Megestrol acetate has been evaluated in numerous clinical trials spanning Phase 1 to Phase 4, encompassing completed, active, recruiting, and terminated protocols. These studies target diverse indications, primarily advanced hormone-responsive malignancies such as breast and endometrial cancers, as well as cancer-associated anorexia-cachexia syndrome, chronic obstructive pulmonary disease, and weight loss. Spearheaded by academic medical centers, specialized tumor hospitals, and commercial sponsors, this research reflects extensive evaluation across both oncologic and supportive care management.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07436793 | RECRUITING | Endometrial Endometrioid Adenocarcinoma; Endometrial Hyperplasia |
New Mexico Cancer Research Alliance |
2026-06-15 | PHASE2 |
| NCT05255653 | RECRUITING | Endometrial Cancer |
Leiden University Medical Center |
2021-11-11 | PHASE2; PHASE3 |
| NCT06549855 | RECRUITING | Endometrial Cancer; Endometrioid Carcinoma; Mismatch Repair Deficiency |
Peking University People's Hospital |
2024-09-02 | |
| NCT07543536 | RECRUITING | Advanced/Metastatic Breast Cancer; HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer |
Sun Yat-sen University |
2026-06-08 | PHASE3 |
| NCT07477808 | NOT_YET_RECRUITING | Non-small Cell Lung Cancer |
Hunan Province Tumor Hospital |
2026-04-01 | PHASE3 |
| NCT07319429 | RECRUITING | Endometrial Cancer; Fertility |
Fudan University |
2026-01-25 | PHASE2; PHASE3 |
| NCT07408505 | RECRUITING | Advanced Pancreatic Ductal Adenocarcinoma; Cancer Anorexia-Cachexia Syndrome |
Shandong Cancer Hospital and Institute |
2026-06-01 | |
| NCT06979596 | RECRUITING | Malignant Neoplasm |
Merck Sharp & Dohme LLC |
2025-08-11 | PHASE2 |
| NCT07565415 | NOT_YET_RECRUITING | Hepatocellular Carcinoma (HCC); Cachexia; Anorexia; Malnutrition |
Nanfang Hospital, Southern Medical University |
2026-06-22 | PHASE2 |
| NCT07796789 | RECRUITING | Nasopharyngeal Cancinoma (NPC) |
Sun Yat-sen University |
2026-08-30 | PHASE3 |
| NCT07356037 | NOT_YET_RECRUITING | Cachexia; Hepatocellular Carcinoma |
Changchun GeneScience Pharmaceutical Co., Ltd. |
2026-01-10 | PHASE3 |
| NCT06963593 | NOT_YET_RECRUITING | Advanced Gastroesophageal Cancer |
Peking University |
2025-06-01 | PHASE4 |
| NCT06772428 | NOT_YET_RECRUITING | Head and Neck Squamous Cell Carcinoma; Underwent Surgery Within 6 Weeks and Postoperative Assessment Indicated High-risk Factors |
Changchun GeneScience Pharmaceutical Co., Ltd. |
2025-01-01 | PHASE3 |
| NCT06961188 | NOT_YET_RECRUITING | Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity; Untreated With Systemic Therapy |
Changchun GeneScience Pharmaceutical Co., Ltd. |
2025-06-01 | PHASE3 |
| NCT07150663 | RECRUITING | Non-small Cell Lung Cancer |
Changchun GeneScience Pharmaceutical Co., Ltd. |
2025-08-20 | PHASE3 |
| NCT05913427 | RECRUITING | Adrenocortical Carcinoma |
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia |
2022-06-08 | PHASE2 |
| NCT06998758 | RECRUITING | Neoadjuvant Chemotherapy; Weight Loss |
