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Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss

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ClinicalTrials.gov Identifier: NCT00637572
Recruitment Status : Completed
First Posted : March 18, 2008
Results First Posted : April 20, 2016
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV Infections
Cachexia
Anorexia
AIDS Wasting Syndrome
HIV Wasting Syndrome
Interventions Drug: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL
Drug: Megestrol acetate oral suspension 40 mg/mL
Enrollment 63

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Megestrol Acetate Oral Suspension Nanocrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Hide Arm/Group Description Subjects were treated with 575 mg per day as single-dose for 12 weeks Subjects were treated with 800 mg per day as single-dose for 12 weeks
Period Title: Overall Study
Started 32 31
Completed 29 24
Not Completed 3 7
Reason Not Completed
Adverse Event             1             2
Death             0             1
Lost to Follow-up             0             1
Physician Decision             1             1
Withdrawal by Subject             0             2
Illicit Drug Use             1             0
Arm/Group Title Megestrol Acetate Oral Suspension Nanocrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation Total
Hide Arm/Group Description Subjects were treated with 575 mg per as single-dose for 12 weeks Subjects were treated with 800 mg per as single-dose for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 32 31 63
Hide Baseline Analysis Population Description
Analysis based on Intend to Treat (ITT) population; all randomized subjects who were dispensed medication and had at least one post-randomization visit.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 31 participants 63 participants
37.3  (7.32) 36.3  (7.22) 36.8  (7.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 31 participants 63 participants
Female
11
  34.4%
16
  51.6%
27
  42.9%
Male
21
  65.6%
15
  48.4%
36
  57.1%
1.Primary Outcome
Title Change in Body Weight
Hide Description Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment
Time Frame Baseline (Day 1) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit
Arm/Group Title Megestrol Acetate Oral Suspension Nanocrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Hide Arm/Group Description:
Subjects were treated with 575 mg per day as single-dose for 12 weeks
Subjects were treated with 800 mg per day as single-dose for 12 weeks
Overall Number of Participants Analyzed 32 31
Mean (Standard Deviation)
Unit of Measure: kg
Overall 5.4  (5.32) 3.5  (4.03)
Male 7.0  (3.16) 3.5  (4.72)
Female 2.3  (7.18) 3.5  (3.42)
2.Secondary Outcome
Title Change From Baseline in Lean Mass
Hide Description [Not Specified]
Time Frame Baseline (Day 1) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.
Arm/Group Title Megestrol Acetate Oral Suspension Nanocrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Hide Arm/Group Description:
Subjects were treated with 575 mg per day as single-dose for 12 weeks
Subjects were treated with 800 mg per day as single-dose for 12 weeks
Overall Number of Participants Analyzed 31 31
Mean (Standard Deviation)
Unit of Measure: kg
2.1  (3.74) 1.3  (2.82)
3.Secondary Outcome
Title Change From Baseline in Impedance
Hide Description Electrical impedance is a method for body composition assessment. The procedure involves sending a small current through the body and measuring the resistance in ohm. High resistance is associated with smaller amounts of fat-free mass. Smaller resistance is associated with large amounts of fat-free mass.
Time Frame Baseline (Day 1) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.
Arm/Group Title Megestrol Acetate Oral Suspension Nanocrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Hide Arm/Group Description:
Subjects were treated with 575 mg per day as single-dose for 12 weeks
Subjects were treated with 800 mg per day as single-dose for 12 weeks
Overall Number of Participants Analyzed 31 31
Mean (Standard Deviation)
Unit of Measure: ohms
21.6  (77.2) 12.2  (54.2)
4.Secondary Outcome
Title Change From Baseline in Body Fat Mass
Hide Description [Not Specified]
Time Frame Baseline (Day 1) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.
Arm/Group Title Megestrol Acetate Oral Suspension Nanocrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Hide Arm/Group Description:
Subjects were treated with 575 mg per day as single-dose for 12 weeks
Subjects were treated with 800 mg per day as single-dose for 12 weeks
Overall Number of Participants Analyzed 31 31
Mean (Standard Deviation)
Unit of Measure: kg
3.2  (4.1) 2.2  (3.4)
5.Secondary Outcome
Title Change in Hip Circumference
Hide Description [Not Specified]
Time Frame Baseline (Day 1) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects and 29 subjects were analyzed, respectively based on available baseline measurements.
Arm/Group Title Megestrol Acetate Oral Suspension Nanocrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Hide Arm/Group Description:
Subjects were treated with 575 mg per day as single-dose for 12 weeks
Subjects were treated with 800 mg per day as single-dose for 12 weeks
Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: cm
2.5  (3.7) 1.8  (3.6)
6.Secondary Outcome
Title Change in Waist Circumference
Hide Description [Not Specified]
Time Frame Baseline (Day 1) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available data measurements.
