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Hormone Therapy

Transdermal Estrogen for Anorexia Nervosa

Phase 2
Recruiting
Led By Pouneh Fazeli, MD
Research Sponsored by Pouneh K. Fazeli, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female
19-45 years of age
Must not have
Personal history of venous or arterial clot
History of stroke or myocardial infarction
Timeline
Screening 3 days
Treatment 18 months
Follow Up 1 day

Summary

This trial looks at whether using estrogen can help with low bone mass in women with anorexia nervosa.

Who is the study for?
This trial is for adult women aged 19-45 with anorexia nervosa, specifically those who are underweight according to specific tables and have low bone mass. Participants must not be pregnant or planning pregnancy soon, should not have a history of certain blood or bone disorders, no recent use of medications affecting bone metabolism, and no severe illnesses like diabetes or untreated thyroid issues.
What is being tested?
The study is testing the effects of transdermal estrogen patches compared to placebo on improving bone density in women with anorexia nervosa. It's a randomized trial meaning participants will be randomly assigned to either the treatment group receiving estrogen or the control group receiving a placebo.
What are the potential side effects?
Potential side effects from transdermal estrogen may include skin irritation at the patch site, changes in mood or libido, headaches, nausea, menstrual irregularities for those not experiencing amenorrhea and possibly increased risk of blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am female.
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I am between 19 and 45 years old.
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I have been diagnosed with anorexia nervosa.
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I am female.
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I am between 19 and 45 years old.
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I have been diagnosed with anorexia nervosa.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a blood clot in my veins or arteries before.
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I have had a stroke or heart attack in the past.
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I have a history of blood clotting disorders.
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I or my close family member had breast cancer.
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I have a history of hereditary angioedema.
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I haven't taken any medications that affect bone health in the specified time frames.
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I have had a bone fracture in the last year.

Timeline

Screening ~ 3 days
Treatment ~ 18 months
Follow Up ~1 day
This trial's timeline: 3 days for screening, 18 months for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in bone mineral density at 18 months
Secondary study objectives
Structure of neck of femur
Change in bone mineral density at hip at 18 months
Change in estimated bone strength at 18 months
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Transdermal estrogen/progesteroneExperimental Treatment1 Intervention
Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) patch applied weekly for 18 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo patch applied weekly for 18 months

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Pouneh K. Fazeli, MDLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,820 Total Patients Enrolled
4 Trials studying Anorexia Nervosa
375 Patients Enrolled for Anorexia Nervosa
Pouneh Fazeli, MDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
90 Total Patients Enrolled

Media Library

Transdermal estrogen (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03875378 — Phase 2
Anorexia Nervosa Research Study Groups: Placebo, Transdermal estrogen/progesterone
Anorexia Nervosa Clinical Trial 2023: Transdermal estrogen Highlights & Side Effects. Trial Name: NCT03875378 — Phase 2
Transdermal estrogen (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03875378 — Phase 2
~13 spots leftby Nov 2025
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