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Trial · NCT03568708

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) of the Lumbar SpineChange in bone mineral density and body composition from baseline to 24 months
One POI participant had prior oral contraceptive exposure, no matched control, and did not follow up for subsequent visits. For these reasons it was recommended that her data not be included in the analyses.
Z-scoreLEAST_SQUARES_MEAN
SECONDARYChange in Dual Energy X-ray Absorptiometry (DXA) Measure of Bone Mineral Density (BMD) at the Whole Body Less Head, Total Hip, and Femoral Neckbaseline to 24 months
One POI participant had prior oral contraceptive exposure, no matched control, and did not follow up for subsequent visits. For these reasons it was recommended that her data not be included in the analyses.
Z-scoreLEAST_SQUARES_MEAN
SECONDARYChange in Volumetric Bone Mineral Density (vBMD) at the Distal Radius as Measured by Peripheral Quantitative Computed Tomography (pQCT)Change from baseline to 24 months
One POI participant had prior oral contraceptive exposure, no matched control, and did not follow up for subsequent visits. For these reasons it was recommended that her data not be included in the analyses.
mg/mm^3LEAST_SQUARES_MEAN
SECONDARYAnthropometricsBaseline and 24 monthskg/m^2MEAN
SECONDARYChange in Lean Mass as Measured by DXA Body CompositionChange in lean mass from baseline to 24 months
One POI participant had prior oral contraceptive exposure, no matched control, and did not follow up for subsequent visits. For these reasons it was recommended that her data not be included in the analyses.
kgLEAST_SQUARES_MEAN
SECONDARYChange in Symptoms of Anxiety as Measured by Screen for Child Anxiety Related Disorders (SCARED)Change from SCARED score baseline to 24 months
One POI participant had prior oral contraceptive exposure, no matched control, and did not follow up for subsequent visits. For these reasons it was recommended that her data not be included in the analyses.
score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Symptoms of Depression as Measured by Child Depression Inventory-II (CDI-II)Change from CDI-II score from baseline to 24 months
One POI participant had prior oral contraceptive exposure, no matched control, and did not follow up for subsequent visits. For these reasons it was recommended that her data not be included in the analyses.
T-scoreLEAST_SQUARES_MEAN
SECONDARYChange in Memory as Assessed by the Children and Adolescent Memory Profile (CHAMP) Total Memory Index ScoreChange from score from baseline to 24 monthsscore on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Quality of Life as Assessed by the Child Health Questionnaire-Child Self-Report Form (CHQ-CF87)Change from baseline to 24 months
One POI participant had prior oral contraceptive exposure, no matched control, and did not follow up for subsequent visits. For these reasons it was recommended that her data not be included in the analyses.
score on a scaleLEAST_SQUARES_MEAN
SECONDARYCompliance With Transdermal Estrogen PatchPatch Calendars were collected at 6 months, 12 months, 18 months and 24 months. Data presented is through study completion.As only participants with POI were prescribed TDE2 patches, we only report data on this cohort.percentage of weeks with TDE2 useMEAN
SECONDARYStudy Medications - Serum EstradiolBaseline, 12 months, 24 months
The study was originally designed as a 12 month longitudinal trial. Subjects were given the option to continue for 24 months. One case participant declined the extension. As only participants with POI were prescribed transdermal estradiol patches, we only report data on this cohort.
pg/mLMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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