Trial · NCT00278915
Faslodex in McCune-Albright Syndrome
NCT00278915, Phase 2, Completed, AstraZeneca; results first posted 2011-07-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Faslodex in McCune-Albright Syndrome. Trials, record NCT00278915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00278915
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Faslodex in McCune-Albright Syndrome
- NCT number
- NCT00278915
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Puberty, Precocious, McCune-Albright Syndrome
- Interventions
- Fulvestrant
- First posted
- 2006-01-19
- Last updated
- 2024-03-05
- Other registries' IDs
- eudract:2005-004893-26
- Results first posted
- 2011-07-19
- Limitations and caveats
Data for exploration on body weight and race effect on fulvestrant PK is not available due to small sample size. Data for number and size of ovarian cysts at different time-point were too sparse to produce a meaningful summary, hence not reported.
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Frequency of Annualized Days of Vaginal Bleeding on Treatment Compared to Baseline | Baseline (6 month pre-treatment observation period) through Month 12 treatment period | Vaginal bleeding days are defined as the number of days in which vaginal bleeding, (including spotting) occurred. In order to annualize, a 12-month period is defined as 360 days and a 6-month period is defined as 180 days. Frequency of annualized vaginal bleeding days = \[(number of vaginal bleeding days)/(total number of days of the time interval under consideration)\] multiplied by 360. Change in frequency is equal to the on-treatment frequency minus the baseline frequency. Diary cards will capture days of vaginal bleeding during the 12-month treatment period. Change in the frequency of annualized days of vaginal bleeding during the 12-month treatment period compared to the 6-month baseline period, based on a worst-case scenario calculation (ie, missing diary card days counted as bleeding days) are reported. |
| Primary | Percentage of Participants With Baseline Vaginal Bleeding Who Experienced ≥ 50% Reduction in the Number of Vaginal Bleeding Days on Treatment Compared to Baseline | Baseline (6 month pre-treatment observation period) through Month 12 treatment period | The percentage change in frequency is defined as 100% times the difference (the on-treatment period frequency minus the baseline period frequency), divided by the baseline period frequency. The percentage of participants with baseline vaginal bleeding days who experienced ≥ 50% reduction in the number of vaginal bleeding days during the 12 month treatment period compared to the 6 month baseline period based on a worst-case approach (ie, missing diary card days counted as bleeding days) are reported. |
| Primary | Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over a 6-month Treatment Period | Baseline (6-month pre-treatment observation period) through Month 12 treatment period | Percentage of participants with baseline vaginal bleeding who experienced cessation of vaginal bleeding days over a 6-month treatment period based on a worst-case approach (ie, missing diary card days counted as bleeding days) are reported. |
| Primary | Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over the Whole 12-month Treatment Period | Baseline (6 month pre-treatment observation period) through Month 12 treatment period | Percentage of participants with baseline vaginal bleeding who experienced cessation of vaginal bleeding days over a 12-month treatment period based on a worst-case approach (ie, missing diary card days counted as bleeding days) are reported. |
| Primary | Change in Rate of Bone Age (BA) Advancement Over First 6-month Treatment Period Compared to Baseline | Baseline (6-month pre-treatment observation period) through Month 6 of treatment period | Change in rate of BA advancement over first 6-month treatment period compared to baseline (6-month pre-treatment observation period) is reported. Increase in BA is defined as BA (expressed as fractional years) at end of time period minus BA at beginning of time period (unit: years). Rate of increase in BA for a particular time interval is increase in BA during this time interval adjusted (ie, normalized) for the length of this time interval. Rate of BA advancement is change in BA (years) divided by change in chronological age (CA) (years). Change in rate of increase in BA from baseline period to on-treatment period is defined as increase in BA divided by change in CA (in fractional years) between BA radiograph dates. It is calculated as \[(BA6 - BA0)/(CA6 - CA0)\] - \[(BA0 - BA\*)/(CA0 - CA\*)\], where 6, 0, \* stand for first Month 6 Visit, Month 0 Visit, and the 6-month retrospective visit, respectively. |