Sixth Affiliated Hospital, Sun Yat-sen University |
2025-11-11 | PHASE3 |
| NCT05247268 | RECRUITING | Endometrial Neoplasm Malignant Stage I |
Fudan University |
2022-03-11 | PHASE2 |
| NCT05538897 | ACTIVE_NOT_RECRUITING | FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma; FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma; Metastatic Endometrial Endometrioid Adenocarcinoma; Recurrent Endometrial Endometrioid Adenocarcinoma |
National Cancer Institute (NCI) |
2023-03-31 | PHASE1; PHASE2 |
| NCT06793228 | NOT_YET_RECRUITING | SCLC, Extensive Stage |
Henan Cancer Hospital |
2025-01-15 | PHASE2 |
| NCT07391826 | NOT_YET_RECRUITING | Stage III Gastric Cancer |
The First Affiliated Hospital with Nanjing Medical University |
2026-02-15 | PHASE2 |
| NCT06961201 | NOT_YET_RECRUITING | Extensive-stage Small Cell Lung Cancer (ES-SCLC); The Pre-cachexia or Cachexia Patients Who Have Not Received Systemic Treatment and Are Not Eligible for Curative Therapy |
Changchun GeneScience Pharmaceutical Co., Ltd. |
2025-05-01 | PHASE3 |
| NCT06828757 | NOT_YET_RECRUITING | Non Small Cell Lung Cancer |
Hunan Province Tumor Hospital |
2025-05-01 | PHASE3 |
| NCT07243379 | RECRUITING | Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia; Multicenter Observational Study |
Changchun GeneScience Pharmaceutical Co., Ltd. |
2025-09-25 | PHASE4 |
| NCT07254416 | NOT_YET_RECRUITING | Breast Cancer Patients Treated With T-DXd |
Tianjin Medical University Cancer Institute and Hospital |
2025-12-15 | PHASE4 |
| NCT07338487 | RECRUITING | Locally Advanced Cervical Cancer; Cachexia |
Second Xiangya Hospital of Central South University |
2026-04-30 | PHASE1 |
| NCT07124195 | NOT_YET_RECRUITING | Malignant Solid Tumors; Moderate to High Emetogenic Chemotherapy (MEC/HEC) Drugs |
The First Affiliated Hospital of Xinxiang Medical College |
2025-08-10 | PHASE3 |
| NCT07092137 | NOT_YET_RECRUITING | Lung Cancer; Cachexia-Anorexia Syndrome |
Guangzhou Institute of Respiratory Disease |
2025-10-10 | PHASE2 |
| NCT07246070 | NOT_YET_RECRUITING | Chemotherapy-Induced Nausea and Vomiting (CINV) |
AIPING ZHOU |
2025-12 | PHASE2 |
| NCT07130617 | NOT_YET_RECRUITING | Efficacy; Safety; Megestrol Acetate; Adult Subject |
Changchun GeneScience Pharmaceutical Co., Ltd. |
2025-09-29 | PHASE1 |
| NCT06909383 | NOT_YET_RECRUITING | Extensive-stage Small Cell Lung Cancer (ES-SCLC); Cancer - Associated Anorexia - Cachexia Syndrome |
Guangzhou Institute of Respiratory Disease |
2025-06-01 | PHASE2 |
| NCT04939090 | ACTIVE_NOT_RECRUITING | Advanced Malignant Solid Neoplasm; Anorexia; Hematopoietic and Lymphoid Cell Neoplasm |
Alliance for Clinical Trials in Oncology |
2022-01-03 | PHASE3 |
| NCT05316467 | TERMINATED | Endometrial Carcinoma; Obese; Overweight; Fertility Issues |
Xiaojun Chen |
2022-05-01 | PHASE2; PHASE3 |
| NCT05316493 | RECRUITING | Atypical Endometrial Hyperplasia; Fertility Issues; Overweight and Obesity |
Xiaojun Chen |
2022-06-13 | PHASE2; PHASE3 |
