#1 Clinical Trials Search in Europe

Leuprorelin Acetate

Leuprorelin acetate, also known as leuprolide acetate, is a hormone therapy drug being studied in clinical trials for various types of cancer, including prostate cancer, breast cancer, and spinal and bulbar muscular atrophy. This article examines how leuprorelin acetate is being used in clinical trials and its potential benefits for patients.

Table of Contents

What is Leuprorelin Acetate?

Leuprorelin Acetate is a medication used in the treatment of various hormone-dependent conditions. It belongs to a class of drugs called gonadotropin-releasing hormone (GnRH) agonists. This medication is also known by several brand names, including Eligard®, Leuplin, and Leuplin SR[1][2].

Conditions Treated with Leuprorelin Acetate

Leuprorelin Acetate is used to treat several conditions, including:

  • Prostate Cancer: It is commonly used in the treatment of prostate cancer, particularly in cases where the cancer is hormone-sensitive[3].
  • Breast Cancer: Leuprorelin Acetate is used in the treatment of premenopausal breast cancer[4].
  • Uterine Fibroids: It can be used to reduce the size of uterine fibroids before surgery[5].
  • Spinal and Bulbar Muscular Atrophy (SBMA): This is a rare genetic disorder that Leuprorelin Acetate has been used to treat[6].
  • Precocious Puberty: In some cases, it’s used to treat children who start puberty too early[5].

How Leuprorelin Acetate Works

Leuprorelin Acetate works by reducing the production of certain hormones in the body. In the case of prostate and breast cancer, it lowers the levels of testosterone and estrogen respectively. These hormones can stimulate the growth of certain types of cancer cells. By reducing hormone levels, Leuprorelin Acetate can slow down or stop the growth of these cancer cells[7].

Administration and Dosage

Leuprorelin Acetate is typically administered as a subcutaneous injection (an injection under the skin). The dosage and frequency of administration can vary depending on the condition being treated and the specific formulation used. Some common dosages include:

  • 11.25 mg injected once every 12 weeks[8]
  • 22.5 mg injected once every 24 weeks[3]
  • 45 mg injected once every 6 months[1]

It’s important to note that the dosage and administration schedule should always be determined by your healthcare provider based on your specific condition and needs.

Effectiveness of Leuprorelin Acetate

The effectiveness of Leuprorelin Acetate has been studied in various clinical trials. For prostate cancer, it has been shown to effectively lower testosterone levels to what’s known as “castration levels” (below 50 ng/dL), which can help slow the progression of the disease[1].

In breast cancer treatment, Leuprorelin Acetate has been used as part of adjuvant therapy (additional treatment given after the primary treatment) to improve outcomes in premenopausal women[9].

For conditions like uterine fibroids, Leuprorelin Acetate has been shown to reduce the size of fibroids and decrease blood loss during surgery[5].

Potential Side Effects and Safety

Like all medications, Leuprorelin Acetate can cause side effects. Some of the potential side effects include:

  • Hot flashes
  • Changes in mood
  • Decreased libido
  • Injection site reactions
  • Changes in bone density with long-term use

It’s important to discuss potential side effects with your healthcare provider. They will monitor you for any adverse reactions during treatment[4][3].

Impact on Quality of Life

While Leuprorelin Acetate can be effective in treating various conditions, it’s also important to consider its impact on quality of life. Some studies have looked at how this medication affects patients’ overall well-being and daily activities. Tools like the Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) have been used to assess this[9].

Factors considered in these assessments include physical condition, daily activities, social activities, and psychological status. Your healthcare provider can discuss with you how Leuprorelin Acetate might affect your quality of life and help you weigh the potential benefits against any impacts on your daily living[1].

Aspect Details
Main uses in trials Prostate cancer, premenopausal breast cancer, spinal and bulbar muscular atrophy (SBMA)
Administration methods Subcutaneous injections (11.25 mg, 22.5 mg, or 45 mg)
Dosing frequency Every 12 weeks, 24 weeks, or 6 months (depending on formulation)
Treatment duration Varies from 48 weeks up to 8 years
Primary outcomes studied Safety, efficacy, quality of life, survival rates, hormone suppression
Potential side effects Menopausal-like symptoms, injection site reactions, bone density changes
Key measurements Testosterone levels, PSA levels, adverse events, progression-free survival