| Primary | Change in Rate of BA Advancement Over Second 6-month Treatment Period Compared to Baseline | Baseline (6-month pre-treatment observation period) through second Month 6 of treatment period | Change in rate of BA advancement over second 6-month treatment period compared to baseline (6-month pre-treatment observation period) is reported. Increase in BA is defined as BA (expressed as fractional years) at end of time period minus BA at beginning of time period (unit: years). Rate of increase in BA for a particular time interval is increase in BA during this time interval adjusted (ie, normalized) for the length of this time interval. Rate of BA advancement is change in BA (years) divided by change in CA (years). Change in rate of increase in BA from baseline period to on-treatment period is defined as increase in BA divided by change in CA (in fractional years) between the BA radiograph dates. It is calculated as \[(BA6 - BA0)/(CA6 - CA0)\] - \[(BA0 - BA\*)/(CA0 - CA\*)\], where 6, 0, \* stand for second Month 6 Visit, Month 0 Visit, and the 6-month retrospective visit, respectively. |
| Primary | Change in Rate of BA Advancement Over the Whole 12-month Treatment Period Compared to Baseline | Baseline (6-month pre-treatment observation period) through Month 12 of treatment period | Change in rate of BA advancement over whole 12-month treatment period compared to baseline (6-month pre-treatment observation period) is reported. Increase in BA is defined as BA (expressed as fractional years) at end of time period minus BA at beginning of time period (unit: years). Rate of increase in BA for a particular time interval is increase in BA during this time interval adjusted (ie, normalized) for the length of this time interval. Rate of BA advancement is change in BA (years) divided by change in CA (years). Change in rate of increase in BA from baseline period to on-treatment period is defined as increase in BA divided by change in CA (in fractional years) between the BA radiograph dates. It is calculated as \[(BA12 - BA0) / (CA12 - CA0)\] - \[(BA0 - BA\*) / (CA0 - CA\*)\], where 12, 0, \* stand for Month 12 Visit, Month 0 Visit, and the 6-month retrospective visit, respectively. |
| Primary | Change in Growth Velocity (Annualized Growth Velocity in cm/Year) Over First 6-month Treatment Period Compared to Baseline | Baseline (6 month pre-treatment observation period) through first 6-month of treatment period | Change in growth velocity (annualized growth velocity in cm/year) from the baseline (pre-treatment period) to first 6-month treatment period is reported. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year). Baseline growth velocity was calculated from 6-month observational/retrospective period of the study. Change in growth velocity was calculated as growth velocity on treatment minus change in growth velocity during baseline. |
| Primary | Change in Growth Velocity (Annualized Growth Velocity in cm/Year) Over Second 6-month Treatment Period Compared to Baseline | Baseline (6 month pre-treatment observation period) through second 6-month treatment period (ie, through 12-month treatment period) | Change in growth velocity (annualized growth velocity in cm/year) from the baseline (pre-treatment period) to second 6-month treatment period is reported. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year). Baseline growth velocity was calculated from 6-month observational/retrospective period of the study. Change in growth velocity was calculated as growth velocity on treatment minus change in growth velocity during baseline. |
| Primary | Change in Growth Velocity (Annualized Growth Velocity in cm/Year) Over Whole 12-month Treatment Period Compared to Baseline | Baseline (6 month pre-treatment observation period) through Month 12 of treatment period | Change in growth velocity (annualized growth velocity in cm/year) from the baseline (pre-treatment period) to the 12-month treatment period is reported. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year). Baseline growth velocity was calculated from 6-month observational/retrospective period of the study. Change in growth velocity was calculated as growth velocity on treatment minus change in growth velocity during baseline. |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Frequency of Annualized Days of Vaginal Bleeding on Treatment Compared to Baseline | Baseline (6 month pre-treatment observation period) through Month 12 treatment period | The full-analysis set (FAS) population included participants who received at least 1 dose of study drug. | Days per year | MEDIAN |
| PRIMARY | Percentage of Participants With Baseline Vaginal Bleeding Who Experienced ≥ 50% Reduction in the Number of Vaginal Bleeding Days on Treatment Compared to Baseline | Baseline (6 month pre-treatment observation period) through Month 12 treatment period | The FAS population included participants who received at least 1 dose of study drug. Here, number of participants analyzed denotes those participants who had bleeding during the 6 month baseline period. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over a 6-month Treatment Period | Baseline (6-month pre-treatment observation period) through Month 12 treatment period | The FAS population included participants who received at least 1 dose of study drug. Here, number of participants analyzed denotes those participants who had bleeding during the 6-month baseline period. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over the Whole 12-month Treatment Period | Baseline (6 month pre-treatment observation period) through Month 12 treatment period | The FAS population included participants who received at least 1 dose of study drug. Here, number of participants analyzed denotes those participants who had bleeding during the 6 month baseline period. | Percentage of Participants | NUMBER |
