NCT03875378

Transdermal Estrogen in Women With Anorexia Nervosa

Transdermal Estrogen for the Treatment of Bone Loss in Women With Anorexia Nervosa

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Pouneh K. Fazeli, MD · Academic / Other
• Sex: Female
• Age: 19 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.

Detailed description

Anorexia nervosa is a prevalent psychiatric with a lifetime prevalence of up to 2.2%. Among the many medical co-morbidities associated with anorexia nervosa, the most common is significant bone loss, which can persist despite weight recovery. Nearly 90% of women with anorexia nervosa have osteopenia and this low bone mass is associated with an increased fracture risk. Nearly 30% of women with anorexia nervosa report a history of a fracture and a prospective study demonstrated a 7-fold increased risk of fracture in women with anorexia nervosa compared to age-matched controls. Because anorexia nervosa is a chronic disease that can persist despite psychiatric and nutritional counseling, the bone loss and increased fracture risk can persist and lead to lifelong morbidity. Therefore, finding a treatment for bone loss associated with anorexia nervosa is of critical importance. This 18-month randomized, placebo-controlled study will investigate in women (ages 20 to 45 years old) with anorexia nervosa whether treatment with transdermal estrogen replacement will increase bone mineral density (BMD).

Conditions

• Anorexia Nervosa

Interventions

Type	Name	Description
DRUG	Transdermal estrogen	Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) weekly patch
DRUG	Placebos	Placebo weekly patch

Timeline

• Start date: 2020-08-28
• Primary completion: 2028-08-31
• Completion: 2028-12-31
• First posted: 2019-03-14
• Last updated: 2025-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study