Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2020-01-21
2022-12-13
Brief Summary
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Detailed Description
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While numerous studies have sought to orally replace estrogen in adolescents and women with AN, the replacement therapy suppresses IGF-1, and as a result oral estrogen studies have demonstrated no bone health benefit in AN. However, transdermal physiologic estrogen, due to no first-pass metabolism in the liver, is not IGF-1 suppressive. IGF-1 is known to be hormone that directly affects bone formation and is considered to be osteoanabolic (helps increase bone mass).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
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.
Estradiol Hemihydrate Transdermal System
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. 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 Treatment
The participants in this group will not receive the estrogen patch nor the oral progesterone.
No interventions assigned to this group
Interventions
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Estradiol Hemihydrate Transdermal System
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. 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* Use of supraphysiologic corticosteroids for greater than three months
* Pregnancy or attempting pregnancy
* Cigarette smoker
* Known history of a blood clotting disorder (i.e. Factor V Leiden, Protein C Deficiency, etc.)
* Known predisposition to estrogen-related cancers, such as breast or ovarian cancer (e.g. BRCA1)
* Hypersensitivity to this drug or to any ingredient in the formulation or component of the container
* Liver dysfunction or disease as long as liver function tests have failed to return to normal
* Known or suspected estrogen-dependent malignant neoplasia (e.g. endometrial cancer)
* Endometrial hyperplasia
* Known, suspected, or past history of breast cancer
* Undiagnosed abnormal genital bleeding
* Known or suspected pregnancy or lactation
* Active or past history of arterial thromboembolic disease (e.g. stroke, myocardial infarction, coronary heart disease)
* Active or past history of confirmed venous thromboembolism (such as deep vein thrombosis or pulmonary embolism) or active thrombophlebitis
* A high risk of venous or arterial thrombosis, including known thrombophilic disorders
* Partial or complete loss of vision due to ophthalmic vascular disease
* Presence or history of liver tumours (benign or malignant)
* Ongoing use of estrogen containing contraception (oral birth control pill, vaginal ring, patches, depo injections)
12 Years
19 Years
FEMALE
No
Sponsors
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Jim Pattison Children's Hospital Foundation
UNKNOWN
University of Saskatchewan
OTHER
Responsible Party
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Munier Nour
Principal Investigator
Principal Investigators
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Munier Nour
Role: PRINCIPAL_INVESTIGATOR
Faculty
Locations
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Royal University Hospital
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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PRE-GAiN-01
Identifier Type: -
Identifier Source: org_study_id