Anorexia NervosaPhase 2NCT03875378
Transdermal Estrogen in Women With Anorexia Nervosa
A Phase 2 study testing Transdermal estrogen in people with Anorexia Nervosa, run by Pouneh K. Fazeli, MD at 1 site in United States.
Trial summary
Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Transdermal estrogen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2020to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
- Bone fracture within the prior 12 months
- Serum potassium < 3.0 meq/L, serum ALT > 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shari Reynolds contact
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
Pouneh K Fazeli, MD, 412-586-9700, pkfazeli@pitt.edu
Shari Reynolds
About this study
Official title: Transdermal Estrogen for the Treatment of Bone Loss in Women With Anorexia Nervosa
Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.
Read the detailed description
Anorexia nervosa is a prevalent psychiatric with a lifetime prevalence of up to 2.2%. Among the many medical co-morbidities associated with anorexia nervosa, the most common is significant bone loss, which can persist despite weight recovery. Nearly 90% of women with anorexia nervosa have osteopenia and this low bone mass is associated with an increased fracture risk. Nearly 30% of women with anorexia nervosa report a history of a fracture and a prospective study demonstrated a 7-fold increased risk of fracture in women with anorexia nervosa compared to age-matched controls. Because anorexia nervosa is a chronic disease that can persist despite psychiatric and nutritional counseling, the bone loss and increased fracture risk can persist and lead to lifelong morbidity. Therefore, finding a treatment for bone loss associated with anorexia nervosa is of critical importance.
This 18-month randomized, placebo-controlled study will investigate in women (ages 20 to 45 years old) with anorexia nervosa whether treatment with transdermal estrogen replacement will increase bone mineral density (BMD).
- Conditions
- Anorexia Nervosa
- Being tested
- Transdermal estrogen, Placebos
- Keywords
- Bone mineral density, Estrogen
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal estrogenDrug
Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) weekly patch
PlacebosDrug
Placebo weekly patch
| Study group | Role | What they receive |
|---|---|---|
| Transdermal estrogen/progesterone | Experimental | Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) patch applied weekly for 18 months Receives: Drug: Transdermal estrogen |
| Placebo | Placebo comparator | Placebo patch applied weekly for 18 months Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone mineral density at 18 months
Change in lumbar spine bone mineral density at 18 months
Measured: Baseline, 18 months
Secondary outcomes (5)
Change in bone mineral density at hip at 18 months
Change in total hip bone mineral density at 18 months
Measured: Baseline, 18 months
Change in bone mineral density at femoral neck at 18 months
Change in femoral neck bone mineral density at 18 months
Measured: Baseline, 18 months
Change in parameters of bone microarchitecture at 18 months
Change in microarchitectural parameters as measured by high-resolution peripheral quantitative CT at 18 months
Measured: Baseline, 18 months
Change in estimated bone strength at 18 months
Change in estimated bone strength as assessed by finite element analysis at 18 months
Measured: Baseline, 18 months
Change in vertebral fractures at 18 months
Change in vertebral fractures as assessed by vertebral fracture assessment at 18 months
Measured: Baseline, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start28 Aug 2020
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pouneh K. Fazeli, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Pouneh K. Fazeli, MD, University of Pittsburgh
- Investigators
- Pouneh Fazeli, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875378
- Sponsor's protocol ID
- STUDY19070395
- Other IDs
- R01HD099139
- Status last verified
- May 2026
- First submitted
- 11 Mar 2019
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will include self-reported demographic and behavioral data from interviews with the subjects, laboratory data from blood specimens provided and radiologic images of subjects with anorexia nervosa. Because anorexia nervosa is a psychiatric disease and we will be collecting identifying information, even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that the information disclosed by the subjects should be protected in the most stringent way possible in order to prevent possible identification of subjects. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: 1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Estrogen for the Treatment of Bone Loss in Women With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT03875378
- Acronym / sponsor ID
- STUDY19070395
- Conditions
- Anorexia Nervosa
- Keywords
- Bone mineral density, Estrogen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Pouneh K. Fazeli, MDUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.
Detailed description
Anorexia nervosa is a prevalent psychiatric with a lifetime prevalence of up to 2.2%. Among the many medical co-morbidities associated with anorexia nervosa, the most common is significant bone loss, which can persist despite weight recovery. Nearly 90% of women with anorexia nervosa have osteopenia and this low bone mass is associated with an increased fracture risk. Nearly 30% of women with anorexia nervosa report a history of a fracture and a prospective study demonstrated a 7-fold increased risk of fracture in women with anorexia nervosa compared to age-matched controls. Because anorexia nervosa is a chronic disease that can persist despite psychiatric and nutritional counseling, the bone loss and increased fracture risk can persist and lead to lifelong morbidity. Therefore, finding a treatment for bone loss associated with anorexia nervosa is of critical importance.
This 18-month randomized, placebo-controlled study will investigate in women (ages 20 to 45 years old) with anorexia nervosa whether treatment with transdermal estrogen replacement will increase bone mineral density (BMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Transdermal estrogen/progesterone | Experimental | Drug: Transdermal estrogenTransdermal estradiol (0.045mg)/levonorgestrel (0.015mg) patch applied weekly for 18 months |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo patch applied weekly for 18 months |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal estrogenTransdermal estradiol (0.045mg)/levonorgestrel (0.015mg) weekly patch | Drug | Transdermal estrogen/progesterone |
| PlacebosPlacebo weekly patch | Drug | Placebo |
Primary outcome
Change in bone mineral density at 18 months
Time frame: Baseline, 18 months
Change in lumbar spine bone mineral density at 18 months
5 secondary outcomes
Change in bone mineral density at hip at 18 months
Time frame: Baseline, 18 months
Change in bone mineral density at femoral neck at 18 months
Time frame: Baseline, 18 months
Change in parameters of bone microarchitecture at 18 months
Time frame: Baseline, 18 months
Change in estimated bone strength at 18 months
Time frame: Baseline, 18 months
Change in vertebral fractures at 18 months
Time frame: Baseline, 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Yes. The final dataset will include self-reported demographic and behavioral data from interviews with the subjects, laboratory data from blood specimens provided and radiologic images of subjects with anorexia nervosa. Because anorexia nervosa is a psychiatric disease and we will be collecting identifying information, even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that the information disclosed by the subjects should be protected in the most stringent way possible in order to prevent possible identification of subjects. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: 1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shari Reynolds contact
Pouneh Fazeli, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transdermal estrogen in people with Anorexia Nervosa, run by Pouneh K. Fazeli, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pouneh Fazeli, MD (412-586-9700, pkfazeli@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone mineral density at 18 months (time frame: Baseline, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.