PRE-GAiN Bone Health Pilot Study

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This study will assess the affects of an estradiol hemihydrate transdermal system on bone health in 24 adolescent females aged 12-19 years old with anorexia nervosa. Participants in this study will be randomized 1:1 into 2 groups. One group will receive treatment with a transdermal estrogen patch and the other group will not.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Saskatchewan
• Collaborator: Jim Pattison Children's Hospital Foundation
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estrogens; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Uncontrolled or chronic medical conditions that may influence bone health (i.e. hyperthyroidism, diabetes mellitus, or celiac disease)

• 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)