CLINICAL TRIALS PROFILE FOR TRIPTORELIN PAMOATE

All Clinical Trials for Triptorelin Pamoate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00124514 ↗	Triptorelin for Ovary Protection in Childhood Onset Lupus	Completed	Watson Pharmaceuticals	Phase 2	2003-06-01	The purpose of this study is to test the safety of triptorelin when used for the protection of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for systemic lupus erythematosus (SLE; lupus) and to see what effects (good or bad) it has on patients. The study will be done with female patients who have been diagnosed with systemic lupus erythematosus, are younger than 21 years of age, and require intravenous cyclophosphamide to control the disease. Each patient will be in the study for approximately 23 months, until 4 months after the intravenous cyclophosphamide treatment has been completed. This study is currently being conducted at 3 sites across the United States and Brazil (Los Angeles, Cincinnati and San Paulo Brazil). A total of 50 patients will participate in this study. Each patient will be randomized (assigned) to one of 5 groups. Randomization means that patients are put into a group completely by chance. It is like flipping a coin. Neither the patient nor the study staff knows what group the patient is in. The patient has a 20% chance of being placed in any group. This is a dose escalation study, each patient will receive the first dose of the study drug (T1 - T4, placebo). If a patient has complete ovarian suppression on day 27 after the initial injection of study drug, then she will remain on this weight-adjusted dose of study drug throughout the study. The dose will be increased up for a weight gain of 5kg or greater. The dose will not be adjusted downward for a weight loss. If COS was not maintained with the 1st dose of study drug, then the subsequently injected 2nd dose will be increased by 25% or at least 20 microgram/kg/dose. The maximal dose of 150 microgram/kg/dose will not be exceeded. The absolute maximum dose is 20 mg. Funding Source: FDA OOPD and Watson Pharmaceuticals
NCT00124514 ↗	Triptorelin for Ovary Protection in Childhood Onset Lupus	Completed	Children's Hospital Medical Center, Cincinnati	Phase 2	2003-06-01	The purpose of this study is to test the safety of triptorelin when used for the protection of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for systemic lupus erythematosus (SLE; lupus) and to see what effects (good or bad) it has on patients. The study will be done with female patients who have been diagnosed with systemic lupus erythematosus, are younger than 21 years of age, and require intravenous cyclophosphamide to control the disease. Each patient will be in the study for approximately 23 months, until 4 months after the intravenous cyclophosphamide treatment has been completed. This study is currently being conducted at 3 sites across the United States and Brazil (Los Angeles, Cincinnati and San Paulo Brazil). A total of 50 patients will participate in this study. Each patient will be randomized (assigned) to one of 5 groups. Randomization means that patients are put into a group completely by chance. It is like flipping a coin. Neither the patient nor the study staff knows what group the patient is in. The patient has a 20% chance of being placed in any group. This is a dose escalation study, each patient will receive the first dose of the study drug (T1 - T4, placebo). If a patient has complete ovarian suppression on day 27 after the initial injection of study drug, then she will remain on this weight-adjusted dose of study drug throughout the study. The dose will be increased up for a weight gain of 5kg or greater. The dose will not be adjusted downward for a weight loss. If COS was not maintained with the 1st dose of study drug, then the subsequently injected 2nd dose will be increased by 25% or at least 20 microgram/kg/dose. The maximal dose of 150 microgram/kg/dose will not be exceeded. The absolute maximum dose is 20 mg. Funding Source: FDA OOPD and Watson Pharmaceuticals
NCT00194792 ↗	Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer	Terminated	National Cancer Institute (NCI)	Phase 2	2005-08-01	This phase II trial is studying how well giving hormone therapy together with combination chemotherapy before and after surgery works in treating patients with stage I-IIIA breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane and triptorelin pamoate may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy, such as capecitabine, methotrexate, vinorelbine ditartrate, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery
NCT00194792 ↗	Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer	Terminated	University of Washington	Phase 2	2005-08-01	This phase II trial is studying how well giving hormone therapy together with combination chemotherapy before and after surgery works in treating patients with stage I-IIIA breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane and triptorelin pamoate may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy, such as capecitabine, methotrexate, vinorelbine ditartrate, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery
NCT00564850 ↗	Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty	Completed	Ipsen	Phase 3	2007-10-01	The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection with triptorelin 11.25 mg.
NCT00909844 ↗	Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study	Completed	Ipsen	Phase 3	2008-04-01	The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.
NCT01161563 ↗	Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration	Completed	Watson Pharmaceuticals	Phase 4	2010-07-01	The purpose of this study is to compare how subjects feel after receiving injections of two different types of GnRH six months apart. One injection is given under the skin of the abdomen, and the other one into the muscle of the buttock or thigh.