| PRIMARY | Change in Rate of Bone Age (BA) Advancement Over First 6-month Treatment Period Compared to Baseline | Baseline (6-month pre-treatment observation period) through Month 6 of treatment period | The FAS population included participants who received at least 1 dose of study drug. | Ratio | MEAN |
| PRIMARY | Change in Rate of BA Advancement Over Second 6-month Treatment Period Compared to Baseline | Baseline (6-month pre-treatment observation period) through second Month 6 of treatment period | The FAS population included participants who received at least 1 dose of study drug. Here, number of participants analyzed denotes those participants who were evaluable at the specified time point. | Ratio | MEAN |
| PRIMARY | Change in Rate of BA Advancement Over the Whole 12-month Treatment Period Compared to Baseline | Baseline (6-month pre-treatment observation period) through Month 12 of treatment period | The FAS population included participants who received at least 1 dose of study drug. | Ratio | MEAN |
| PRIMARY | Change in Growth Velocity (Annualized Growth Velocity in cm/Year) Over First 6-month Treatment Period Compared to Baseline | Baseline (6 month pre-treatment observation period) through first 6-month of treatment period | The FAS population included participants who received at least 1 dose of study drug. | cm/year | MEAN |
| PRIMARY | Change in Growth Velocity (Annualized Growth Velocity in cm/Year) Over Second 6-month Treatment Period Compared to Baseline | Baseline (6 month pre-treatment observation period) through second 6-month treatment period (ie, through 12-month treatment period) | The FAS population included participants who received at least 1 dose of study drug. | cm/year | MEAN |
| PRIMARY | Change in Growth Velocity (Annualized Growth Velocity in cm/Year) Over Whole 12-month Treatment Period Compared to Baseline | Baseline (6 month pre-treatment observation period) through Month 12 of treatment period | The FAS population included participants who received at least 1 dose of study drug. | cm/year | MEAN |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Frequency of Annualized Days of Vaginal Bleeding on Treatment Compared to Baseline | Fulvestrant | -3.6 | Full Range -42 to 185 | Days per year | |
| Percentage of Participants With Baseline Vaginal Bleeding Who Experienced ≥ 50% Reduction in the Number of Vaginal Bleeding Days on Treatment Compared to Baseline | Fulvestrant | 73.9 | 95% Confidence Interval 51.6 to 89.8 | Percentage of Participants | |
| Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over a 6-month Treatment Period | Fulvestrant | 78.3 | 95% Confidence Interval 56.3 to 92.5 | Percentage of Participants | |
| Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over the Whole 12-month Treatment Period | Fulvestrant | 34.8 | 95% Confidence Interval 16.4 to 57.3 | Percentage of Participants | |
| Change in Rate of Bone Age (BA) Advancement Over First 6-month Treatment Period Compared to Baseline | Fulvestrant | -0.83 | Standard Deviation 1.507 | Ratio | |
| Change in Rate of BA Advancement Over Second 6-month Treatment Period Compared to Baseline | Fulvestrant | -1.10 | Standard Deviation 1.383 | Ratio | |
| Change in Rate of BA Advancement Over the Whole 12-month Treatment Period Compared to Baseline | Fulvestrant | -0.93 | Standard Deviation 1.343 | Ratio | |
| Change in Growth Velocity (Annualized Growth Velocity in cm/Year) Over First 6-month Treatment Period Compared to Baseline | Fulvestrant | -1.7 | Standard Deviation 4.35 | cm/year | |
| Change in Growth Velocity (Annualized Growth Velocity in cm/Year) Over Second 6-month Treatment Period Compared to Baseline | Fulvestrant | -0.8 | Standard Deviation 4.49 | cm/year | |
| Change in Growth Velocity (Annualized Growth Velocity in cm/Year) Over Whole 12-month Treatment Period Compared to Baseline | Fulvestrant | -1.4 | Standard Deviation 3.69 | cm/year |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fulvestrant | 30 | |
| Overall Study | COMPLETED | Fulvestrant | 29 | |
| Overall Study | NOT COMPLETED | Fulvestrant | 1 |
Source ClinicalTrials.gov
Adverse events53
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pyrexia | General disorders | Fulvestrant | 14 | 30 | 32 |
| other | Injection Site Inflammation | General disorders | Fulvestrant | 4 | 30 | 4 |
| other | Fatigue | General disorders | Fulvestrant | 2 | 30 | 2 |
| other | Injection Site Pain | General disorders | Fulvestrant | 2 | 30 | 6 |
| other | Abdominal Pain | Gastrointestinal disorders | Fulvestrant | 8 | 30 | 21 |
| other | Vomiting | Gastrointestinal disorders | Fulvestrant | 8 | 30 | 12 |
| other | Diarrhoea | Gastrointestinal disorders | Fulvestrant | 5 | 30 | 7 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Fulvestrant | 4 | 30 | 7 |
| other | Toothache | Gastrointestinal disorders | Fulvestrant | 3 | 30 | 6 |
| other | Nausea | Gastrointestinal disorders | Fulvestrant | 2 | 30 | 6 |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fulvestrant | 0 | 30 |
| Total, other adverse events | Fulvestrant | 25 | 30 |
| Total, serious adverse events | Fulvestrant | 9 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22999294 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00278915
GET https://conductscience.org/api/trials/v1/NCT00278915/registered?page=2