Role of Estrogen Formulation and Route of Delivery on Skeletal Outcomes in Functional Hypothalmic Amenorrhea
University of Virginia
Summary
The purpose of this study is to assess whether the natural form of estrogen (17-beta estradiol) given as a patch so that it is absorbed through your skin, is better at improving bone strength over 1 year than natural estrogen (17-beta estradiol) taken by mouth, or a synthetic form oestrogen (ethinyl estradiol) given as a patch that also provides birth control. Participants will: 1. Take estrogen for 1 year either (i) in its natural form as a patch twice a week (and progesterone by mouth for 12 days of each month), or (ii) in its natural form as a pill daily (and progesterone by mouth for 12 days of each month), or (iii) in a synthetic form as a birth control patch weekly for 3 weeks with 1 week off the patch. You will not be able to choose which form of estrogen you will receive as this will be assigned to you based on a pre-existing randomization sequence (like the flip of a coin) 2. Take provided calcium and vitamin D supplements 3. Attend 4 study visits over 12 months with two at the beginning and then every 6 months that include: * History and Physical Exams * Lab Work * Imaging studies * Questionnaires * Dietary recalls
Description
Low bone mass is a major co-morbid complication of functional hypothalamic amenorrhea (FHA) in adolescents and young adult women, including those with anorexia nervosa (AN) and exercise-induced amenorrhea (EIA), and the prevalence of fractures is markedly higher than in normal-weight controls (43% in EIA, 38% in AN vs. 22% in controls).1 Adolescence and young adulthood are a critical time for bone accrual. Peak bone mass, a major determinant of bone mineral density (BMD) and fracture risk in adult life, is established between 20-25 years of age in women. Insults to bone accrual during the adol…
Eligibility
- Age range
- 14–30 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Females, age 14-30 years, skeletally mature with bone age ≥ 14 years (only 2% of growth left) * Women of reproductive age: use of an effective non-hormonal contraceptive method or a progestin releasing intrauterine device (no systemic skeletal effects) for study duration if sexually active. Note: Women who receive a progestin implant for contraception after study enrollment will be allowed to continue and will not be excluded from study. * Biochemical criteria: negative βHCG (pregnancy test), TSH within 2x the upper limit of normal, prolactin \<10 ng/mL above upper limit…
Interventions
- Drugtransdermal 17β-E2 with cyclic progestin
100-mcg transdermal 17β-E2 patch (to be applied twice weekly) (continuous use), with 200 mg micronized progesterone given for 12 days of every month
- Drugoral 17β-E2 with cyclic progestin
2 mg of oral 17β-E2 pills daily, with 200 mg micronized progesterone given for 12 days of every month
- Drugtransdermal EE+LNG
transdermal EE (30 mcg) + LNG (120 mcg) contraceptive patch (TWIRLA). Patch will be applied once a week for 3 consecutive weeks, with the 4th week off the patch (to be repeated after 4 weeks).
Locations (2)
- University of Virginia Medical CenterCharlottesville, Virginia
- University of VirginiaCharlottesville, Virginia