Phase 3
Completed N=34
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
Weight Gain · Disorder of Bone Density and Structure, Unspecified · Uterine Bleeding
Source: ClinicalTrials.gov NCT01461824 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks — -4.0; -3.1; -0.6 percent change
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks |
-4.0; -3.1; -0.6 | — |
| PRIMARY Proportion of Participants With >5% Weight Gain at 24 Weeks |
1; 2; 2 | — |
| SECONDARY Percent Change in Total Hip BMD From Baseline to 48 Weeks |
-3.0; -1.6; -0.1 | — |
Eligibility Criteria
Inclusion Criteria
- Age 12-21 years
- Healthy, post-menarcheal female
- Self-selected to initiate depot medroxyprogesterone acetate (DMPA)
- Willingness to use a barrier method of contraception in addition to DMPA
Exclusion Criteria
- Chronic disease known to affect weight or bone mineral density (BMD) (e.g. diabetes, kidney)
- Use of medication known to affect weight or BMD (e.g. corticosteroids)
- DMPA use within the past 12 months
- Pregnancy within the past 6 months
- Etonogestrel implant, levonorgestrel-releasing intrauterine system or combined estrogen/progesterone contraceptive use within the past 30 days (OC, patch, vaginal ring)
- Weight exceeding 450 lbs
- Need for confidential contraceptive care for individuals < 18 years of age.
Data sourced from ClinicalTrials.gov (NCT01461824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.