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NCT00278915 · ClinicalTrials.gov registry record · Phase 2

Faslodex in McCune-Albright Syndrome

A Phase 2 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT00278915: Completed Phase 2 study, sponsored by AstraZeneca.

NCT00278915 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00278915, a Phase 2 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (PPP) (early puberty) in girls with McCune-Albright syndrome (MAS)

Primary Outcome

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 ca

Interventions

  • DRUG Fulvestrant

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2006-01-31
Est. Completion 2023-07-20
Phase Phase 2
AstraZeneca

1,285 total trials

What the finished NCT00278915 record still lists

NCT00278915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which Fulvestrant is the first listed.

NCT00278915 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00278915 about?

NCT00278915 is a clinical study titled "Faslodex in McCune-Albright Syndrome". The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (PPP) (early puberty) in girls with McCune-Albright syndrome (MAS)

What is the current status of trial NCT00278915?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2006-01-31. Estimated completion is 2023-07-20.

What interventions are being tested in trial NCT00278915?

The interventions under investigation include: Fulvestrant (DRUG).

Who is sponsoring clinical trial NCT00278915?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00278915's enrollment target sits among peer trials

30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00278915, the US trial registry maintained by the National Library of Medicine. NCT00278915 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.