Estradiol Hemihydrate Transdermal System for Anorexia Nervosa

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Royal University Hospital, Saskatoon, Canada
Anorexia Nervosa+1 More
Estradiol Hemihydrate Transdermal System - Drug
Eligibility
< 65
Female
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Study Summary

This study is evaluating whether a patch of estrogen can improve bone health in adolescents with anorexia nervosa.

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Eligible Conditions

  • Anorexia Nervosa

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Estradiol Hemihydrate Transdermal System will improve 1 primary outcome and 5 secondary outcomes in patients with Anorexia Nervosa. Measurement will happen over the course of Change from Baseline to Month 24.

Month 24
Areal Bone Content
Bone Micro-architectural Parameters
Bone Strength Estimates
Cortical Wall Thickness
Vertebral Fracture Rates
Volumetric Bone Density

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

No Treatment
1 of 2
Treatment
1 of 2
Active Control
Experimental Treatment

This trial requires 24 total participants across 2 different treatment groups

This trial involves 2 different treatments. Estradiol Hemihydrate Transdermal System is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Treatment
Drug
Participants randomized to the treatment arm will be divided by maturational status: Participants who have had their first period or have a bone age greater than or equal to 14 years will receive PrClimara® 25 (estradiol hemihydrate transdermal system - 25 mcg/day) as a weekly patch, for 24 months. o These participants will also receive progesterone (Provera 10 mg tablet) orally every 4 weeks, for 7 days during the second half of the planned menstrual cycle, in order to induce a menstrual period. Participants who have not yet had their first period and have a bone age below 14 years will receive an increasing dose of estrogen. These participants will be initiated on graduated dose of transdermal 17-β estradiol patches: 3.1 mcg/day (1/8 patch) for first six-months, 6.2 mcg/day (1/4 patch) for second six-months, 12.5 mcg/day (1/2 patch) for third six-months, and 25 mcg/day (full patch) for final six-months.
No TreatmentThe participants in this group will not receive the estrogen patch nor the oral progesterone.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to month 24
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline to month 24 for reporting.

Who is running the study

Principal Investigator
M. N.
Munier Nour, Principal Investigator
University of Saskatchewan

Closest Location

Royal University Hospital - Saskatoon, Canada

Eligibility Criteria

This trial is for female patients aged 65 and younger. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Female
Age 12 - 19 years old
Meet DSM-5 criteria for Anorexia Nervosa
o Criteria includes: persistent restriction of energy intake leading to significantly low body weight; either an intense fear of gaining weight or persistent behavior that interferes with weight gain; and a disturbance in the way one's body weight or shape is experienced
Amenorrhea for at least three months
Amenorrhea is a required inclusion criteria as participants with intact menstruation do not meet justification for estrogen replacement (as they are not estrogen deficient)
Participants will have been seen and assessed by anorexia clinic physician prior to enrollment to exclude and treat other causes of amenorrhea
Agree to use a highly effective contraceptive method for the duration of study therapy.

Patient Q&A Section

What is anorexia nervosa?

"Anorexia nervosa is a condition that is characterized by a decreased food consumption in which the patient loses a sense of fat or weight, or both. The decreased food intake can be continuous or intermittent. In the first case, the food intake is reduced in relation to the patient's energy requirements resulting in wasting (a symptom), which can lead to a reduced body weight. In the second case, intermittent food intake is usually associated with rebound weight that can occur when there is an interruption in eating. It may also occur in conjunction with bulimia nervosa that is characterized by binge eating and laxatives use. Both anorexia nervosa and bulimia nervosa are linked to depression." - Anonymous Online Contributor

Unverified Answer

What are common treatments for anorexia nervosa?

"Common treatments for anorexia nervosa include psychiatric medications and supportive treatments, most often from an inpatient setting. Most therapies for anorexia nervosa involve various forms of psychotherapy, with an emphasis on psychoeducation, changing attitudes toward anorexia nervosa and promoting interpersonal and social integration. Other common treatment approaches include the antidepressant fluoxetine, tricyclic antidepressants, and antipsychotic medications. Other less commonly used treatments include antipyretics and antiparasitics, as well as psychosocial and cognitive behavioral therapy." - Anonymous Online Contributor

Unverified Answer

What are the signs of anorexia nervosa?

