Health TrialsbyHealthPanel

Transdermal Estrogen in Women With Anorexia Nervosa

ConditionAnorexia Nervosa
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age19-45
SponsorPouneh K. Fazeli, MD

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transdermal estrogen

    Drug

    Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) weekly patch

  • Placebos

    Drug

    Placebo weekly patch

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Transdermal estrogen/progesteroneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in bone mineral density at 18 months

Change in lumbar spine bone mineral density at 18 months

Time frame
Baseline, 18 months

Secondary outcomes

1

Change in bone mineral density at hip at 18 months

Change in total hip bone mineral density at 18 months

Time frame
Baseline, 18 months
2

Change in bone mineral density at femoral neck at 18 months

Change in femoral neck bone mineral density at 18 months

Time frame
Baseline, 18 months
3

Change in parameters of bone microarchitecture at 18 months

Change in microarchitectural parameters as measured by high-resolution peripheral quantitative CT at 18 months

Time frame
Baseline, 18 months
4

Change in estimated bone strength at 18 months

Change in estimated bone strength as assessed by finite element analysis at 18 months

Time frame
Baseline, 18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pouneh K. Fazeli, MD

Lead sponsor

University of Pittsburgh

Sponsor institution

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
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