Comparison · NCT01301183-sae
Rh IGF-1 + Transdermal Estradiol vs Placebo + Transdermal Estradiol: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Rh IGF-1 + Transdermal Estradiol vs Placebo + Transdermal Estradiol: serious adverse events. Trial comparisons, record NCT01301183-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01301183-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.184 | 0.0922 | 0.334 | wilson | |
| Risk in group 2 | 0.324 | 0.196 | 0.485 | wilson | |
| Risk difference, group 1 minus group 2 | -0.14 | -0.326 | 0.0571 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.568 | 0.251 | 1.28 | log | |
| Odds ratio, group 1 over group 2 | 0.47 | 0.161 | 1.37 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rh IGF-1 + Transdermal Estradiol than on Placebo + Transdermal Estradiol | 7.14 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rh IGF-1 + Transdermal Estradiol | RhIGF-1 with transdermal 17-beta estradiol~RhIGF-1 with transdermal 17-beta estradiol: RhIGF-1 will be started at a dose of 30mcg/k/dose twice daily, and will be titrated up or down in 25% dose increments to maintain IGF-1 levels in the upper half of the normal range.~Estradiol will be delivered transdermally using a 100 mcg patch (Vivelle Dot) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D. | 7 | 38 | EG000 |
| Group 2 | Placebo + Transdermal Estradiol | Placebo and transdermal 17-beta estradiol~Placebo and transdermal 17-beta estradiol: Placebo injections will be administered twice daily.~Estradiol will be delivered transdermally using a patch (100 mcg) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D. | 12 | 37 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 1 years
Source ClinicalTrials.gov
Trial
- Title
- Effects of Anorexia Nervosa on Peak Bone Mass
- NCT number
- NCT01301183
- Phases
- PHASE3
- Conditions
- Anorexia Nervosa
- Interventions
- RhIGF-1 with transdermal 17-beta estradiol, Placebo and transdermal 17-beta estradiol
- Lead sponsor
- Massachusetts General Hospital
- Results first posted
- 2021-07-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01301183?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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