CLINICAL TRIALS PROFILE FOR NANDROLONE DECANOATE

505(b)(2) Clinical Trials for Nandrolone Decanoate

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 Indication	NCT05978206 ↗	Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet	Recruiting	Medical Research Agency, Poland	Phase 2	2023-08-10	This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive physiotherapy and nutritional intervention phase II clinical trial to determine the usefulness of nandrolone decanoate in a new indication (sarcopenia). Patients will be randomized 1:1 to receive nandrolone decanoate (50 mg intramuscular injection over four visits every 3 weeks) or placebo (1 ml volume equivalent to 50 mg intramuscular nandrolone decanoate dose) for 12 weeks (83-85 days ). Both groups will receive comprehensive physiotherapy and nutritional intervention. There will be 5 outpatient visits to the research center. The procedures and assessments performed as part of the study are listed in the study schedule. It is planned to include 168 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 152 patients (76 in each arm). The study will cover people aged over 60 to 99 years of age with confirmed muscle weakness measured with a hand dynamometer (< 27 kg for men and 16 kg for women) and with a decrease in: muscle mass of upper and lower limbs (ASMM) (7.0 kg/m2 height in men and 5.5 kg/m2 in women) or total muscle mass of the upper and lower extremities (< 20 kg in men and < 15 kg in women) by densitometry.
New Indication	NCT05978206 ↗	Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet	Recruiting	National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland	Phase 2	2023-08-10	This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive physiotherapy and nutritional intervention phase II clinical trial to determine the usefulness of nandrolone decanoate in a new indication (sarcopenia). Patients will be randomized 1:1 to receive nandrolone decanoate (50 mg intramuscular injection over four visits every 3 weeks) or placebo (1 ml volume equivalent to 50 mg intramuscular nandrolone decanoate dose) for 12 weeks (83-85 days ). Both groups will receive comprehensive physiotherapy and nutritional intervention. There will be 5 outpatient visits to the research center. The procedures and assessments performed as part of the study are listed in the study schedule. It is planned to include 168 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 152 patients (76 in each arm). The study will cover people aged over 60 to 99 years of age with confirmed muscle weakness measured with a hand dynamometer (< 27 kg for men and 16 kg for women) and with a decrease in: muscle mass of upper and lower limbs (ASMM) (7.0 kg/m2 height in men and 5.5 kg/m2 in women) or total muscle mass of the upper and lower extremities (< 20 kg in men and < 15 kg in women) by densitometry.

All Clinical Trials for Nandrolone Decanoate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000597 ↗	Multi-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic Disorders	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1982-03-01	To determine the therapeutic effects of anti-thymocyte globulin (ATG) in patients with aplastic anemia and related bone marrow failure diseases.
NCT00000854 ↗	A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting). Wasting has become an AIDS-defining condition. In the past, most studies that examined wasting treatments were limited to men. However, it appears that wasting in HIV-positive men is linked to levels of testosterone (a hormone which affects men's bodies more than women's). This study has been designed for women only, in order to best treat wasting in HIV-positive women.
NCT00250536 ↗	Anabolic Steroids and Exercise in Hemodialysis Patients	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A	2000-03-01	This is a study to find out whether an exercise program during dialysis or a drug called nandrolone decanoate can increase muscle size and strenght in patients on dialysis.
NCT00260143 ↗	Testosterone and Physical Function in HIV+ Men	Completed	Charles Drew University of Medicine and Science	Phase 2	2003-05-01	Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).
NCT00260143 ↗	Testosterone and Physical Function in HIV+ Men	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2003-05-01	Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).

Clinical Trial Conditions for Nandrolone Decanoate

Condition Name

Condition Name for Nandrolone Decanoate
Intervention	Trials
Cachexia; Cancer	1
Muscle Weakness	1
Development	1
Pancytopenia	1

Condition MeSH

Condition MeSH for Nandrolone Decanoate
Intervention	Trials
Cachexia	2
Pancytopenia	2
Weight Loss	2
Anemia, Aplastic	2

Clinical Trial Locations for Nandrolone Decanoate

Trials by Country

Trials by Country for Nandrolone Decanoate
Location	Trials
United States	14
Brazil	2
Czechia	1
Denmark	1
Poland	1

Trials by US State

Trials by US State for Nandrolone Decanoate
Location	Trials
California	2
Pennsylvania	1
Ohio	1
North Carolina	1
New York	1

Clinical Trial Progress for Nandrolone Decanoate

Clinical Trial Phase

Clinical Trial Phase for Nandrolone Decanoate
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Nandrolone Decanoate
Clinical Trial Phase	Trials
Completed	7
Recruiting	3
Unknown status	1

Clinical Trial Sponsors for Nandrolone Decanoate

Sponsor Name

Sponsor Name for Nandrolone Decanoate
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2
Conselho Nacional de Desenvolvimento Científico e Tecnológico	1
University of Sao Paulo	1

Sponsor Type

Sponsor Type for Nandrolone Decanoate
Sponsor	Trials
Other	10
NIH	4

Nandrolone Decanoate: Clinical Trials, Market Analysis, and Projections

Introduction

Nandrolone decanoate, a widely used anabolic steroid, has been the subject of extensive clinical trials and market analysis due to its diverse applications in medical and sports fields. This article will delve into the clinical trials, market analysis, and future projections of nandrolone decanoate.

