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Androgen Replacement Therapy, Hypopit Women

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Summary: Androgen Replacement Therapy in Women with Hypopituitarism


This is a 12-month study investigating the effects of a natural hormone on bone formation, body composition, quality of life, cognitive function and libido. The study involves blood sampling, questionnaires and tests to determine bone density and the amount of fat and muscle in the body. Subjects will receive up to $600 for 6 outpatient visits after a screening visit determines eligibility.


Patient Inclusion/Exclusion Criteria:


Women ages 18-50 with adrenal insufficiency and/or estrogen deficiency from pituitary problems.





Karen Miller MD

Massachusetts General Hospital

Fruit Street


Boston, MA 02115

Telephone: 617-724-7388

Email: kkmiller@partners.org  



Center Overview

The Massachusetts General Hospital has a long, rich, and diverse tradition of excellence in clinical research that continues to expand today. The extensive resources for training clinical investigators and performing top quality translational investigation include: An integrated full service primary, secondary, and tertiary care hospital network with access to large numbers of both local patients with common diseases and national and international patients referred for evaluation of rare disorders, over 600,000 square feet of research space, and a diverse population of thousands of basic and clinical scientists studying topics ranging from very basic molecular biology to direct patient management.


The MGH Clinical Research Program (CRP) was established to improve the environment for clinical investigation at the MGH through academic enrichment programs and direct support services, creating a culture in which all forms of clinical research can flourish. Its mandate is to:



Enhance bench to bedside research

Train clinical investigators

Increase clinical trial activity

Support outcomes research and disease management

Coordinate the MGH's efforts with those of Partners HealthCare System and Harvard Medical School

The CRP serves as the institutional infrastructure that encourages and supports its physician scientists by serving as an interface between clinical investigators and sponsors of clinical trials and outcomes research. We work to:



Explore preferred relationships with pharmaceutical and biotech companies

Link industry to physicians for consulting, advisory board seats, and trials

Provide outcomes and disease management expertise

Support the administration of clinical trials

Negotiate master clinical trial agreements

The CRP provides a high level of clinical trial services to help investigators compete and meet the demands on industrial sponsors. Services to PIs include:



Assistance with the IRB application

Preparation and negotiation of budgets

Contact facilitation

Assistance in patient recruitment

Data management support

Assistance with strategy and proposal development for corporate-sponsored and investigator-initiated clinical trials

Assistance with the development of large multi-center grant applications

In addition to its role as a facilitator, the CRP has developed and sponsored a series of educational courses and seminars for current and future investigators and study coordinators. These activities not only improve the quality of the investigators and study coordinators but also raise awareness within the institution about clinical research. Mentoring is available to young researchers by fostering collaborations with established investigators. New investigators are offered career advice and assistance in developing and conducting research studies.


Since communication plays a critical role within the research community, the CRP has developed an interrelated set of communication and clinical research tools: CRnet an on-line information source about clinical research at MGH; web-based query tools and patient data registries to characterize patient populations and assess clinical trial feasibility; software and databases for investigator-initiated patient data registries and disease management studies; and direct technical support for the clinical investigative community.


The Clinical Research Program provides the infrastructure necessary to support clinical research on an institution-wide basis. By fostering academic collaboration, effecting communication with industrial sponsors and promoting a focused and streamlined administrative process, the CRP is building a responsive culture conducive to clinical investigation.

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