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Raloxifene

Phase 3

Osteoporosis, Postmenopausal | Small molecule | Endocrine |Eli Lilly and Company|Last Updated: May 1, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment7,705

FDA Designations

No designations recorded

Clinical trial landscape

Raloxifene · 3 trials · 5 indications

Phase 3 2Phase 2 1
NCT00190593Raloxifene Use for The HeartCardiovascular Diseases
COMPLETED10,000 Analytics
NCT00670319Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With OsteoporosisOsteoporosis, Postmenopausal
COMPLETED7,705 Analytics
PHASE3COMPLETED
Raloxifene Use for The Heart
Cardiovascular Diseases
NCT0019059310,000
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PHASE3COMPLETED
Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis
Osteoporosis, Postmenopausal
NCT006703197,705
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Study Endpoints

Primary Endpoints

Time to first occurrence of coronary death, non-fatal myocardial infarction (MI), or hospitalized acute coronary syndrome other than MI combined after an expected 5 to 7.5 years of follow-up.
Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.
To establish the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without prevalent vertebral fractures by spinal x-ray.
Screening, 24, 36, and 72 months
To establish the effect of long-term treatment with raloxifene, compared with placebo, on lumbar spine and femoral neck bone mineral density (BMD) in postmenopausal women with osteoporosis.
Screening, baseline, 12, 24, 36, 48, 60 and 72 months
To establish the safety of chronic administration of raloxifene in postmenopausal women with osteoporosis. Adverse events (AEs), physical exam (PE), EKG, mammograms and laboratory tests will be used to assess safety in the patients.
AEs: throughout the trial. PEs: Randomization, 12, 24, 36, 48, 60, 72 months. ECG: Randomization, 24, 48, 72 months. Mammograms: Randomization, 12, 24, 36, 48, 60, 72 months. Labs: Randomization, baseline, 6, 12, 18, 24, 30, 36, 48, 60, 72 months.
Compare the number of vasomotor symptoms at 12 weeks between those women taking the combination of raloxifene with oral estradiol versus those taking raloxifene alone.

Secondary Endpoints

After an expected 5 to 7.5 years of follow-up:
Cardiovascular death, non-fatal MI, hospitalized acute coronary syndrome other than MI, myocardial revascularization, and stroke (individually and combined)
All-cause hospitalization and mortality
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRaloxifene HCL 60 mg orally once a day
2EXPERIMENTALRaloxifene HCL 120 mg orally once a day
3PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
raloxifeneDRUG -
placeboDRUG -
Raloxifene HCLDRUGRaloxifene HCL 60 mg orally once daily
medroxyprogesterone acetateDRUG -
estrogenDRUG -
17 beta estradiolDRUG -
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Eligibility Criteria

Age Range55 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Postmenopausal women with established coronary heart disease or at risk for a major coronary event. Exclusion Criteria: * Postmenopausal symptoms that required estrogen replacement therapy. * Suspected or known history of breast or endometrial carcinoma. * Known or probable ...

Countries:United StatesArgentinaAustraliaAustriaBelgiumCanadaCzechiaDenmarkFinlandFranceGermanyHungaryIsraelItalyMexicoNetherlandsNew ZealandNorwayPolandSingaporeSlovakiaSloveniaSpainSwedenUnited Kingdom
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Frequently asked questions about Raloxifene

What is Raloxifene used for?

Raloxifene is used for vasomotor symptoms, postmenopausal osteoporosis, and cardiovascular diseases. It is a small molecule being developed by Eli Lilly and Company for these endocrine-related conditions. The drug is currently in Phase 3 clinical development.

What does Raloxifene target?

Raloxifene is a selective estrogen receptor modulator that targets estrogen receptors. It is being studied for its effects on vasomotor symptoms, osteoporosis in postmenopausal women, and cardiovascular diseases.

Who makes Raloxifene?

Raloxifene is developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker LLY. The drug is currently in Phase 3 clinical trials for multiple indications.

What phase is Raloxifene in?

Raloxifene is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy for the intended indications.

What clinical trials is Raloxifene in?

Raloxifene has been studied in clinical trials including NCT00190593, a Phase 3 study in cardiovascular diseases and breast neoplasms with 10,000 participants, and NCT00670319, a Phase 3 study in postmenopausal osteoporosis with 7,705 participants. Both trials are completed.

Is Raloxifene the same as Evista?

Raloxifene is also known by the brand name Evista. It is a medication used for the treatment and prevention of osteoporosis in postmenopausal women and for reducing the risk of invasive breast cancer in certain women.