Clinical Trials: Anabolic Effects and Safety

Trial on Dialysis Patients

A randomized, double-blind, placebo-controlled trial conducted between 1996 and 1997 evaluated the effects of nandrolone decanoate on lean body mass (LBM), functional status, and quality of life in dialysis patients. The study found that nandrolone decanoate significantly increased LBM and improved functional status, including grip strength and walking and stair-climbing times, compared to the placebo group[1].

Trial on HIV-Infected Men

Another trial involved HIV-infected men with mild to moderate weight loss. The study compared the effectiveness of a biweekly regimen of 150 mg nandrolone decanoate with placebo. Results showed that nandrolone decanoate was associated with greater increases in LBM, fat-free mass, and body cell mass compared to the placebo group. Additionally, nandrolone improved perception of health and sexual function[4].

Medical Indications and Uses

Management of Anemia

Nandrolone decanoate is indicated in the management of anemia associated with renal insufficiency. It helps in increasing red blood cell production, thereby alleviating symptoms of anemia[3].

Osteoporosis Treatment

In Canada, nandrolone decanoate is also used as an adjunct therapy in the treatment of senile and postmenopausal osteoporosis, helping to improve bone density and reduce the risk of fractures[3].

Market Analysis

Current Market Size and Growth

The global nandrolone decanoate market was valued at USD 100 billion in 2023 and is projected to reach USD 140.71 billion by 2031, growing at a compound annual growth rate (CAGR) of 5% from 2024 to 2031. This growth is driven by increasing demand from both medical and sports industries[2].

Market Segmentation

The market is segmented based on type (injectable grade, pharmaceutical grade, research grade) and application (anabolic steroids, muscle building, hormone therapy, sports medicine). Geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa are also key segments[2].

Driving Factors

The market expansion is fueled by several factors, including the medicinal uses of nandrolone decanoate in treating chronic illnesses and muscular atrophy. The global trend of increased fitness awareness and the need for performance-enhancing medications also contribute to the growth. Advances in pharmaceutical technology, regulatory approvals, and rising healthcare costs further support market dynamics[2].

Market Projections

Future Growth

The nandrolone decanoate market is expected to continue growing due to ongoing research into new therapeutic avenues and increasing consumer awareness. The demand for both performance-enhancing and medicinal products is anticipated to rise, driven by global health and fitness trends[2].

Emerging Players and Innovations

The market report highlights both established and emerging players, providing insights into their market entry, product offerings, and various market-related factors. Innovations in pharmaceutical formulations and drug delivery methods are expected to enhance the efficacy and attractiveness of nandrolone decanoate[2].

Adverse Effects and Safety Considerations

Common Adverse Effects

Clinical trials and pharmacological studies have identified several adverse effects associated with nandrolone decanoate, including hematoma at the injection site, skin rash, and changes in serum creatinine levels indicating increased muscle mass. There are also reports of reduced testicular size and other minor adverse effects[1][3].

Contraindications and Black Box Warnings

Nandrolone decanoate has specific contraindications and black box warnings, particularly related to its potential for causing liver damage and other serious health issues. These need to be carefully considered in clinical practice[3].

Key Takeaways

• Clinical Efficacy: Nandrolone decanoate has been shown to increase lean body mass, improve functional status, and enhance quality of life in various patient populations.
• Market Growth: The global market for nandrolone decanoate is projected to grow significantly, driven by medical and sports demands.
• Medical Indications: It is used in the management of anemia, osteoporosis, and other conditions.
• Adverse Effects: While generally well-tolerated, nandrolone decanoate can cause several adverse effects that need careful monitoring.

FAQs

What are the primary medical indications for nandrolone decanoate?

Nandrolone decanoate is primarily indicated for the management of anemia associated with renal insufficiency and as an adjunct therapy in the treatment of senile and postmenopausal osteoporosis[3].

How does nandrolone decanoate affect lean body mass?

Clinical trials have shown that nandrolone decanoate significantly increases lean body mass in patients, particularly in those undergoing dialysis and HIV-infected men with weight loss[1][4].

What is the projected market size of nandrolone decanoate by 2031?

The global nandrolone decanoate market is expected to reach USD 140.71 billion by 2031, growing at a CAGR of 5% from 2024 to 2031[2].

What are the common adverse effects of nandrolone decanoate?

Common adverse effects include hematoma at the injection site, skin rash, changes in serum creatinine levels, and reduced testicular size[1][3].

How is nandrolone decanoate administered?

Nandrolone decanoate is typically administered via intramuscular injection, with doses ranging from 50 mg to 150 mg depending on the clinical indication[3].

Sources

1. JAMA Network: Anabolic Effects of Nandrolone Decanoate in Patients Receiving Dialysis.
2. Market Research Intellect: Nandrolone Decanoate Market Size, Share, Trends, Analysis, 2031.
3. DrugBank: Nandrolone decanoate: Uses, Interactions, Mechanism of Action.
4. Journal of Clinical Endocrinology and Metabolism: Randomized, Placebo-Controlled Trial of Nandrolone Decanoate in HIV-Infected Men.