| NCT06830018 | RECRUITING | Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line Treatment |
Changchun GeneScience Pharmaceutical Co., Ltd. |
2025-01-23 | |
| NCT04683237 | WITHDRAWN | Atypical Endometrial Hyperplasia; Obese; Fertility Issues |
Xiaojun Chen |
2021-03-20 | PHASE2; PHASE3 |
| NCT04576104 | ACTIVE_NOT_RECRUITING | Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia; Endometrial Carcinoma |
Northwestern University |
2021-11-29 | PHASE2 |
| NCT06417736 | RECRUITING | Endometrial Cancer Stage I; Endometrial Hyperplasia |
Women's Hospital School Of Medicine Zhejiang University |
2023-12-01 | |
| NCT06500234 | RECRUITING | Nutrition Disorders; Immunotherapy; Cancer; Survival, Prosthesis |
Qingdao Central Hospital |
2024-06-01 | PHASE3 |
| NCT03815019 | COMPLETED | Feeding Behavior; Feeding Disorder of Infancy or Early Childhood |
University of Kansas Medical Center |
2019-08-15 | PHASE4 |
| NCT04897217 | WITHDRAWN | Endometrial Hyperplasia |
Wake Forest University Health Sciences |
2023-06-30 | PHASE3 |
| NCT05332483 | TERMINATED | Endometrial Cancer |
Sunnybrook Health Sciences Centre |
2022-07-05 | PHASE1 |
| NCT04491643 | COMPLETED | Endometrial Carcinoma Stage I |
Fudan University |
2020-09-01 | PHASE2 |
| NCT05380479 | UNKNOWN | Anorexia |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
2022-06-01 | PHASE2 |
| NCT03671811 | ACTIVE_NOT_RECRUITING | Atypical Endometrial Hyperplasia; Endometrial Carcinoma |
City of Hope Medical Center |
2019-01-21 | PHASE2 |
| NCT03306472 | COMPLETED | Breast Cancer |
Cambridge University Hospitals NHS Foundation Trust |
2017-07-20 | PHASE2 |
| NCT03963752 | COMPLETED | Idiopathic Precocious Puberty |
Children's Hospital of Fudan University |
2019-08-15 | PHASE4 |
| NCT05332483 | Terminated | Endometrial Cancer |
Sunnybrook Health Sciences Centre|Ontario Institute for Cancer Research |
2022-07-05 | Phase 1 |
| NCT04491682 | COMPLETED | Atypical Endometrial Hyperplasia |
Fudan University |
2020-09-01 | PHASE2; PHASE3 |
| NCT03283488 | COMPLETED | Cachexia; Cancer; Anorexia |
University of Sao Paulo |
2019-03-26 | PHASE2 |
| NCT04607252 | TERMINATED | Atypical Endometrial Hyperplasia |
Fudan University |
2021-01-11 | PHASE2; PHASE3 |
| NCT02269670 | TERMINATED | Estrogen Receptor-positive Breast Cancer; HER2-negative Breast Cancer; Progesterone Receptor-positive Breast Cancer; Recurrent Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer |
Emory University |
2014-11-25 | PHASE2 |
| NCT04430361 | UNKNOWN | Tumor; Chemotherapy-induced Nausea and Vomiting |
Henan Cancer Hospital |
2018-09-07 | PHASE2 |
| NCT03777930 | UNKNOWN | Cancer, Therapy-Related |
Shenzhen Fifth People's Hospital |
2018-12-10 | PHASE4 |
| NCT03241914 | COMPLETED | Endometrial Neoplasm Malignant Stage I |
Fudan University |
2017-07-04 | PHASE2; PHASE3 |
| NCT03241888 | COMPLETED | Atypical Endometrial Hyperplasia |
Fudan University |
2017-07-04 | PHASE2; PHASE3 |
| NCT03024580 | UNKNOWN | Breast Neoplasm |
Instituto Nacional de Cancer, Brazil |
2017-03-06 | PHASE2 |
