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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR LUPRON DEPOT


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505(b)(2) Clinical Trials for Lupron Depot

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00626431 ↗ A Study of Leuprolide to Treat Prostate Cancer Completed Abbott Phase 3 2008-02-01 To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to <= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of the 2-sided 90% confidence interval), a protocol-specified criterion.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Lupron Depot

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001181 ↗ Testolactone for the Treatment of Girls With LHRH Resistant Precocious Puberty Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 1982-10-01 The normal changes of puberty, such as breast enlargement, pubic hair and menstrual periods, usually begin between the ages of 9 and 15 in response to hormones produced in the body. Some children's bodies produce these hormones before the normal age and start puberty too early. This condition is known as precocious puberty. The hormones responsible for the onset of puberty come from the pituitary gland and the ovaries. The hormones from the pituitary gland act on the ovaries to produce different hormones that cause the breasts to grow, pubic hair to develop, and menstruation. Many children with precocious puberty can be treated with a medication known as lutenizing hormone-releasing hormone analog (Lupron, Histerelin, Deslorelin). This drug is made in a laboratory and is designed to act like the natural hormone LHRH, which is made in the pituitary gland. The drug causes the pituitary gland to decrease the amount of hormones it is releasing and thereby decrease the amount of hormones released by the ovaries. However, some girls already have low levels of pituitary hormones and yet their ovaries still produce hormones. Researchers do not believe that LHRH analog therapy will work for these children. Testolactone is a drug that acts directly on the ovary. It works by preventing the last step of estrogen production in the ovary. The goal of this treatment is to stop estrogen production and delay the onset of puberty until the normal age. Researchers will give patients with LHRHa resistant precocious puberty Testolactone for six months. If the initial treatment is successful and patients do not experience very bad side effects, they will continue to receive the medication until puberty is desired. Throughout the therapy patients will receive frequent monitoring of their general state of health, hormone levels, and medication levels.
NCT00001259 ↗ A Treatment Study for Premenstrual Syndrome (PMS) Completed National Institute of Mental Health (NIMH) Phase 1 1992-08-11 This study examines the effects of estrogen and progesterone on mood, the stress response, and brain function and behavior in women with premenstrual syndrome. Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to be an effective treatment for PMS. The current purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in women with PMS. PMS is a condition characterized by changes in mood and behavior that occur during the second phase of the normal menstrual cycle (luteal phase). This study will investigate possible hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. The results of these hormonal studies will be compared between women with PMS and healthy volunteers without PMS (see also protocol 92-M-0174). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.
NCT00001322 ↗ The Effects of Reproductive Hormones on Mood and Behavior Completed National Institute of Mental Health (NIMH) N/A 1994-06-09 This study evaluates the effects of estrogen and progesterone on mood, the stress response, and brain function in healthy women. The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without PMS. This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.) will be performed during the different hormonal conditions (low estrogen and progesterone, progesterone add-back, estrogen add-back). The results of these studies will be compared between women without PMS and women with PMS (see also protocol 90-M-0088). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.
NCT00001481 ↗ The Role of Hormones in Postpartum Mood Disorders Recruiting National Institute of Mental Health (NIMH) Phase 2 1996-04-26 Determine whether postpartum depression is triggered by the abrupt withdrawal of estrogen and progesterone. The appearance of mood and behavioral symptoms during pregnancy and the postpartum period has been extensively reported. While there has been much speculation about possible biologically based etiologies for postpartum disorders (PPD), none has ever been confirmed. Preliminary results from two related studies (protocols 90-M-0088, 92-M-0174) provide evidence that women with menstrual cycle related mood disorder, but not controls, experience mood disturbances during exogenous replacement of physiologic levels of gonadal steroids. The present protocol is designed to create a "scaled-down" hormonal milieu of pregnancy and the puerperium in order to determine whether women who have had a previous episode of postpartum major effective episode will experience differential mood and behavioral effects compared with controls and to determine whether it is the abrupt withdrawal of gonadal steroids or the prolonged exposure to gonadal steroids that is associated with mood symptoms. Supraphysiologic plasma levels of gonadal steroids will be established, maintained, and then rapidly reduced, simulating the hormonal events that occur during pregnancy and parturition. This will be accomplished by administering estradiol and progesterone to women who are pretreated with a gonadotropin releasing hormone (GnRH) agonist (Lupron). After eight weeks, administration of gonadal steroids will be stopped in one group of patients and controls, and a sudden decline in the plasma hormone levels will be precipitated. Another group will be maintained on supraphysiologic levels of estrogen and progesterone for an additional month. Outcome measures will include mood, behavioral and hormonal parameters (a separate protocol done in collaboration with NICHD).
NCT00002597 ↗ Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer Completed National Cancer Institute (NCI) Phase 3 1994-10-01 RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
NCT00002597 ↗ Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer Completed Radiation Therapy Oncology Group Phase 3 1994-10-01 RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lupron Depot

