Trial Outcomes & Findings for 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 (NCT NCT02937766)

Last Updated: 2022-04-21

Results Overview

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)

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

4 weeks

Results posted on

2022-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment A Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)	Treatment B Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Overall Study STARTED	30	30
Overall Study COMPLETED	23	30
Overall Study NOT COMPLETED	7	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment A n=30 Participants Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)	Treatment B n=30 Participants Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	27 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	59.3 years STANDARD_DEVIATION 6.39 • n=5 Participants	56.5 years STANDARD_DEVIATION 4.23 • n=7 Participants	57.9 years STANDARD_DEVIATION 5.55 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Treatment A n=30 Participants Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)	Treatment B n=30 Participants Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Comparison of Average Pain Intensity	3 Participants with Injection Site Pain	2 Participants with Injection Site Pain

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis population is comprised of all subjects who were randomized and received study drug.

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

Outcome measures

Outcome measures
Measure	Treatment A n=30 Participants Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)	Treatment B n=30 Participants Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Clinician Assessment of Ease of Injection Technique	2.8 units on a scale Standard Deviation 0.43	2.3 units on a scale Standard Deviation 1.32

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis population is comprised of all subjects who were randomized and received study drug.

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

Outcome measures

Outcome measures
Measure	Treatment A n=30 Participants Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)	Treatment B n=30 Participants Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Clinician Assessment of Ease of Drug Preparation	2.8 units on a scale Standard Deviation 0.43	2.5 units on a scale Standard Deviation 1.14

Adverse Events

Treatment A

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Treatment B

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment A n=30 participants at risk Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)	Treatment B n=30 participants at risk Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Injury, poisoning and procedural complications Tibia fracture	3.3% 1/30 • Number of events 1 • Approximately 66 days	0.00% 0/30 • Approximately 66 days

Other adverse events

Other adverse events
Measure	Treatment A n=30 participants at risk Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)	Treatment B n=30 participants at risk Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections) Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
General disorders Injection site pain	10.0% 3/30 • Number of events 3 • Approximately 66 days	6.7% 2/30 • Number of events 2 • Approximately 66 days
General disorders Fatigue	3.3% 1/30 • Number of events 1 • Approximately 66 days	3.3% 1/30 • Number of events 1 • Approximately 66 days
General disorders Injection site erythema	6.7% 2/30 • Number of events 2 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
General disorders Injection site nodule	6.7% 2/30 • Number of events 2 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
General disorders Injection site paraesthesia	0.00% 0/30 • Approximately 66 days	3.3% 1/30 • Number of events 1 • Approximately 66 days
General disorders Injection site pruritis	3.3% 1/30 • Number of events 1 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
General disorders Injection site swelling	3.3% 1/30 • Number of events 1 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
Nervous system disorders Headache	3.3% 1/30 • Number of events 1 • Approximately 66 days	10.0% 3/30 • Number of events 4 • Approximately 66 days
Nervous system disorders Dizziness	3.3% 1/30 • Number of events 1 • Approximately 66 days	3.3% 1/30 • Number of events 2 • Approximately 66 days
Nervous system disorders Paraesthesia	6.7% 2/30 • Number of events 2 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
Nervous system disorders Somnolence	0.00% 0/30 • Approximately 66 days	3.3% 1/30 • Number of events 1 • Approximately 66 days
Gastrointestinal disorders Nausea	3.3% 1/30 • Number of events 1 • Approximately 66 days	6.7% 2/30 • Number of events 2 • Approximately 66 days
Gastrointestinal disorders Toothache	0.00% 0/30 • Approximately 66 days	6.7% 2/30 • Number of events 2 • Approximately 66 days
Gastrointestinal disorders Abdominal distension	0.00% 0/30 • Approximately 66 days	3.3% 1/30 • Number of events 1 • Approximately 66 days
Gastrointestinal disorders Abdominal pain	3.3% 1/30 • Number of events 1 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
Gastrointestinal disorders Dry mouth	0.00% 0/30 • Approximately 66 days	3.3% 1/30 • Number of events 2 • Approximately 66 days
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	3.3% 1/30 • Number of events 2 • Approximately 66 days	3.3% 1/30 • Number of events 1 • Approximately 66 days
Musculoskeletal and connective tissue disorders Myalgia	6.7% 2/30 • Number of events 2 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.3% 1/30 • Number of events 2 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
Musculoskeletal and connective tissue disorders Neck pain	3.3% 1/30 • Number of events 2 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
Vascular disorders Hot flush	6.7% 2/30 • Number of events 2 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
Vascular disorders Hypertension	6.7% 2/30 • Number of events 2 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
Reproductive system and breast disorders Uterine haemorrhage	6.7% 2/30 • Number of events 3 • Approximately 66 days	3.3% 1/30 • Number of events 1 • Approximately 66 days
Investigations Cardiac murmur	0.00% 0/30 • Approximately 66 days	3.3% 1/30 • Number of events 1 • Approximately 66 days
Investigations Liver function test increased	3.3% 1/30 • Number of events 1 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
Psychiatric disorders Irritability	3.3% 1/30 • Number of events 1 • Approximately 66 days	3.3% 1/30 • Number of events 1 • Approximately 66 days
Infections and infestations Upper respiratory tract infection	3.3% 1/30 • Number of events 1 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
Injury, poisoning and procedural complications Foot fracture	3.3% 1/30 • Number of events 1 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
Injury, poisoning and procedural complications Procedural pain	3.3% 1/30 • Number of events 1 • Approximately 66 days	0.00% 0/30 • Approximately 66 days
Metabolism and nutrition disorders Decreased appetite	0.00% 0/30 • Approximately 66 days	3.3% 1/30 • Number of events 1 • Approximately 66 days
Metabolism and nutrition disorders Polydipsia	0.00% 0/30 • Approximately 66 days	3.3% 1/30 • Number of events 1 • Approximately 66 days
Skin and subcutaneous tissue disorders Ecchymosis	3.3% 1/30 • Number of events 1 • Approximately 66 days	0.00% 0/30 • Approximately 66 days

Additional Information

Medical Information

AMAG Pharmaceuticals, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place