FAQ

  • What is leuprorelin acetate used for in clinical trials? Leuprorelin acetate is being studied in clinical trials for treating prostate cancer, breast cancer in premenopausal women, and spinal and bulbar muscular atrophy (SBMA). It works by reducing hormone levels that can fuel certain types of cancer growth.
  • How is leuprorelin acetate administered? Leuprorelin acetate is typically administered as a subcutaneous injection. Different formulations are being studied, including 11.25 mg injections given every 12 weeks, 22.5 mg injections given every 24 weeks, and 45 mg injections given every 6 months.
  • What are the main outcomes being studied in leuprorelin acetate trials? The main outcomes being studied include safety (adverse events), efficacy in controlling cancer progression, quality of life impacts, survival rates, and maintenance of hormone suppression (e.g. testosterone levels).
  • How long do patients typically receive leuprorelin acetate in clinical trials? The duration of treatment varies between trials, ranging from 48 weeks up to 8 years in some long-term studies. Many trials examine treatment periods of 96 weeks (about 2 years).
  • What are some potential side effects of leuprorelin acetate? Potential side effects may include menopausal-like symptoms such as hot flashes, injection site reactions, changes in bone density, and impacts on sexual function. The trials closely monitor for any adverse events to assess the drug's safety profile.

Ongoing Clinical Trials on Leuprorelin Acetate

  • A Phase I/II Study of GVV858 Alone or in Drug Combination for Patients with Advanced Hormone Receptor‑Positive, HER2‑Negative Breast Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark France Germany Italy Spain

  • Study of ECI830, ribociclib, and fulvestrant in patients with advanced hormone receptor positive, HER2-negative breast cancer and advanced solid tumors

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark France Germany Italy Spain

  • A Study of Camizestrant Compared to Standard Hormone Therapy for Patients with ER-Positive HER2-Negative Early Breast Cancer After Initial Treatment

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Estonia +10

  • Evaluating Elacestrant alone or with leuprorelin in premenopausal women with early-stage hormone receptor positive breast cancer before surgery

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effects of Ribociclib and Endocrine Therapy for Patients with HR-Positive, HER2-Negative Early Breast Cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Portugal

  • Study on the Safety and Effectiveness of Trastuzumab Deruxtecan vs. Palbociclib-Based Drug Combination for Advanced HR-Positive, HER2-Low Breast Cancer Patients

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Germany Italy The Netherlands +3

  • Study on the Effects of Darolutamide and Drug Combination for Patients with Metastatic Hormone-Naïve Prostate Cancer

    Recruiting

    3 1 1 1
    Investigated drugs:
    Belgium Croatia Czechia Denmark France Ireland +4

  • Study on Elacestrant and Everolimus for Patients with Advanced ER+/HER2- Breast Cancer Resistant to Endocrine Therapy and CDK4/6 Inhibitors

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia France Germany Greece Italy +1

  • Study of leuprorelin and progestogen treatment in women with adenomyosis undergoing assisted reproductive technology to improve pregnancy outcomes

    Recruiting

    3 1 1 1
    Investigated drugs:
    Italy

  • Comparison of Short vs Long-term Hormone Therapy with Goserelin, Leuprorelin, or Triptorelin Combined with Radiation for Prostate Cancer Patients After Surgery

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Leuprorelin acetate: A hormone therapy drug that reduces levels of certain hormones in the body. It is used to treat hormone-sensitive cancers and other conditions.
  • Subcutaneous injection: An injection given into the fatty tissue just beneath the skin.
  • Prostate cancer: A type of cancer that occurs in the prostate, a small walnut-shaped gland in males that produces seminal fluid.
  • Premenopausal breast cancer: Breast cancer that occurs in women who have not yet gone through menopause and are still having menstrual periods.
  • Spinal and bulbar muscular atrophy (SBMA): A genetic disorder that primarily affects males, causing muscle weakness and wasting in the arms and legs and bulbar muscles.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment.
  • Efficacy: The ability of a treatment to produce the desired result.
  • Progression-free survival: The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • Quality of life: The standard of health, comfort, and happiness experienced by an individual.
  • Testosterone: A hormone that plays a key role in male traits and reproductive activity.
  • Metastases: The spread of cancer cells from the place where they first formed to another part of the body.
  • PSA (Prostate-Specific Antigen): A protein produced by the prostate gland. Elevated levels may indicate prostate cancer or other prostate conditions.

References

  1. https://clinicaltrials.gov/study/NCT05304169
  2. https://clinicaltrials.eu/trial/study-on-hormonal-treatment-with-leuprorelin-acetate-for-prostate-cancer-patients-at-high-risk-of-recurrence-after-surgery/
  3. https://clinicaltrials.gov/study/NCT03209492
  4. https://clinicaltrials.gov/study/NCT03209518
  5. https://clinicaltrials.gov/study/NCT04192812
  6. https://clinicaltrials.gov/study/NCT03555578
  7. https://clinicaltrials.gov/study/NCT02154139
  8. https://clinicaltrials.gov/study/NCT02167893
  9. https://clinicaltrials.gov/study/NCT02134977