| NCT02644408 | COMPLETED | Stage III Esophageal Squamous Cell Carcinoma; Stage II Esophageal Squamous Cell Carcinoma |
The First Affiliated Hospital of Henan University of Science and Technology |
2014-10-01 | PHASE3 |
| NCT01968317 | COMPLETED | Endometrial Atypical Hyperplasia; Endometrial Adenocarcinoma |
Xiaojun Chen |
2013-10 | PHASE2 |
| NCT02980653 | UNKNOWN | Head and Neck Cancer |
TTY Biopharm |
2015-05 | PHASE2 |
| NCT00729586 | COMPLETED | Endometrial Carcinoma; Recurrent Uterine Corpus Carcinoma; Stage IIIA Uterine Corpus Cancer; Stage IIIB Uterine Corpus Cancer; Stage IIIC1 Uterine Corpus Cancer; Stage IIIC2 Uterine Corpus Cancer; Stage IVA Uterine Corpus Cancer; Stage IVB Uterine Corpus Cancer |
National Cancer Institute (NCI) |
2008-09 | PHASE2 |
| NCT02619266 | UNKNOWN | Anorexia; Cancer Cachexia |
Xinqiao Hospital of Chongqing |
2015-12 | PHASE2; PHASE3 |
| NCT02595723 | COMPLETED | Cognitive Impairment |
University of Texas Southwestern Medical Center |
2015-07 | PHASE4 |
| NCT01943058 | WITHDRAWN | Atypical Endometrial Hyperplasia; Endometrial Adenocarcinoma; Recurrent Endometrial Carcinoma; Stage IA Endometrial Carcinoma; Stage IB Endometrial Carcinoma; Stage II Endometrial Carcinoma; Stage IIIA Endometrial Carcinoma; Stage IIIB Endometrial Carcinoma; Stage IIIC Endometrial Carcinoma; Stage IVA Endometrial Carcinoma; Stage IVB Endometrial Carcinoma |
University of Southern California |
2014-03 | PHASE2 |
| NCT01501396 | WITHDRAWN | Anorexia |
Washington University School of Medicine |
2013-09 | PHASE2 |
| NCT01206478 | COMPLETED | Chronic Oral Food Refusal |
Ann Davis, PhD, MPH, ABPP |
2010-08 | PHASE2 |
| NCT00483327 | COMPLETED | Atypical Endometrial Hyperplasia; Endometrial Carcinoma |
NYU Langone Health |
2007-06 | PHASE2 |
| NCT00163072 | WITHDRAWN | Cachexia |
Milton S. Hershey Medical Center |
2005-10 | PHASE4 |
| NCT00503581 | TERMINATED | High Grade Squamous Intraepithelial Neoplasia; Stage 0 Uterine Corpus Cancer |
Gynecologic Oncology Group |
2007-07 | PHASE2 |
| NCT00439101 | COMPLETED | Malnourished Children With Cancer |
University of British Columbia |
2007-04 | |
| NCT00910091 | COMPLETED | Endometrial Cancer |
Ipsen |
2009-08 | PHASE2 |
| NCT01200602 | TERMINATED | Anorexia; Weight Changes |
Mayo Clinic |
2011-03 | PHASE2 |
| NCT00739830 | COMPLETED | Endometrial Cancer |
Merck Sharp & Dohme LLC |
2008-08 | PHASE2 |
| NCT00420563 | COMPLETED | Cancer |
Centre Oscar Lambret |
2009-09-25 | PHASE2 |
| NCT00503516 | TERMINATED | Dementia |
Rottapharm Spain |
2007-06 | PHASE2; PHASE3 |
| NCT00507949 | COMPLETED | Chronic Obstructive Pulmonary Disease |
Rottapharm Spain |
2006-10 | PHASE2 |
| NCT01237327 | COMPLETED | Metastatic Breast Cancer |
Pfizer |
2001-11 | PHASE3 |
| NCT00070148 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific; Weight Changes |
Wake Forest University Health Sciences |
2004-03-01 | PHASE3 |
| NCT00066248 | COMPLETED | Brain Tumor; Central Nervous System Tumors; Cachexia; Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases; Unspecified Childhood Solid Tumor, Protocol Specific |