Condition Name

Condition Name for Lupron Depot
Intervention Trials
Prostate Cancer 44
Prostate Adenocarcinoma 11
Infertility 7
Stage IV Prostate Cancer 6
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Condition MeSH

Condition MeSH for Lupron Depot
Intervention Trials
Prostatic Neoplasms 71
Adenocarcinoma 19
Infertility 7
Syndrome 6
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Clinical Trial Locations for Lupron Depot

Trials by Country

Trials by Country for Lupron Depot
Location Trials
United States 631
Canada 39
United Kingdom 14
Germany 9
Brazil 7
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Trials by US State

Trials by US State for Lupron Depot
Location Trials
California 34
Texas 31
Maryland 29
New York 27
Colorado 24
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Clinical Trial Progress for Lupron Depot

Clinical Trial Phase

Clinical Trial Phase for Lupron Depot
Clinical Trial Phase Trials
Phase 4 15
Phase 3 25
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Lupron Depot
Clinical Trial Phase Trials
Completed 62
Recruiting 26
Terminated 15
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Clinical Trial Sponsors for Lupron Depot

Sponsor Name

Sponsor Name for Lupron Depot
Sponsor Trials
National Cancer Institute (NCI) 27
M.D. Anderson Cancer Center 11
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 9
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Sponsor Type

Sponsor Type for Lupron Depot
Sponsor Trials
Other 148
Industry 61
NIH 52
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LUPRON DEPOT: Clinical Trials, Market Analysis, and Projections

Introduction to LUPRON DEPOT

LUPRON DEPOT, a formulation of leuprolide acetate, is a widely used luteinizing hormone-releasing hormone (LHRH) agonist. It is primarily prescribed for the treatment of advanced prostate cancer, uterine fibroids, and central precocious puberty (CPP). Here, we will delve into the clinical trials, market analysis, and future projections for LUPRON DEPOT.

Clinical Trials and Efficacy

Testosterone Suppression in Prostate Cancer

Clinical trials have consistently shown that LUPRON DEPOT is highly effective in suppressing testosterone levels, which is crucial for managing advanced prostate cancer. Studies have demonstrated that:

  • The 4-month formulation of LUPRON DEPOT suppressed testosterone to ≤20 ng/dL in 94% of patients at week 48[1][5].
  • The 6-month formulation achieved testosterone suppression in 93% of patients[5].
  • The 3-month and 1-month formulations also showed significant testosterone suppression, with 95% and 94% of patients achieving the desired levels, respectively[5].

Central Precocious Puberty (CPP)

In the treatment of CPP, LUPRON DEPOT-PED has been shown to effectively suppress clinical sexual characteristics and hormone levels.

  • A prospective, multicenter study from 1991 to 2009 found that LUPRON DEPOT-PED 1-month suppressed breast development in 66.7% to 90.6% of females and genitalia development in 60% to 100% of males during 5 years of treatment[3].
  • The 3-month formulation also demonstrated sustained suppression of peak stimulated LH concentrations to <4.0 mIU/mL from month 1 through month 6[3].

Market Analysis

Market Size and Growth

The leuprolide acetate market, which includes LUPRON DEPOT, is experiencing significant growth driven by increasing cases of cancer and other conditions such as uterine fibroids.

  • The market size was valued at USD 2.3 billion in 2024 and is projected to reach USD 5.41 billion by 2037, with a compound annual growth rate (CAGR) of over 6.8% during the forecast period from 2025 to 2037[2].

