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Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women

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ClinicalTrials.gov Identifier: NCT02937766
Recruitment Status : Terminated (The Sponsor elected to discontinue the study prematurely due to business reasons)
First Posted : October 19, 2016
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women
Intervention Drug: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description

Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Period Title: Overall Study
Started 30 30
Completed 23 30
Not Completed 7 0
Arm/Group Title Treatment A Treatment B Total
Hide Arm/Group Description

Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
  76.7%
27
  90.0%
50
  83.3%
>=65 years
7
  23.3%
3
  10.0%
10
  16.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
59.3  (6.39) 56.5  (4.23) 57.9  (5.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
30
 100.0%
30
 100.0%
60
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30
 100.0%
30
 100.0%
60
 100.0%
1.Primary Outcome
Title Comparison of Average Pain Intensity
Hide Description

Comparison of average pain intensity associated with the administration of Makena® via subcutaneous autoinjector versus intramuscular injection (averaged over 4 visits).

Score on a scale: 0 (No Pain) up to 10 (Worst Pain Imaginable)

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Comparison of Average Pain Intensity outcome was not analyzed. Pain assessments for participants included Adverse Events of Injection Site Pain reporting. 3 participants in Treatment Group A and 2 participants in Treatment Group B reported Injection Site Pain.
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:

Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Participants with Injection Site Pain
3 2
2.Secondary Outcome
Title Clinician Assessment of Ease of Injection Technique
Hide Description

Investigate the clinician’s assessment of the ease of injection technique associated with the administration of Makena® via subcutaneous auto-injector versus intramuscular injection as measured by a categorical scale.

Scores were as follows: completely dissatisfied = -3; mostly dissatisfied = -2, somewhat dissatisfied = -1, neither satisfied nor unsatisfied = 0, somewhat satisfied = 1, mostly satisfied = 2, completely satisfied = 3

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is comprised of all subjects who were randomized and received study drug.
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:

Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.8  (0.43) 2.3  (1.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment A, Treatment B
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.093
Comments [Not Specified]
Method t-test, 2 sided
Comments The t-test tested the hypothesis of no treatment difference between treatment groups.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.1 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Clinician Assessment of Ease of Drug Preparation
Hide Description

Investigate the clinician’s assessment of the ease of drug preparation associated with the administration of Makena® via subcutaneous auto-injector versus intramuscular injection as measured by a categorical scale.

Scores were as follows: completely dissatisfied = -3; mostly dissatisfied = -2, somewhat dissatisfied = -1, neither satisfied nor unsatisfied = 0, somewhat satisfied = 1, mostly satisfied = 2, completely satisfied = 3

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population is comprised of all subjects who were randomized and received study drug.
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:

Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.8  (0.43) 2.5  (1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment A, Treatment B
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.234
Comments The t-test tested the hypothesis of no treatment difference between treatment groups.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.2 to 0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments [Not Specified]
Time Frame Approximately 66 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description

Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

All-Cause Mortality
Treatment A Treatment B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment A Treatment B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      0/30 (0.00%)    
Injury, poisoning and procedural complications     
Tibia fracture  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment A Treatment B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/30 (56.67%)      13/30 (43.33%)    
Gastrointestinal disorders     
Nausea  1  1/30 (3.33%)  1 2/30 (6.67%)  2
Toothache  1  0/30 (0.00%)  0 2/30 (6.67%)  2
Abdominal distension  1  0/30 (0.00%)  0 1/30 (3.33%)  1
Abdominal pain  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Dry mouth  1  0/30 (0.00%)  0 1/30 (3.33%)  2
General disorders     
Injection site pain  1  3/30 (10.00%)  3 2/30 (6.67%)  2
Fatigue  1  1/30 (3.33%)  1 1/30 (3.33%)  1
Injection site erythema  1  2/30 (6.67%)  2 0/30 (0.00%)  0
Injection site nodule  1  2/30 (6.67%)  2 0/30 (0.00%)  0
Injection site paraesthesia  1  0/30 (0.00%)  0 1/30 (3.33%)  1
Injection site pruritis  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Injection site swelling  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Infections and infestations     
Upper respiratory tract infection  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Injury, poisoning and procedural complications     
Foot fracture  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Procedural pain  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Investigations     
Cardiac murmur  1  0/30 (0.00%)  0 1/30 (3.33%)  1
Liver function test increased  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  0/30 (0.00%)  0 1/30 (3.33%)  1
Polydipsia  1  0/30 (0.00%)  0 1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders     
Musculoskeletal stiffness  1  1/30 (3.33%)  2 1/30 (3.33%)  1
Myalgia  1  2/30 (6.67%)  2 0/30 (0.00%)  0
Musculoskeletal pain  1  1/30 (3.33%)  2 0/30 (0.00%)  0
Neck pain  1  1/30 (3.33%)  2 0/30 (0.00%)  0
Nervous system disorders     
Headache  1  1/30 (3.33%)  1 3/30 (10.00%)  4
Dizziness  1  1/30 (3.33%)  1 1/30 (3.33%)  2
Paraesthesia  1  2/30 (6.67%)  2 0/30 (0.00%)  0
Somnolence  1  0/30 (0.00%)  0 1/30 (3.33%)  1
Psychiatric disorders     
Irritability  1  1/30 (3.33%)  1 1/30 (3.33%)  1
Reproductive system and breast disorders     
Uterine haemorrhage  1  2/30 (6.67%)  3 1/30 (3.33%)  1
Skin and subcutaneous tissue disorders     
Ecchymosis  1  1/30 (3.33%)  1 0/30 (0.00%)  0
Vascular disorders     
Hot flush  1  2/30 (6.67%)  2 0/30 (0.00%)  0
Hypertension  1  2/30 (6.67%)  2 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 19.0
The Sponsor elected to discontinue the study prematurely due to business reasons. The only parameters analyzed for efficacy were Ease of Drug Preparation and Ease of Injection Technique.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Medical Information
Organization: AMAG Pharmaceuticals, Inc.
Phone: 1-877-411-2510
Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02937766     History of Changes
Other Study ID Numbers: AMAG-HPC-HPM-301
First Submitted: October 17, 2016
First Posted: October 19, 2016
Results First Submitted: April 26, 2018
Results First Posted: December 12, 2018
Last Update Posted: December 12, 2018