Trial Outcomes & Findings for Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects (NCT NCT01461824)
NCT ID: NCT01461824
Last Updated: 2018-04-23
Results Overview
Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
34 participants
Primary outcome timeframe
Percent change from baseline to 48 Weeks
Results posted on
2018-04-23
Participant Flow
Participant milestones
| Measure |
150 mg DMPA
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
104mg DMPA
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
75mg DMPA
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
Baseline characteristics by cohort
| Measure |
150 mg DMPA
n=12 Participants
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
104mg DMPA
n=11 Participants
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
75mg DMPA
n=11 Participants
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
18.6 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
18.3 years
STANDARD_DEVIATION 2.65 • n=7 Participants
|
19.0 years
STANDARD_DEVIATION 2.43 • n=5 Participants
|
18.6 years
STANDARD_DEVIATION 2.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Percent change from baseline to 48 WeeksLumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated.
Outcome measures
| Measure |
150 mg DMPA
n=8 Participants
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
104mg DMPA
n=7 Participants
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
75mg DMPA
n=10 Participants
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
|---|---|---|---|
|
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks
|
-4.0 percent change
Standard Deviation 2.76
|
-3.1 percent change
Standard Deviation 1.84
|
-0.6 percent change
Standard Deviation 5.91
|
PRIMARY outcome
Timeframe: Week 24Individual subjects will be assessed after their Week 24 visit.
Outcome measures
| Measure |
150 mg DMPA
n=8 Participants
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
104mg DMPA
n=9 Participants
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
75mg DMPA
n=10 Participants
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
|---|---|---|---|
|
Proportion of Participants With >5% Weight Gain at 24 Weeks
|
1 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Percent change from baseline to 48 weeksTotal hip bone mineral density was assessed at baseline and 48 weeks. Percent change from baseline to 48 weeks was calculated.
Outcome measures
| Measure |
150 mg DMPA
n=8 Participants
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
104mg DMPA
n=7 Participants
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
75mg DMPA
n=10 Participants
Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
|
|---|---|---|---|
|
Percent Change in Total Hip BMD From Baseline to 48 Weeks
|
-3.0 Percent change
Standard Deviation 3.22
|
-1.6 Percent change
Standard Deviation 2.53
|
-0.1 Percent change
Standard Deviation 5.07
|
Adverse Events
150 mg DMPA
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
104 mg DMPA
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
75 mg DMPA
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
150 mg DMPA
n=12 participants at risk
Depot medroxyprogesterone acetate (DMPA):150mg DMPA, IM, every 12 weeks for 12 months
|
104 mg DMPA
n=11 participants at risk
Depot medroxyprogesterone acetate (DMPA):104mg DMPA, IM, every 12 weeks for 12 months
|
75 mg DMPA
n=11 participants at risk
Depot medroxyprogesterone acetate (DMPA):75mg DMPA, IM, every 12 weeks for 12 months
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
25.0%
3/12 • Up to 48 weeks
Solicited at each visit
|
27.3%
3/11 • Up to 48 weeks
Solicited at each visit
|
27.3%
3/11 • Up to 48 weeks
Solicited at each visit
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
4/12 • Up to 48 weeks
Solicited at each visit
|
72.7%
8/11 • Up to 48 weeks
Solicited at each visit
|
63.6%
7/11 • Up to 48 weeks
Solicited at each visit
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
2/12 • Up to 48 weeks
Solicited at each visit
|
18.2%
2/11 • Up to 48 weeks
Solicited at each visit
|
18.2%
2/11 • Up to 48 weeks
Solicited at each visit
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
|
Infections and infestations
Lip infection
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
|
Infections and infestations
Viral infection not specified
|
16.7%
2/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
|
Immune system disorders
Allergic reaction
|
8.3%
1/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
|
Reproductive system and breast disorders
Uterine pain
|
16.7%
2/12 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
36.4%
4/11 • Up to 48 weeks
Solicited at each visit
|
|
Reproductive system and breast disorders
Urinary tract infection
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
18.2%
2/11 • Up to 48 weeks
Solicited at each visit
|
|
Reproductive system and breast disorders
Irregular menstruation
|
16.7%
2/12 • Up to 48 weeks
Solicited at each visit
|
27.3%
3/11 • Up to 48 weeks
Solicited at each visit
|
18.2%
2/11 • Up to 48 weeks
Solicited at each visit
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
18.2%
2/11 • Up to 48 weeks
Solicited at each visit
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
18.2%
2/11 • Up to 48 weeks
Solicited at each visit
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
18.2%
2/11 • Up to 48 weeks
Solicited at each visit
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
8.3%
1/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.3%
1/12 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
|
Reproductive system and breast disorders
Vaginal infection
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
|
Musculoskeletal and connective tissue disorders
Pain
|
16.7%
2/12 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
18.2%
2/11 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
|
Gastrointestinal disorders
Bloating
|
8.3%
1/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
|
Gastrointestinal disorders
Gastritis
|
8.3%
1/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/12 • Up to 48 weeks
Solicited at each visit
|
0.00%
0/11 • Up to 48 weeks
Solicited at each visit
|
9.1%
1/11 • Up to 48 weeks
Solicited at each visit
|
Additional Information
Dr. Andrea Bonny
The Research Institute at Nationwide Children's Hospital
Phone: 614-722-2450
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place