Trials / Completed
CompletedNCT01461824
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Nationwide Children's Hospital · Academic / Other
- Sex
- Female
- Age
- 12 Years – 21 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Depot medroxyprogesterone acetate (DMPA) | 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2015-04-01
- Completion
- 2016-07-01
- First posted
- 2011-10-28
- Last updated
- 2018-04-23
- Results posted
- 2018-04-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01461824. Inclusion in this directory is not an endorsement.