Clinical Trial Conditions for Triptorelin Pamoate

Condition Name

Condition Name for Triptorelin Pamoate
Intervention	Trials
Prostate Cancer	5
Central Precocious Puberty	3
Precocious Puberty	2
Prostate Adenocarcinoma	2

Condition MeSH

Condition MeSH for Triptorelin Pamoate
Intervention	Trials
Prostatic Neoplasms	8
Puberty, Precocious	5
Adenocarcinoma	2
Schizophrenia	1

Clinical Trial Locations for Triptorelin Pamoate

Trials by Country

Trials by Country for Triptorelin Pamoate
Location	Trials
United States	42
France	3
China	2
Poland	1
Belgium	1

Trials by US State

Trials by US State for Triptorelin Pamoate
Location	Trials
California	5
New York	4
New Jersey	4
Florida	3
Washington	3

Clinical Trial Progress for Triptorelin Pamoate

Clinical Trial Phase

Clinical Trial Phase for Triptorelin Pamoate
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	8
Phase 2	5

Clinical Trial Status

Clinical Trial Status for Triptorelin Pamoate
Clinical Trial Phase	Trials
Completed	8
Terminated	3
Not yet recruiting	2

Clinical Trial Sponsors for Triptorelin Pamoate

Sponsor Name

Sponsor Name for Triptorelin Pamoate
Sponsor	Trials
Ipsen	8
National Cancer Institute (NCI)	3
Watson Pharmaceuticals	3

Sponsor Type

Sponsor Type for Triptorelin Pamoate
Sponsor	Trials
Industry	14
Other	7
NIH	3

Triptorelin Pamoate: Clinical Trials, Market Analysis, and Projections

Introduction to Triptorelin Pamoate

Triptorelin pamoate is a synthetic decapeptide and a potent agonist of the luteinizing hormone-releasing hormone (LHRH). It is widely used in the treatment of various hormone-sensitive conditions, including central precocious puberty (CPP), endometriosis, and prostate cancer. Here, we will delve into the recent clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Central Precocious Puberty (CPP)

Recent clinical trials have focused on the efficacy and safety of triptorelin pamoate in treating CPP. A 6-month trial involving patients with CPP demonstrated that triptorelin pamoate 11.25 mg, administered at 3-month intervals, is an effective and well-tolerated treatment. The study showed stable or reduced Tanner breast stages, mean uterine length, and growth velocity in patients treated with triptorelin pamoate[1].

Comparative Studies

The study also compared the results with those from a previous trial using triptorelin acetate 11.25 mg. Both formulations showed similar efficacy in suppressing LH response, oestradiol, and testosterone levels. However, the study highlighted the importance of assessing the efficacy and safety of different pharmaceutical salts, as they may have distinct pharmacological effects[1].

Other Clinical Trials

A phase III, open-label, multicentre study in Chinese pediatric participants with CPP further supported the efficacy and safety of a 6-month formulation of triptorelin. This study, though focused on a different population, aligns with the global trend of using triptorelin pamoate for managing CPP[3].

Market Analysis and Projections

Global Market Growth

The global triptorelin market is projected to experience significant growth, driven by increasing demand for treatments of hormone-sensitive conditions. The market, valued at approximately USD 955.50 million in 2023, is expected to reach USD 1556.41 million by 2033, reflecting a compound annual growth rate (CAGR) of 5% over the next decade[2].

