CLINICAL TRIALS PROFILE FOR MEGESTROL ACETATE

All Clinical Trials for Megestrol Acetate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000737 ↗	A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome	Completed	Bristol-Myers Squibb	Phase 1	1969-12-31	To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain, appetite increase and quality of life in this patient population. To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination. HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
NCT00000737 ↗	A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome	Completed	Roxane Laboratories	Phase 1	1969-12-31	To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain, appetite increase and quality of life in this patient population. To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination. HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
NCT00000737 ↗	A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain, appetite increase and quality of life in this patient population. To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination. HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
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.
NCT00001079 ↗	A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To test the hypothesis that the predominant accrual of fat rather than lean body mass (LBM) that occurs during treatment of HIV-associated wasting with megestrol acetate may be improved by treatment with megestrol acetate and testosterone enanthate in combination. Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss. However, the weight gained during treatment with megestrol acetate was predominantly or exclusively fat. An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and a decrease in LBM. Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy. This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism.

Clinical Trial Conditions for Megestrol Acetate

Condition Name

Condition Name for Megestrol Acetate
Intervention	Trials
Anorexia	15
Cachexia	13
Atypical Endometrial Hyperplasia	9
HIV Infections	9

Condition MeSH

Condition MeSH for Megestrol Acetate
Intervention	Trials
Cachexia	19
Wasting Syndrome	18
Endometrial Neoplasms	16
Anorexia	15

Clinical Trial Locations for Megestrol Acetate

Trials by Country

Trials by Country for Megestrol Acetate
Location	Trials
United States	221
Canada	15
China	14
South Africa	5
United Kingdom	3

Trials by US State

Trials by US State for Megestrol Acetate
Location	Trials
California	16
North Carolina	14
Illinois	12
Florida	11
Pennsylvania	11

Clinical Trial Progress for Megestrol Acetate

Clinical Trial Phase

Clinical Trial Phase for Megestrol Acetate
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	15
Phase 2/Phase 3	11

Clinical Trial Status

Clinical Trial Status for Megestrol Acetate
Clinical Trial Phase	Trials
Completed	33
Recruiting	16
Terminated	7

Clinical Trial Sponsors for Megestrol Acetate

Sponsor Name

Sponsor Name for Megestrol Acetate
Sponsor	Trials
National Cancer Institute (NCI)	17
Fudan University	7
Bristol-Myers Squibb	4

Sponsor Type

Sponsor Type for Megestrol Acetate
Sponsor	Trials
Other	82
Industry	25
NIH	21

Megestrol Acetate: Clinical Trials, Market Analysis, and Projections

Introduction to Megestrol Acetate

Megestrol acetate is a synthetic progestin that has multiple clinical applications, including the stimulation of appetite in individuals with weight loss due to long-term illnesses like AIDS or cancer, and as a hormonal therapy for advanced endometrial and breast cancers. Here, we will delve into the current clinical trials, market analysis, and future projections for megestrol acetate.

Clinical Trials

PIONEER Trial for Breast Cancer

The PIONEER trial, although no longer recruiting patients, aimed to compare the efficacy of letrozole alone versus letrozole combined with megestrol acetate in postmenopausal women with estrogen receptor-positive breast cancer. This phase 2 trial randomized women into three treatment groups: letrozole alone, letrozole with a low dose of megestrol acetate, and letrozole with a high dose of megestrol acetate. The primary goal was to determine if the combination of megestrol acetate and letrozole is more effective than letrozole alone before surgery[1].

Trial on Uterine Pre-Cancer

A current phase II trial sponsored by the National Cancer Institute (NCI) is investigating the effect of megestrol acetate alone or in combination with metformin in preventing the progression of uterine pre-cancer (endometrial intraepithelial neoplasia) to endometrial cancer. This trial assesses whether adding metformin to megestrol acetate enhances the treatment's efficacy in suppressing the growth of endometrial intraepithelial neoplasia[4].

Market Analysis

Market Size and Growth

The megestrol acetate market is anticipated to grow significantly over the coming years. In 2024, the market was valued at USD xx million and is projected to grow at a compound annual growth rate (CAGR) of xx% until 2034. The market is driven by increasing cancer incidence, advancements in medical technology, and supportive healthcare policies, particularly in regions like Europe and the Asia-Pacific[2][5].

