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New treatment option for Anorexia Nervosa
Official title Transdermal Estrogen in Women With Anorexia Nervosa
ClinicalTrials.gov ID: NCT03875378
What this study is testing
What is Transdermal estrogen?
Transdermal estrogen is an investigational medicine, given as an once-weekly, being studied as a potential treatment for anorexia nervosa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 45, women only
You may be able to join if
- Female
- 19-45 years of age
- DSM-5 psychiatric criteria for anorexia nervosa
- \<85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables
- Amenorrhea
You likely can't join if
- Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or...
- Personal history of venous or arterial clot
- History of stroke or myocardial infarction
- History of hypercoagulable disorder
- Personal history or history of a first-degree relative with breast cancer
- History of hereditary angioedema
See the full eligibility criteria
- Female
- 19-45 years of age
- DSM-5 psychiatric criteria for anorexia nervosa
- \<85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables
- Amenorrhea
- T-score of \< -1.0 at spine or hip
- Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency (eGFR \< 60)
- Personal history of venous or arterial clot
- History of stroke or myocardial infarction
- 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...
- Bone fracture within the prior 12 months
- Serum potassium \ 3 times the upper limit of normal or Hemoglobin \< 10 g/dL
- Fasting serum triglyceride level \> 150 mg/dL
- Pregnant or breastfeeding (or desiring pregnancy within the next 18 months)
- Active substance abuse
- Elevated PTH level
- 25-OH vitamin D level \< 20 ng/mL
- Low phosphorus level
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 19 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.