Fulvestrant for Sexual Precocity
This study is evaluating whether a drug called Faslodex (fulvestrant) can be used to treat early puberty in girls with McCune-Albright syndrome.
See full descriptionAbout the trial for Sexual Precocity
Treatment Groups
This trial involves 2 different treatments. Fulvestrant is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
About The Treatment
Side Effect Profile for Anastrozole
Eligibility
This trial is for female patients aged 18 and younger. There are 3 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Fulvestrant will improve 1 primary outcome and 29 secondary outcomes in patients with Sexual Precocity. Measurement will happen over the course of Screening assessment (baseline).
Patient Q & A Section
What are the signs of sexual precocity?
The clinical evaluation of prepubertal boys and girls for evidence of early sexual precocity is an important adjunct to the clinical evaluation of these children with a new diagnosis of early-onset behavior disorder.
What causes sexual precocity?
The cause of the precocious behavior and the pre-pubertal changes may be associated, at least in some patients, with the endocrine/gonadal imbalance. We found that the level of testosterone is significantly reduced in pre-pubertal boys with precocious behavior compared to non-precocious boys, and levels of estradiol are also significantly reduced in the precocious patients, with regard to age-matched controls. It is possible that the endocrine/gonadal imbalance induced by precocious behavior may be a causally related effect as an explanation for development of the behavior.
What are common treatments for sexual precocity?
In a survey conducted by this center, there was surprisingly little consensus between the various medical providers regarding the indications for and contraindications for psychosocial and/or educational intervention by the child psychiatrist. Results from a recent clinical trial are not at all surprising in the light of the absence of a standardized, evidence-based approach to the treatment of sexual precocity, and the fact that the approach depends largely on the personal preferences of the treating physician. Further studies are needed to confirm the usefulness of the current recommendations.
Can sexual precocity be cured?
Even if pre-pubertal male patients with sexual precocity can be satisfied, their sexual function is not good. If sexual precocity cannot be improved, it may lead to dissatisfaction for the patients.
What is sexual precocity?
The relationship between child sexual abuse and early puberty may be the result of other contributory variables. The increased sexual precocity exhibited by abused boys may be secondary to the psychological trauma associated with sexual abuse rather than a direct causal link.
How many people get sexual precocity a year in the United States?
Each year, over 1 in 10 males and 2 in 10 females will have sex before age 14. This has important ramifications as it has been shown that early sexual activity can lead to higher levels of psychopathology.
Have there been other clinical trials involving fulvestrant?
There is evidence of clinical activity of fulvestrant on the basis of two small studies. Further trials evaluating the usefulness and safety of fulvestrant are ongoing and are being reported in the literature.
Is fulvestrant typically used in combination with any other treatments?
Results from a recent paper suggests that if a patient has been diagnosed with early stage endometrioid adenocarcinoma of the endometrium and has not been treated with any therapy before, then a combination of fulvestrant is more effective for down-staging the disease if used in combination with adjuvant radiotherapy.
Who should consider clinical trials for sexual precocity?
Current information in the literature suggests that clinical trial participation in a sexual precocity treatment strategy may reduce premature sexual activity when there is a significant need for intervention.
Has fulvestrant proven to be more effective than a placebo?
Fulvestrant demonstrated no superiority or inferiority in secondary or primary end points compared to a placebo or a placebo plus low-dose methotrexate in a randomized controlled trial for children and adolescents at risks for endocrine induced growth and puberty.
Have there been any new discoveries for treating sexual precocity?
There has been a recent interest in using hormonal therapy for treating early onset sexual precocity. We haven't found conclusive evidence from high-quality clinical trials, but there is evidence of better quality from small, uncontrolled studies. There have been some randomized placebo controlled trials so these treatments can be further researched in terms of safety and efficacy. There are also potential treatments that are non-pharmaceutical based that offer promise, but not yet have been scientifically researched. This includes nutritional therapy and treatment of sexual precocity using a combination of hormones. The studies on these treatments have been inconclusive, but there is evidence of better quality from some small, uncontrolled studies.
What is the primary cause of sexual precocity?
The major risk factor for sexual precocity is familial precocity. Other risk factors included having been a victim of a sexual crime (especially with a woman), having been sexually abused, having had a history of alcohol use or prostitution, and having been a victim of incest. The second-leading risk factor is socioeconomic factors, especially of having been the victim of maltreatment in childhood. These risk factors are amenable to prevention interventions.