Key Drivers

1. Endometriosis: The rising prevalence of endometriosis among women is a major driver, as triptorelin is a preferred treatment option for this condition.
2. Central Precocious Puberty: The increase in cases of CPP, particularly in children under the age of nine, is creating opportunities for the triptorelin market.
3. Cancer Treatment: Triptorelin pamoate is also used in the treatment of prostate cancer and is being studied for other types of cancer, further boosting market growth[2].

Regional Market Projections

• Europe: The European market is expected to be worth USD 370 million by 2033.
• U.S. Market: The U.S. triptorelin market was valued at US$ 171.7 million in 2022 and is expected to exhibit a CAGR of 5.5% over the forecast period (2022-2030)[4].

Route of Administration

The market share from the intradermal sector is expected to increase at a CAGR of about 4.5% from 2023 to 2033, indicating a preference for this route of administration[2].

Use in Cancer

Prostate Cancer

Triptorelin pamoate is approved for the treatment of advanced prostate cancer. It works by initially stimulating the pituitary gland to release more LH and FSH, which briefly raises testosterone levels. Continued use leads to the suppression of LH and FSH production, resulting in lower testosterone levels that help slow or stop the growth of prostate cancer cells[5].

Other Cancer Types

Triptorelin pamoate is also being studied in the treatment of other types of cancer, including its use in adjuvant hormonal therapy treatments such as Letrozole + Zoledronate, Letrozole, and Tamoxifen, particularly in breast cancer patients. These ongoing studies suggest potential future applications and growth opportunities for the drug[4].

Safety and Tolerability

Clinical trials have consistently shown that triptorelin pamoate is well-tolerated. Safety assessments in both CPP and cancer treatment studies have included clinical and biological tolerability tests, with adverse events (AEs) being monitored and recorded. The majority of AEs have been mild to moderate, indicating a favorable safety profile[1][3].

Conclusion

Triptorelin pamoate is a versatile and effective drug with a strong presence in the treatment of hormone-sensitive conditions. The ongoing clinical trials and market projections indicate a robust future for this drug, driven by increasing demand and expanding applications.

Key Takeaways

• Efficacy in CPP: Triptorelin pamoate is effective and well-tolerated in treating central precocious puberty.
• Market Growth: The global triptorelin market is projected to reach USD 1556.41 million by 2033.
• Key Drivers: Increasing prevalence of endometriosis and CPP, along with its use in cancer treatment.
• Regional Projections: Significant growth expected in Europe and the U.S. markets.
• Safety Profile: Well-tolerated with a favorable safety profile.

FAQs

What is triptorelin pamoate used for?

Triptorelin pamoate is used to treat conditions such as central precocious puberty, endometriosis, and prostate cancer by reducing hormone levels.

How does triptorelin pamoate work?

It works by initially stimulating the pituitary gland to release more LH and FSH, which briefly raises testosterone levels. Continued use leads to the suppression of LH and FSH production, resulting in lower testosterone levels.

What are the key drivers of the triptorelin market growth?

The key drivers include the increasing prevalence of endometriosis, central precocious puberty, and its use in cancer treatment.

What is the projected market value of triptorelin by 2033?

The global triptorelin market is expected to reach USD 1556.41 million by 2033.

Is triptorelin pamoate safe?

Clinical trials have shown that triptorelin pamoate is well-tolerated with a favorable safety profile, though adverse events can occur.

Sources

1. A 6-Month Trial of the Efficacy and Safety of Triptorelin Pamoate... - Karger.
2. Global Triptorelin Market Projected to Surge, Reaching USD 1556.41 Million by 2033 - PharmiWeb.
3. Clinical Trial Results: A phase III, open-label, multicentre, single arm study... - EudraCT.
4. U.S. Triptorelin Market Size, Trends and Forecast to 2028 - Coherent Market Insights.
5. Triptorelin Pamoate - National Cancer Institute.