Recruiting
Phase 2

Transdermal Estrogen

Sponsor:

Pouneh K. Fazeli, MD

Code:

NCT03875378

Conditions

Anorexia Nervosa

Eligibility Criteria

Sex: Female

Age: 19 - 45

Healthy Volunteers: Not accepted

Interventions

Transdermal estrogen

Placebos

Study Details

Brief summary:

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

Conditions

Anorexia Nervosa

Study ID

NCT03875378

Start date

Aug 28, 2020

Status verified date

May, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Female
2. 19-45 years of age
3. DSM-5 psychiatric criteria for anorexia nervosa
4. <85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables
5. Amenorrhea
6. T-score of < -1.0 at spine or hip

Exclusion Criteria:

1. Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency (eGFR < 60)
2. Personal history of venous or arterial clot
3. History of stroke or myocardial infarction
4. History of hypercoagulable disorder
5. Personal history or history of a first-degree relative with breast cancer
6. History of hereditary angioedema
7. 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 one year of the baseline visit or IV bisphosphonates within three years of the baseline visit
8. Bone fracture within the prior 12 months
9. Serum potassium < 3.0 meq/L, serum ALT > 3 times the upper limit of normal or Hemoglobin < 10 g/dL
10. Fasting serum triglyceride level > 150 mg/dL
11. Pregnant or breastfeeding (or desiring pregnancy within the next 18 months)
12. Active substance abuse
13. Elevated PTH level
14. 25-OH vitamin D level < 20 ng/mL
15. Low phosphorus level

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Transdermal estrogen

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

Placebos

Placebo weekly patch

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Pittsburgh School of Medicine

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

More Information

Sponsor

Pouneh K. Fazeli, MD

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • Bone mineral density
  • Estrogen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pouneh K. Fazeli, MD on 2026-05-18.