Regional Market Dynamics

• Europe: The European market is propelled by increasing cancer rates and advancements in medical technology. However, diverse healthcare systems and reimbursement structures across different countries present challenges.
• Asia-Pacific: This region is expected to be the fastest-growing segment due to expanding healthcare access, increasing cancer rates, and rising investments in healthcare infrastructure. Despite this growth, economic disparities and uneven healthcare infrastructure development can impact market uniformity[2].

Key Market Players

The megestrol acetate market is dominated by several large companies, including Par Pharmaceutical, Teva Pharmaceuticals, Hi-tech Pharmacal (Akorn), Nanjing Cuccess Pharmaceutical, and Xianju Pharma. These companies play a significant role in the production and distribution of megestrol acetate, influencing market trends and growth[2][5].

Market Segmentation

The megestrol acetate market is segmented based on various factors:

• By Indication: The market is categorized into cancer treatment, appetite stimulant, and hormonal therapy. The cancer treatment segment accounts for the largest share, approximately 69% in 2024[2].
• By End-user: The market is segmented into hospitals, clinics, cancer treatment centers, homecare settings, and others. Each segment has its own growth trajectory based on the demand for megestrol acetate in different healthcare settings[2].

Side Effects and Safety Profile

Megestrol acetate is associated with several side effects, particularly when used for extended periods. Common side effects include increased appetite and weight gain, hot flushes, rounded face, high blood pressure, raised blood sugar levels, constipation, shortness of breath, and blood clots in the lungs or veins. However, in short-term use, such as in the PIONEER trial, the risk of these side effects is considered lower[1][2].

Economic and Cost-Effectiveness Analysis

A cost-effectiveness analysis comparing megestrol acetate with exemestane in patients with advanced breast carcinoma showed that exemestane significantly delayed tumor progression and prolonged survival. However, the economic implications varied based on the treatment's efficacy and the average wholesale prices of the drugs[3].

Future Projections

Market Growth

The megestrol acetate market is expected to continue its growth trajectory driven by increasing demand for cancer treatments and appetite stimulants. The Asia-Pacific region is anticipated to be a key driver of this growth due to its expanding healthcare access and rising cancer rates[2][5].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as economic disparities and uneven healthcare infrastructure development, particularly in the Asia-Pacific region. However, advancements in medical technology and supportive healthcare policies are expected to create opportunities for market expansion[2].

Key Takeaways

• Clinical Trials: Ongoing and completed trials are evaluating the efficacy of megestrol acetate in various clinical settings, including breast cancer and uterine pre-cancer.
• Market Growth: The megestrol acetate market is projected to grow significantly, driven by increasing cancer incidence and advancements in medical technology.
• Regional Dynamics: Europe and the Asia-Pacific region are key markets, with the latter expected to be the fastest-growing segment.
• Side Effects: The drug is associated with several side effects, but short-term use may mitigate these risks.
• Economic Analysis: Cost-effectiveness studies highlight the importance of considering both efficacy and economic implications when choosing between different treatments.

FAQs

What is megestrol acetate used for?

Megestrol acetate is used to stimulate appetite in individuals with weight loss due to long-term illnesses like AIDS or cancer, and as a hormonal therapy for advanced endometrial and breast cancers.

What are the common side effects of megestrol acetate?

Common side effects include increased appetite and weight gain, hot flushes, rounded face, high blood pressure, raised blood sugar levels, constipation, shortness of breath, and blood clots in the lungs or veins.

Which regions are driving the growth of the megestrol acetate market?

The Asia-Pacific region is expected to be the fastest-growing segment, followed by Europe, driven by increasing cancer rates and advancements in medical technology.

What are the key market players in the megestrol acetate market?

Key players include Par Pharmaceutical, Teva Pharmaceuticals, Hi-tech Pharmacal (Akorn), Nanjing Cuccess Pharmaceutical, and Xianju Pharma.

What is the current status of clinical trials involving megestrol acetate?

Several clinical trials are ongoing or have been completed, including the PIONEER trial for breast cancer and a phase II trial for preventing the progression of uterine pre-cancer.

Sources

1. Cancer Research UK: A trial of megestrol acetate and letrozole for women with breast cancer (PIONEER).
2. We Market Research: Megestrol Acetate Market Size, Scope, Insights & Forecast 2034.
3. PubMed: Cost-effectiveness analysis of exemestane compared with megestrol acetate in patients with advanced breast carcinoma.
4. ClinicalTrials.gov: Megestrol Acetate Compared With Megestrol Acetate and Metformin in Preventing the Progression of Uterine Pre-Cancer.
5. EIN Presswire: Global Megestrol Acetate Market latest Analysis Of Key Players and Growth Forecast By 2030.