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To directly compare the safety (by laboratory evaluation) and efficacy (feminization and growth) of three commonly used estrogen preparations in adolescent patients with ovarian failure, either due to congenital causes (Turner syndrome) or medical therapies. We hypothesize that transdermal estrogen will have equivalent efficacy and a more favorable safety profile in comparison with conventional oral estrogen replacement.
Treatment with transdermal 17beta(17β) estradiol resulted in higher estradiol levels and more effective feminization compared to oral conjugated equine estrogen but did not result in an otherwise different biochemical profile in this limited number of heterogeneous patients. OBE (oral beta estradiol) and TBE (transdermal beta estradiol) provide safe and effective alternatives to OCEE (oral conjugated equine estrogen) to induce puberty in girls, but larger prospective randomized trials are required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivelle-Dot | Active Comparator | 17Beta Estradiol - transdermal |
|
| Premarin | Active Comparator | Conjugated estrogens |
|
| Estrace | Active Comparator | 17beta Estradiol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17beta Estradiol | Drug | Oral pill given daily at increasing doses every 6 months for 18 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estradiol | Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy. | end of study (up to 2 years) |
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Inclusion Criteria: in whom initiation of estrogen therapy has been recommended due to ovarian failure
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darrell M Wilson | Stanford University | Principal Investigator |
| E Kirk Neely | Stanford University | Study Director |
| Sejal Shah | Stanford University | Sub-Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24982681 | Derived | Shah S, Forghani N, Durham E, Neely EK. A randomized trial of transdermal and oral estrogen therapy in adolescent girls with hypogonadism. Int J Pediatr Endocrinol. 2014;2014(1):12. doi: 10.1186/1687-9856-2014-12. Epub 2014 Jun 20. |
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from 2007-2011 study participants were recruited from pediatric endocrinology clinics at Lucile Packard Children's Hospital at Stanford.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transdermal 17Beta Estradiol | 17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months Progesterone, micronized: Given starting at 18 months |
| FG001 | Oral Conjugated Equine Estrogen | Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months Progesterone, micronized: Given starting at 18 months |
| FG002 | Oral 17beta Estradiol | 17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months. Progesterone, micronized: Given starting at 18 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transdermal 17Beta Estradiol | 17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months Progesterone, micronized: Given starting at 18 months |
| BG001 | Oral Conjugated Equine Estrogen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Estradiol | Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy. | Posted | Mean | Standard Error | pg/mL | end of study (up to 2 years) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transdermal 17Beta Estradiol | 17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months Progesterone, micronized: Given starting at 18 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sejal Shah MD | Stanford University | 6507235791 | sshah2@stanford.edu |
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004966 | Estrogens, Conjugated (USP) |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Conjugated estrogens | Drug | Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months |
|
|
| 17Beta Estradiol - transdermal | Drug | Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months |
|
|
| Progesterone, micronized | Drug | Given starting at 18 months |
|
|
Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months Progesterone, micronized: Given starting at 18 months |
| BG002 | Oral 17beta Estradiol | 17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months. Progesterone, micronized: Given starting at 18 months |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Follicle Stimulating Hormone (FSH) | Mean | Full Range | mIU/mL |
|
| Luteinizing Hormone (LH) | Mean | Full Range | mIU/mL |
|
| OG002 | Oral 17beta Estradiol | 17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months. Progesterone, micronized: Given starting at 18 months |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Oral Conjugated Equine Estrogen | Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months Progesterone, micronized: Given starting at 18 months | 0 | 8 | 0 | 8 |
| EG002 | Oral 17beta Estradiol | 17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months. Progesterone, micronized: Given starting at 18 months | 0 | 7 | 0 | 7 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D003339 | Corpus Luteum Hormones |
| D045167 | Progesterone Congeners |