Arm/Group Title Megestrol Acetate Oral Suspension Nanocrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Hide Arm/Group Description:
Subjects were treated with 575 mg per day as single-dose for 12 weeks
Subjects were treated with 800 mg per day as single-dose for 12 weeks
Overall Number of Participants Analyzed 32 31
Mean (Standard Deviation)
Unit of Measure: cm
7.1  (4.9) 5.4  (4.7)
7.Secondary Outcome
Title Change in Tricep Skinfold
Hide Description [Not Specified]
Time Frame Baseline (Day 1) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit
Arm/Group Title Megestrol Acetate Oral Suspension Nanocrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Hide Arm/Group Description:
Subjects were treated with 575 mg per day as single-dose for 12 weeks
Subjects were treated with 800 mg per day as single-dose for 12 weeks
Overall Number of Participants Analyzed 32 31
Mean (Standard Deviation)
Unit of Measure: cm
1.0  (2.6) 1.5  (5.4)
8.Secondary Outcome
Title Change in Mid-arm Circumference
Hide Description [Not Specified]
Time Frame Baseline (Day 1) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit
Arm/Group Title Megestrol Acetate Oral Suspension Nanocrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Hide Arm/Group Description:
Subjects were treated with 575 mg per day as single-dose for 12 weeks
Subjects were treated with 800 mg per day as single-dose for 12 weeks
Overall Number of Participants Analyzed 32 31
Mean (Standard Deviation)
Unit of Measure: cm
-0.6  (11.5) 1.1  (1.5)
9.Secondary Outcome
Title Change in Total Energy
Hide Description Food intake was quantified by the 24-hour recall food diary
Time Frame Baseline (Day 1) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 27 subjects and 22 subjects were analyzed, respectively based on available baseline data.
Arm/Group Title Megestrol Acetate Oral Suspension Nanocrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Hide Arm/Group Description:
Subjects were treated with 575 mg per day as single-dose for 12 weeks
Subjects were treated with 800 mg per day as single-dose for 12 weeks
Overall Number of Participants Analyzed 27 22
Mean (Standard Deviation)
Unit of Measure: kcal
215.9  (830.3) 150.6  (1044.1)
10.Secondary Outcome
Title Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI)
Hide Description The BACRI instrument is used to measure the benefit of weight gain treatment provided to anorexic patients on health related quality of life aspects. The scale is composed of 9 subscales (0 to 10 [worse to better]). The response was captured on a VAS scale in cm. The total BACRI score is the sum with a minimum score 0=worse and maximum score 90=better. These subscales are: change in weight impacting health; concern about weight; appearance change; change feeling of appearance; change in appetite; enjoy eating; overall feeling; benefit of treatment; and quality of life.
Time Frame Baseline (Day 3) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 29 subjects were analyzed in the micronized formulation treatment group based on available baseline measurements.
Arm/Group Title Megestrol Acetate Oral Suspension Nanocrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Hide Arm/Group Description:
Subjects were treated with 575 mg per day as single-dose for 12 weeks
Subjects were treated with 800 mg per day as single-dose for 12 weeks
Overall Number of Participants Analyzed 32 29
Mean (Standard Deviation)
Unit of Measure: cm
Baseline (Day 3) 52.3  (9.38) 50.1  (7.31)
Week 12 67.6  (9.53) 65.6  (14.78)
11.Secondary Outcome
Title Appetite at Baseline (Day 3) and Week 12
Hide Description Appetite was assessed via visual analogue scale (VAS) as part of the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) (Question 5 only). The question was "To what extent has your appetite changed since the start of treatment?" The response was captured on a VAS scale in cm with a range from 0 ( "much worse") to 10 ("much better").
Time Frame Baseline (Day 3) to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 29 subjects were analyzed in the micronized formulation treatment group based on available baseline measurements.
