Disorder of Bone Density and Structure, Unspecified, Uterine Bleeding, Weight Gain
Conditions
Keywords
Birth Control, Contraceptive Methods, Female Contraception, Weight Gain, Bone Density
Brief summary
The investigators are doing this study to look at how different doses of the Depot medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens. The investigators hope that what the investigators learn from this study will be used to develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.
Detailed description
Depot medroxyprogesterone acetate (DMPA) is a generic form of the DepoProvera® shot. When receiving the birth control shot some girls gain a lot of weight while others do not. Some girls also lose bone mineral density (BMD). Bone mineral density is the amount of weight and thickness of the bones. In this study 1 of 3 doses of DMPA will be given as an injection into the muscle in the arm. The 150mg dose is approved for use in this age group by the Food and Drug Administration (FDA) when given into the muscle. The 104mg dose is approved for use in this age group by the FDA only when given under the skin therefore it is considered experimental. The 75mg dose is also considered experimental as this dose is not FDA approved regardless of how it is given.
Interventions
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Sponsors
Society of Family Planning
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 12-21 years 2. Healthy, post-menarcheal female 3. Self-selected to initiate depot medroxyprogesterone acetate (DMPA) 4. Willingness to use a barrier method of contraception in addition to DMPA
Exclusion criteria
1. Chronic disease known to affect weight or bone mineral density (BMD) (e.g. diabetes, kidney) 2. Use of medication known to affect weight or BMD (e.g. corticosteroids) 3. DMPA use within the past 12 months 4. Pregnancy within the past 6 months 5. Etonogestrel implant, levonorgestrel-releasing intrauterine system or combined estrogen/progesterone contraceptive use within the past 30 days (OC, patch, vaginal ring) 6. Weight exceeding 450 lbs 7. Need for confidential contraceptive care for individuals \< 18 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks | Percent change from baseline to 48 Weeks | Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated. |
| Proportion of Participants With >5% Weight Gain at 24 Weeks | Week 24 | Individual subjects will be assessed after their Week 24 visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Total Hip BMD From Baseline to 48 Weeks | Percent change from baseline to 48 weeks | Total hip bone mineral density was assessed at baseline and 48 weeks. Percent change from baseline to 48 weeks was calculated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 150 mg DMPA Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months | 12 |
| 104mg DMPA Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months | 11 |
| 75mg DMPA Depot medroxyprogesterone acetate (DMPA): 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months | 11 |
| Total | 34 |
Baseline characteristics
| Characteristic | 150 mg DMPA | 104mg DMPA | 75mg DMPA | Total |
|---|---|---|---|---|
| Age, Continuous | 18.6 years STANDARD_DEVIATION 2.1 | 18.3 years STANDARD_DEVIATION 2.65 | 19.0 years STANDARD_DEVIATION 2.43 | 18.6 years STANDARD_DEVIATION 2.51 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 2 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 9 Participants | 7 Participants | 21 Participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 11 Participants | 34 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 8 / 12 | 11 / 11 | 10 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks
Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated.
Time frame: Percent change from baseline to 48 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 150 mg DMPA | Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks | -4.0 percent change | Standard Deviation 2.76 |
| 104mg DMPA | Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks | -3.1 percent change | Standard Deviation 1.84 |
| 75mg DMPA | Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks | -0.6 percent change | Standard Deviation 5.91 |
Primary
Proportion of Participants With >5% Weight Gain at 24 Weeks
Individual subjects will be assessed after their Week 24 visit.
Time frame: Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 150 mg DMPA | Proportion of Participants With >5% Weight Gain at 24 Weeks | 1 Participants |
| 104mg DMPA | Proportion of Participants With >5% Weight Gain at 24 Weeks | 2 Participants |
| 75mg DMPA | Proportion of Participants With >5% Weight Gain at 24 Weeks | 2 Participants |
Secondary
Percent Change in Total Hip BMD From Baseline to 48 Weeks
Total hip bone mineral density was assessed at baseline and 48 weeks. Percent change from baseline to 48 weeks was calculated.
Time frame: Percent change from baseline to 48 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 150 mg DMPA | Percent Change in Total Hip BMD From Baseline to 48 Weeks | -3.0 Percent change | Standard Deviation 3.22 |
| 104mg DMPA | Percent Change in Total Hip BMD From Baseline to 48 Weeks | -1.6 Percent change | Standard Deviation 2.53 |
| 75mg DMPA | Percent Change in Total Hip BMD From Baseline to 48 Weeks | -0.1 Percent change | Standard Deviation 5.07 |