Product Formulations and Distribution

LUPRON DEPOT is available in various formulations, including vials, prefilled syringes, and lyophilized powder. The prefilled syringes segment is expected to gain a robust revenue share due to their convenience, accuracy, and safety.

  • Prefilled syringes, such as the dual-chamber syringes used for LUPRON DEPOT, offer benefits like maintaining drug potency and reducing the cost of administration[2].

Regional Market Performance

The market is geographically segmented, with North America expected to hold the largest revenue share by 2037, driven by increased healthcare spending and better medical access.

  • North America is anticipated to account for 40% of the market share, followed by Europe, which is also seeing significant growth due to advancements in medical care[2].

Market Drivers and Challenges

Drivers

  • Increasing Prevalence of Cancer: The growing number of cancer cases globally, particularly prostate cancer, is a major driver for the leuprolide acetate market[2].
  • Uterine Fibroids: The high prevalence of uterine fibroids among women of reproductive age also fuels the demand for leuprolide acetate[2].
  • Advancements in Medical Care: Improvements in healthcare infrastructure and medical treatments in regions like North America and Europe contribute to market growth[2].

Challenges

  • Side Effects and Adverse Reactions: While effective, LUPRON DEPOT can have significant side effects, including hot flashes, bone density loss, and potential cardiovascular risks, which can impact patient compliance and market growth[1][3].
  • Competition: The market faces competition from other LHRH agonists and emerging treatments, which can affect market share[4].

Future Projections

Market Growth and Trends

The leuprolide acetate market is expected to continue its upward trend, driven by the increasing incidence of cancer and other conditions.

  • By 2037, the market is projected to more than double its current size, reflecting a strong demand for effective treatments like LUPRON DEPOT[2].

Technological and Formulation Advancements

Future advancements in formulation and delivery systems, such as more convenient and accurate prefilled syringes, are likely to enhance patient compliance and market growth.

  • Innovations in drug delivery could further improve the efficacy and safety profile of LUPRON DEPOT, making it a preferred choice for clinicians and patients[2].

Regional Expansion

The market is expected to expand in various regions, with North America and Europe leading the way due to their advanced healthcare systems and high spending on medical treatments.

  • Emerging markets in Asia Pacific and Latin America are also anticipated to contribute significantly to the growth of the leuprolide acetate market[2][4].

Key Takeaways

  • Clinical Efficacy: LUPRON DEPOT has been proven to be highly effective in suppressing testosterone levels in prostate cancer patients and in managing CPP.
  • Market Growth: The leuprolide acetate market is projected to grow significantly, driven by increasing cancer cases and advancements in medical care.
  • Product Formulations: Prefilled syringes are expected to dominate the market due to their convenience and accuracy.
  • Regional Performance: North America and Europe will continue to be the leading regions in the market.

FAQs

Q: What is LUPRON DEPOT used for?

LUPRON DEPOT is primarily used for the treatment of advanced prostate cancer, uterine fibroids, and central precocious puberty (CPP).

Q: How effective is LUPRON DEPOT in suppressing testosterone?

Clinical trials have shown that LUPRON DEPOT suppresses testosterone to ≤20 ng/dL in 93% to 95% of prostate cancer patients, depending on the formulation[1][5].

Q: What are the common side effects of LUPRON DEPOT?

Common side effects include hot flashes, bone density loss, and potential cardiovascular risks.

Q: Which regions are expected to lead the market growth for LUPRON DEPOT?

North America and Europe are anticipated to hold the largest revenue shares due to their advanced healthcare systems and high spending on medical treatments[2].

Q: What is the projected market size for leuprolide acetate by 2037?

The market is expected to reach USD 5.41 billion by 2037, with a CAGR of over 6.8% from 2025 to 2037[2].

Sources

  1. LupronProstateCancer.com: Effective Testosterone Suppression.
  2. ResearchNester.com: Leuprolide Acetate Market Size & Share | Forecast Report 2037.
  3. LupronPedPro.com: Clinical Studies | LUPRON DEPOT-PED® (leuprolide acetate for pediatric use).
  4. CognitiveMarketResearch.com: Lupron Market Report 2024 (Global Edition).
  5. LupronProstateCancer.com: Study Results With LUPRON DEPOT.

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