Arm/Group Title Megestrol Acetate Oral Suspension Nanocrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Hide Arm/Group Description:
Subjects were treated with 575 mg per day as single-dose for 12 weeks
Subjects were treated with 800 mg per day as single-dose for 12 weeks
Overall Number of Participants Analyzed 32 29
Mean (Standard Deviation)
Unit of Measure: cm
Baseline Day 3 6.1  (1.81) 5.8  (1.16)
Week 12 8.4  (1.30) 8.0  (2.14)
Time Frame Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Megestrol Acetate Oral Suspension NanoCrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Hide Arm/Group Description Subjects were treated with 575 mg per day as single dose for 12 weeks Subjects were treated with 800 mg per day as single dose for 12 weeks
All-Cause Mortality
Megestrol Acetate Oral Suspension NanoCrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Megestrol Acetate Oral Suspension NanoCrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/32 (43.75%)      14/31 (45.16%)    
Blood and lymphatic system disorders     
Anaemia * 1  0/32 (0.00%)  0 2/31 (6.45%)  2
Cardiac disorders     
Cardiac failure congestive * 1  1/32 (3.13%)  1 2/31 (6.45%)  2
Endocrine disorders     
Adrenal insufficiency * 1  3/32 (9.38%)  3 4/31 (12.90%)  4
Adrenal suppression * 1  2/32 (6.25%)  2 2/31 (6.45%)  2
General disorders     
Asthenia * 1  0/32 (0.00%)  0 1/31 (3.23%)  1
Death of unknown cause * 1  0/32 (0.00%)  0 1/31 (3.23%)  1
Oedema peripheral * 1  0/32 (0.00%)  0 1/31 (3.23%)  1
Infections and infestations     
Adrenal gland tuberculosis * 1  0/32 (0.00%)  0 1/31 (3.23%)  1
Diarrhoea infectious * 1  1/32 (3.13%)  1 0/31 (0.00%)  0
Gastroenteritis * 1  0/32 (0.00%)  0 1/31 (3.23%)  1
HIV infection * 1  0/32 (0.00%)  0 1/31 (3.23%)  1
Meningitis tuberculous * 1  0/32 (0.00%)  0 1/31 (3.23%)  1
Pneumocystis jiroveci pneumonia * 1  1/32 (3.13%)  1 0/31 (0.00%)  0
Pneumonia * 1  0/32 (0.00%)  0 1/31 (3.23%)  1
Pulmonary tuberculosis * 1  0/32 (0.00%)  0 2/31 (6.45%)  2
Investigations     
Blood cortisol abnormal * 1  6/32 (18.75%)  6 3/31 (9.68%)  3
Blood cortisol decreased * 1  2/32 (6.25%)  2 0/31 (0.00%)  0
Venous pressure jugular increased * 1  0/32 (0.00%)  0 1/31 (3.23%)  1
Metabolism and nutrition disorders     
Lactic acidosis * 1  0/32 (0.00%)  0 1/31 (3.23%)  1
Musculoskeletal and connective tissue disorders     
Pain in extremity * 1  0/32 (0.00%)  0 1/31 (3.23%)  1
Nervous system disorders     
Cerebral infarction * 1  1/32 (3.13%)  1 0/31 (0.00%)  0
Demyelinating polyneuropathy * 1  0/32 (0.00%)  0 1/31 (3.23%)  1
Reproductive system and breast disorders     
Amenorrhoea * 1  0/32 (0.00%)  0 1/31 (3.23%)  1
Vascular disorders     
Deep vein thrombosis * 1  0/32 (0.00%)  0 1/31 (3.23%)  1
Hypertension * 1  1/32 (3.13%)  2 0/31 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Megestrol Acetate Oral Suspension NanoCrystal Dispersion Megestrol Acetate Oral Suspension Micronized Formulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/32 (93.75%)      30/31 (96.77%)    
Blood and lymphatic system disorders     
Anaemia * 1  3/32 (9.38%)  0/31 (0.00%) 
Eosinophilia * 1  0/32 (0.00%)  2/31 (6.45%) 
Cardiac disorders     
Cardiac failure congestive * 1  3/32 (9.38%)  2/31 (6.45%) 
Endocrine disorders     
Adrenal insufficiency * 1  4/32 (12.50%)  8/31 (25.81%) 
Adrenal suppression * 1  4/32 (12.50%)  2/31 (6.45%) 
Cushingoid * 1  2/32 (6.25%)  0/31 (0.00%) 
Gastrointestinal disorders     
Abdominal distension * 1  1/32 (3.13%)  2/31 (6.45%) 
Abdominal pain * 1  3/32 (9.38%)  2/31 (6.45%) 
Constipation * 1  3/32 (9.38%)  1/31 (3.23%) 
Diarrhoea * 1  2/32 (6.25%)  4/31 (12.90%) 
Dyspepsia * 1  6/32 (18.75%)  2/31 (6.45%) 
Flatulence * 1  3/32 (9.38%)  0/31 (0.00%) 
Gastritis * 1  2/32 (6.25%)  0/31 (0.00%) 
Nausea * 1  2/32 (6.25%)  3/31 (9.68%) 
