Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa

NCT02475265 | Completed Phase 2 Results

• 2 other identifiers: 2015P000463R03DK106410
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength. This study will investigate whether the use of transdermal estrogen can improve bone mineral density (BMD) and bone microarchitecture in women with anorexia nervosa anorexia nervosa when used for 6 months.

Conditions

Anorexia Nervosa; Osteoporosis

Keywords

Anorexia Nervosa; Osteoporosis; Eating Disorder; Disordered Eating; Estrogen; Bone

Outcome Measures

Primary Outcomes (1)

• Percent Change in Bone Mineral Density (BMD) of Lumbar Spine by Dual Energy X-ray Absorptiometry (DXA)

  Percent change in lumbar spine bone mineral density after six-months. Lumbar spine bone mineral density measured by dual energy x-ray absorptiometry.

  6 months

Study Arms (1)

estradiol 0.045mg/levonorgestrel 0.015mg

EXPERIMENTAL

6 months of estradiol 0.045mg/levonorgestrel 0.015mg (once weekly patch).

Drug: estradiol 0.045 mg/levonorgestrel 0.015mg

Interventions

estradiol 0.045 mg/levonorgestrel 0.015mg DRUG

Also known as: Climara Pro transdermal patch

estradiol 0.045mg/levonorgestrel 0.015mg

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female; ages 25-50 years
• Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) psychiatric criteria for AN, including \<85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables, and amenorrhea
• T-score of \< -1.5 at spine or hip
• Treatment team or treatment professional in place for clinical treatment/monitoring during the study

You may not qualify if:

• Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency
• Personal history of venous or arterial clot
• History of stroke or myocardial infarction
• History of migraine headaches
• History of hypercoagulable disorder
• Personal history or history of a first-degree relative with breast cancer
• History of hereditary angioedema
• Any medication known to affect bone metabolism, including systemic glucocorticoids within three months of the baseline visit, depot medroxyprogesterone within 6 months of the baseline visit, oral bisphosphonates within one year of the baseline visit or intravenous (IV) bisphosphonates within three years of the baseline visit
• Bone fracture within the prior 12 months
• Serum potassium \< 3.0 meq/L or serum alanine aminotransferase (ALT) \> 3 times the upper limit of normal
• Fasting serum triglyceride level \> 150 mg/dL
• Pregnant or breastfeeding
• Active substance abuse

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa; Osteoporosis; Feeding and Eating Disorders

Interventions

Estradiol; Levonorgestrel

Condition Hierarchy (Ancestors)

Mental Disorders; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norgestrel; Norpregnenes; Norpregnanes; Norsteroids

Results Point of Contact

• Title: Dr. Pouneh Fazeli
• Organization: Massachusetts General Hospital

pkfazeli@partners.org

617-726-3870

Study Officials

• Pouneh K Fazeli, MD

  MGH/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 18, 2015
• Study Start: July 1, 2015
• Primary Completion: June 27, 2018
• Study Completion: July 30, 2018
• Last Updated: July 22, 2019
• Results First Posted: July 22, 2019

Record last verified: 2019-07

Locations

US (1)