You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

CLINICAL TRIALS PROFILE FOR NANDROLONE DECANOATE


✉ Email this page to a colleague

« Back to Dashboard


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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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).
>Trial ID >Title >Status >Phase >Start Date >Summary

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
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for NANDROLONE DECANOATE
Intervention Trials
Cachexia 2
Pancytopenia 2
Weight Loss 2
Anemia, Aplastic 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for NANDROLONE DECANOATE

Trials by Country

Trials by Country for NANDROLONE DECANOATE
Location Trials
United States 14
Brazil 2
Poland 1
Puerto Rico 1
Netherlands 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for NANDROLONE DECANOATE
Location Trials
California 2
Massachusetts 1
Maryland 1
Louisiana 1
Illinois 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for NANDROLONE DECANOATE
Clinical Trial Phase Trials
Completed 7
Recruiting 3
Unknown status 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
Charles Drew University of Medicine and Science 1
Conselho Nacional de Desenvolvimento Científico e Tecnológico 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for NANDROLONE DECANOATE
Sponsor Trials
Other 10
NIH 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.