Vomiting * 1  0/32 (0.00%)  4/31 (12.90%) 
General disorders     
Asthenia * 1  5/32 (15.63%)  0/31 (0.00%) 
Non-cardiac chest pain * 1  1/32 (3.13%)  3/31 (9.68%) 
Oedema peripheral * 1  1/32 (3.13%)  3/31 (9.68%) 
Pyrexia * 1  2/32 (6.25%)  4/31 (12.90%) 
Infections and infestations     
Bronchitis * 1  2/32 (6.25%)  1/31 (3.23%) 
Gastroenteritis * 1  2/32 (6.25%)  3/31 (9.68%) 
Nasopharyngitis * 1  2/32 (6.25%)  1/31 (3.23%) 
Pharyngitis * 1  1/32 (3.13%)  2/31 (6.45%) 
Upper respiratory tract infection * 1  0/32 (0.00%)  4/31 (12.90%) 
Urinary tract infection * 1  3/32 (9.38%)  1/31 (3.23%) 
Injury, poisoning and procedural complications     
Excoriation * 1  2/32 (6.25%)  0/31 (0.00%) 
Investigations     
Alanine aminotransferase increased * 1  2/32 (6.25%)  2/31 (6.45%) 
Aspartate aminotransferase increased * 1  1/32 (3.13%)  2/31 (6.45%) 
Blood cholesterol increased * 1  3/32 (9.38%)  1/31 (3.23%) 
Blood cortisol abnormal * 1  4/32 (12.50%)  2/31 (6.45%) 
Blood cortisol decreased * 1  3/32 (9.38%)  4/31 (12.90%) 
Blood glucose increased * 1  1/32 (3.13%)  2/31 (6.45%) 
Blood lactate dehydrogenase increased * 1  12/32 (37.50%)  5/31 (16.13%) 
Blood triglycerides increased * 1  2/32 (6.25%)  1/31 (3.23%) 
Cardiac murmur * 1  3/32 (9.38%)  1/31 (3.23%) 
Low density lipoprotein increased * 1  3/32 (9.38%)  0/31 (0.00%) 
Mean cell haemoglobin increased * 1  5/32 (15.63%)  5/31 (16.13%) 
Mean cell volume increased * 1  8/32 (25.00%)  5/31 (16.13%) 
Red blood cell count decreased * 1  5/32 (15.63%)  2/31 (6.45%) 
Red cell distribution width increased * 1  9/32 (28.13%)  5/31 (16.13%) 
Venous pressure jugular increased * 1  2/32 (6.25%)  4/31 (12.90%) 
Metabolism and nutrition disorders     
Anorexia * 1  2/32 (6.25%)  2/31 (6.45%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/32 (3.13%)  2/31 (6.45%) 
Muscle spasms * 1  2/32 (6.25%)  1/31 (3.23%) 
Myalgia * 1  2/32 (6.25%)  0/31 (0.00%) 
Pain in extremity * 1  1/32 (3.13%)  3/31 (9.68%) 
Nervous system disorders     
Dizziness * 1  1/32 (3.13%)  2/31 (6.45%) 
Headache * 1  8/32 (25.00%)  6/31 (19.35%) 
Paraesthesia * 1  0/32 (0.00%)  2/31 (6.45%) 
Somnolence * 1  1/32 (3.13%)  2/31 (6.45%) 
Tremor * 1  2/32 (6.25%)  0/31 (0.00%) 
Psychiatric disorders     
Insomnia * 1  3/32 (9.38%)  1/31 (3.23%) 
Libido decreased * 1  2/32 (6.25%)  1/31 (3.23%) 
Reproductive system and breast disorders     
Amenorrhoea * 1  2/32 (6.25%)  2/31 (6.45%) 
Erectile dysfunction * 1  1/32 (3.13%)  2/31 (6.45%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  9/32 (28.13%)  6/31 (19.35%) 
Dyspnoea * 1  4/32 (12.50%)  3/31 (9.68%) 
Pharyngolaryngeal pain * 1  0/32 (0.00%)  2/31 (6.45%) 
Skin and subcutaneous tissue disorders     
Periorbital oedema * 1  2/32 (6.25%)  0/31 (0.00%) 
Swelling face * 1  3/32 (9.38%)  2/31 (6.45%) 
Vascular disorders     
Flushing * 1  2/32 (6.25%)  0/31 (0.00%) 
Hypertension * 1  5/32 (15.63%)  5/31 (16.13%) 
Systolic hypertension * 1  2/32 (6.25%)  1/31 (3.23%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All manuscripts, abstracts or other modes of presentation arising from the results of this study must be reviewed and approved in writing by Par, in advance of submission.
Results Point of Contact
Name/Title: Clinical Trial Coordinator
Organization: Endo Pharmaceuticals, Inc.
Publications of Results:
Wanke C; Gutierrez J; Kristensen A; MacEarchern L. Safety and efficacy of two preparations of megestrol acetate in HIV-infected individuals with weight loss in Africa, India, and the United States. J Applied Res 2007;7(3):206-216
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00637572     History of Changes
Other Study ID Numbers: PAR-002
First Submitted: March 11, 2008
First Posted: March 18, 2008
Results First Submitted: January 29, 2016
Results First Posted: April 20, 2016
Last Update Posted: October 5, 2017