"A negative weight-threshold for AN is not a sign of AN. Rather, these patients are often undernourished, exhibit binge eating and exhibit restrictive behaviours. Most patients experience multiple severe health problems before the onset of AN. Although the precise causes are not known, the increased mortality and morbidity rate seen in patients with AN is very challenging. This article is highlighted for its focus on the physical signs and symptoms of AN." - Anonymous Online Contributor

Unverified Answer

Can anorexia nervosa be cured?

"With good treatment, many people with anorexia can recover from the illness and lead a normal life. However, more than one-third of individuals with anorexia do not recover from the disorder. Many people with anorexia do not seek treatment as a result of concern about how their behaviour may impact their relationships with family and friends. Those people who have untreated anorexia do not experience symptomatic improvements." - Anonymous Online Contributor

Unverified Answer

How many people get anorexia nervosa a year in the United States?

"One patient out of every 5,000 women is diagnosed with anorexia nervosa. About 19,000 people develop anorexia nervosa each year. The average recovery duration for anorexia nervosa is 1.7 years, with an average of 2.1 years since diagnosis." - Anonymous Online Contributor

Unverified Answer

What causes anorexia nervosa?

"Our information showed that childhood sexual abuse (both non-consensual and consensual), a female-bodied objectification, a lack of parental interest in the child and body and eating disorders may be part of anorexia's etiology." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in estradiol hemihydrate transdermal system for therapeutic use?

"E2(H) is an effective dosage form for TES for a relatively long duration. These transdermal systems could be used in patients with moderate-to-severe symptoms of TES." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of estradiol hemihydrate transdermal system?

"The common side effects of E(2) HX transdermal system were nausea, headache/migraine, dizziness, edema of the mouth/throat and chest, breast tenderness, abdominal pain, vomiting and pruritus. These side effects and their severity are comparable with those reported in the peer-reviewed medical literature." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets anorexia nervosa?

"The number presenting for care during the course of study was low, limiting the power of this analysis. In a recent study, findings indicate that the average age of first referral for AN in this outpatient sample is about 21 years. There has been increased detection of AN, which may be due to a growing public awareness, increased healthcare spending on these patients and increased interest in eating disorders in the media. Thus an awareness and understanding of AN will hopefully reduce the number of people seeking help." - Anonymous Online Contributor

Unverified Answer

What is the latest research for anorexia nervosa?

"The most recent results of recent research of anorexia nervosa involve cognitive and emotional processing of body stimuli. Research on this area of cognition is being investigated to create more effective interventions. The study of emotion and body processing in anorexia nervosa has implications for a better understanding of other psychiatric diseases. Research studies that focus on the etiology and pathogenesis of anorexia nervosa have shown a link between this psychiatric disorder and substance use by the patients. Another recent line of research is aimed to clarify the causes of anorexia nervosa that result from a complex interaction of genetic and environmental factors." - Anonymous Online Contributor

Unverified Answer

Is estradiol hemihydrate transdermal system typically used in combination with any other treatments?

"The most frequent side effects were pain and irritation. The safety of EHDS appeared to be acceptable with regard to overall tolerability and tolerability to the treatment. When EHDS was used in combination with most or all other treatments, no serious or irreversible side effects occurred." - Anonymous Online Contributor

Unverified Answer

How serious can anorexia nervosa be?

"The mortality rate among patients admitted to the NIMH for treatment is 0.5%; 1% die from the disease during the year before discharge. This is less than one-fourth the mortality rate reported in anorexia nervosa. Thus, we conclude that morbidity and mortality are not the inevitable consequence of malnutrition in these disease states, and we challenge that view. Anorexia nervosa is a disease with a high potential for spontaneous remission; we would advocate clinical trials of any promising therapeutic interventions, considering the significant morbidity and mortality that would likely result from their failure to initiate treatment. This emphasizes the critical necessity in the disease's management: A.N. is a disease that is both chronic and severe requiring lifelong care." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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