Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects (NCT01461824) | Clinical Trial Compass
CompletedPhase 3
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
United States34 participantsStarted 2011-09
Plain-language 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.
Who can participate
Age range
12 Years – 21 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks
Timeframe: Percent change from baseline to 48 Weeks
2
Proportion of Participants With >5% Weight Gain at 24 Weeks
. 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.