Transdermal Estrogen in Women With Anorexia Nervosa

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Pouneh K. Fazeli, MD
Study ID
NCT03875378
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anorexia Nervosa

Eligibility Criteria

Sex
FEMALE
Age
19 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Transdermal estrogen — DRUG
    Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) weekly patch
  • Placebos — DRUG
    Placebo weekly patch

Study Details

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

Key Dates

Start date
Aug 28, 2020
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Transdermal estrogen/progesterone
    Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) patch applied weekly for 18 months
  • Placebo Comparator: Placebo
    Placebo patch applied weekly for 18 months

Primary Outcome Measure

Change in bone mineral density at 18 months [ Time Frame: Baseline, 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh School of MedicinePittsburghPennsylvania15213
Pouneh K Fazeli, MD
[email protected]
412-586-9700
Shari Reynolds

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University of Pittsburgh School of Medicine· Pittsburgh, PA

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