N/A
N=20
Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure
Ovarian Failure, Premature
Bottom Line
View on ClinicalTrials.gov: NCT01023178 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Estradiol — 53; 14; 12 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 17beta Estradiol (Drug); Conjugated estrogens (Drug); 17Beta Estradiol - transdermal (Drug); Progesterone, micronized (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estradiol |
53; 14; 12 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria: in whom initiation of estrogen therapy has been recommended due to ovarian failure
- Outpatients
- age >=12 years to 17.99 years old
Exclusion Criteria
- spontaneous menses
- significant concurrent medical problem including:
- Liver function tests (LFTs) 3 times normal
- clotting disorder
- ongoing cancer treatment
Data sourced from ClinicalTrials.gov (NCT01023178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.