University of South Florida |
2003-06 | PHASE2 |
| NCT00041275 | COMPLETED | Liver Cancer |
National Medical Research Council (NMRC), Singapore |
2002-05 | PHASE3 |
| NCT00439101 | Completed | Malnourished Children With Cancer |
University of British Columbia|University of Alberta |
2007-04 | Not Applicable |
| NCT00507949 | Completed | Chronic Obstructive Pulmonary Disease |
Rottapharm Spain |
2006-10 | Phase 2 |
| NCT00637806 | TERMINATED | Anorexia; Cachexia; Weight Loss |
Par Pharmaceutical, Inc. |
2006-06 | PHASE3 |
| NCT00637728 | TERMINATED | Anorexia; Cachexia; Weight Loss |
Par Pharmaceutical, Inc. |
2006-06 | PHASE3 |
| NCT00638079 | COMPLETED | Pharmacokinetics; Bioavailability; Absorption |
Endo USA Inc., a Keenova Therapeutics Company |
2006-06 | PHASE1 |
| NCT00637403 | TERMINATED | Healthy |
Par Pharmaceutical, Inc. |
2006-05 | PHASE1 |
| NCT00637572 | COMPLETED | HIV Infections; Cachexia; Anorexia; AIDS Wasting Syndrome; HIV Wasting Syndrome |
Endo USA Inc., a Keenova Therapeutics Company |
2004-12 | PHASE2 |
| NCT00575029 | COMPLETED | Adrenal Insufficiency |
University of Arkansas |
2004-04 | |
| NCT00031707 | COMPLETED | Anorexia; Cachexia |
Alliance for Clinical Trials in Oncology |
2000-03 | PHASE3 |
| NCT00004912 | COMPLETED | Cachexia; Fatigue; Unspecified Adult Solid Tumor, Protocol Specific |
Northwestern University |
2000-01 | PHASE2 |
| NCT00016341 | TERMINATED | Endometrial Cancer |
Gynecologic Oncology Group |
2001-05 | PHASE3 |
| NCT00031785 | COMPLETED | Anorexia; Cachexia; Lung Cancer |
Wake Forest University Health Sciences |
2000-09-01 | PHASE3 |
| NCT00006799 | COMPLETED | Anorexia; Cachexia; Head and Neck Cancer; Quality of Life |
Wake Forest University Health Sciences |
2000-10-01 | PHASE3 |
| NCT00005975 | COMPLETED | Breast Cancer; Hot Flashes |
SWOG Cancer Research Network |
1998-04 | PHASE3 |
| NCT00002680 | COMPLETED | Breast Cancer |
Yale University |
1994-02 | PHASE2 |
| NCT00002300 | COMPLETED | Anorexia; Cachexia; HIV Infections |
Bristol-Myers Squibb |
PHASE2 | |
| NCT00002067 | COMPLETED | Anorexia; Cachexia; HIV Infections |
Bristol-Myers Squibb |
PHASE3 | |
| NCT00004664 | COMPLETED | Acquired Immunodeficiency Syndrome; HIV Wasting Syndrome; HIV Infections |
National Center for Research Resources (NCRR) |
1995-06 | |
| NCT00001079 | COMPLETED | HIV Infections; HIV Wasting Syndrome |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00002465 | UNKNOWN | Breast Cancer; Endometrial Cancer; Malignant Mesothelioma |
St. Vincent Medical Center - Los Angeles |
1987-12 | PHASE1; PHASE2 |
| NCT00002182 | COMPLETED | HIV Infections |
Gamma Project - ACTU |
||
| NCT00002345 | COMPLETED | Anorexia; Cachexia; HIV Infections |
Bristol-Myers Squibb |
PHASE4 | |
| NCT00000737 | COMPLETED | Cachexia; HIV Infections; HIV Wasting Syndrome |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-07-02)
Check the
Megestrol Acetate
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.