may not qualify if:

  • Any disease known to affect bone metabolism, including untreated hypothyroidism or hyperthyroidism
  • Change in thyroid hormone dose in the last 3 months
  • Untreated Cushing's syndrome
  • Renal failure
  • Alcoholism
  • Anorexia nervosa
  • Prior use of medication known to affect bone metabolism (e.g., supraphysiologic doses of glucocorticoids, phenytoin, bisphosphonates, or calcitonin) within the past 3 months
  • Pregnant or nursing
  • Uncontrolled hypertension
  • ALT greater than 3 times upper limit of normal
  • Serum creatinine greater than 2 times the upper limit of normal
  • Any contraindication to estrogen therapy, including history of breast cancer or undiagnosed uterine bleeding
  • Concurrent growth hormone replacement therapy, if patient has been receiving it for less than 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Lin E, McCabe E, Newton-Cheh C, Bloch K, Buys E, Wang T, Miller KK. Effects of transdermal testosterone on natriuretic peptide levels in women: a randomized placebo-controlled pilot study. Fertil Steril. 2012 Feb;97(2):489-93. doi: 10.1016/j.fertnstert.2011.11.001. Epub 2011 Dec 2.

    PMID: 22137497DERIVED

MeSH Terms

Conditions

Hypopituitarism

Condition Hierarchy (Ancestors)

Pituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Anne Klibanski, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2001

First Posted

December 7, 2001

Study Start

September 1, 2001

Study Completion

December 1, 2004

Last Updated

March 25, 2015

Record last verified: 2001-11

Locations

US(1)