Hormonal Skin Patch for Women with Anorexia Nervosa

STUDY BASICS

Are you a 19-45 year old woman diagnosed with anorexia nervosa? You may be able to participate in a research study to help find out if a hormonal skin patch can improve bone density in women with anorexia nervosa. Participation involves imaging studies, blood tests, and nutritional analyses. Compensation is provided.

STUDY PURPOSE

Anorexia nervosa is an eating disorder that causes a person to eat very little and become extremely thin. Women who have anorexia nervosa can develop a variety of health complications, including significant bone loss that may lead to breaks and fractures. Bone loss in women with anorexia nervosa is caused by hormonal changes related to long-term nutritional deficiencies.

The purpose of the study is to find out if a hormonal skin patch called Climara Pro® can increase bone density in premenopausal women who have anorexia nervosa and bone loss. Climara Pro® is approved by the U.S. Food and Drug Administration (FDA) to treat bone loss and other symptoms in menopausal women, but is not approved to treat bone loss in women with anorexia nervosa.

COULD THIS STUDY BE RIGHT FOR YOU?

• Females ages 19-45
• Have anorexia nervosa
• Have low body weight
• Concerned about your bone health

WHAT PARTICIPANTS CAN EXPECT

Participation includes a screening visit, a baseline visit, four additional outpatient visits, and three 10 minute phone check-ins over the course of eighteen months. Eligible participants will be randomly assigned (like the flip of a coin) to receive either a hormonal skin patch called Climara Pro® or the placebo patch. The placebo patch does not contain any hormones.

Tests and assessments during the study include MRI scans, CT scans, DXA scans, physical exams, medical history, nutritional evaluations, questionnaires, blood draws, and urine samples.