Trial Outcomes & Findings for PK of Depo SubQ Injected in the Upper Arm (NCT NCT01143207)
NCT ID: NCT01143207
Last Updated: 2013-08-19
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
120 days following injection
Results posted on
2013-08-19
Participant Flow
Participant milestones
| Measure |
Medroxyprogesterone Acetate
Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Medroxyprogesterone Acetate
Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
PK of Depo SubQ Injected in the Upper Arm
Baseline characteristics by cohort
| Measure |
Medroxyprogesterone Acetate
n=26 Participants
Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 120 days following injectionOutcome measures
| Measure |
Medroxyprogesterone Acetate
n=25 Participants
Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive
|
|---|---|
|
Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))
|
0.953 ng/mL
Standard Deviation 0.308 • Interval 2.0 to 14.0
|
PRIMARY outcome
Timeframe: 120 days following injectionOutcome measures
| Measure |
Medroxyprogesterone Acetate
n=25 Participants
Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive
|
|---|---|
|
Tmax (Time to Cmax)
|
8 days
Interval 2.0 to 14.0
|
PRIMARY outcome
Timeframe: first 91 days following injectionOutcome measures
| Measure |
Medroxyprogesterone Acetate
n=24 Participants
Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive
|
|---|---|
|
AUC 0-91 (Area Under Curve)
|
45.1 ng day/mL
Standard Deviation 14.5
|
PRIMARY outcome
Timeframe: day 91 after first injectionOutcome measures
| Measure |
Medroxyprogesterone Acetate
n=22 Participants
Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive
|
|---|---|
|
MPA Concentration at Day 91 (C91)
|
0.427 ng/mL
Standard Deviation 0.354
|
PRIMARY outcome
Timeframe: day 104 after injectionOutcome measures
| Measure |
Medroxyprogesterone Acetate
n=23 Participants
Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive
|
|---|---|
|
MPA Concentration at Day 104 (C104)
|
0.366 ng/mL
Standard Deviation 0.278
|
PRIMARY outcome
Timeframe: day 120 after injectionOutcome measures
| Measure |
Medroxyprogesterone Acetate
n=23 Participants
Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive
|
|---|---|
|
MPA Concentration at Day 120 (C120)
|
0.327 ng/mL
Standard Deviation 0.206
|
Adverse Events
Medroxyprogesterone Acetate
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Medroxyprogesterone Acetate
n=26 participants at risk
Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive
|
|---|---|
|
Psychiatric disorders
Bipolar Disorder
|
3.8%
1/26 • Number of events 1
|
|
Surgical and medical procedures
Hysterectomy
|
3.8%
1/26 • Number of events 1
|
Other adverse events
| Measure |
Medroxyprogesterone Acetate
n=26 participants at risk
Single injection of Medroxyprogesterone acetate (hormonal contraceptive)
Medroxyprogesterone acetate : Injectable hormonal contraceptive
|
|---|---|
|
Musculoskeletal and connective tissue disorders
back pain
|
7.7%
2/26 • Number of events 2
|
|
Reproductive system and breast disorders
vaginal infection (bacterial vaginosis)
|
7.7%
2/26 • Number of events 2
|
|
Renal and urinary disorders
bladder pain
|
3.8%
1/26 • Number of events 1
|
|
Investigations
Biopsy breast
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Dental infection
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Dental pain
|
3.8%
1/26 • Number of events 1
|
|
Psychiatric disorders
Bipolar disorder
|
3.8%
1/26 • Number of events 1
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Dispepsia
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Injection site pain
|
3.8%
1/26 • Number of events 1
|
|
Reproductive system and breast disorders
Menstruation irregular
|
3.8%
1/26 • Number of events 1
|
|
Eye disorders
Corneal abrasion
|
3.8%
1/26 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
3.8%
1/26 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.8%
1/26 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.8%
1/26 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
3.8%
1/26 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.8%
1/26 • Number of events 1
|
|
Renal and urinary disorders
Pyelonephritis
|
3.8%
1/26 • Number of events 1
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
3.8%
1/26 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis (sinus congestion)
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis (sinus headache)
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.8%
1/26 • Number of events 1
|
|
Surgical and medical procedures
Hysterectomy
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Viral infection
|
3.8%
1/26 • Number of events 1
|
|
Surgical and medical procedures
Tooth extraction
|
3.8%
1/26 • Number of events 1
|
|
Reproductive system and breast disorders
Vulvovaginal candidiasis (yeast infection)
|
3.8%
1/26 • Number of events 1
|
|
Reproductive system and breast disorders
Vulvovaginal candidiasis (vaginal yeast infection)
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
sinusitis (congestion)
|
3.8%
1/26 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place