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OpenTrials
Completed

NCT Number: NCT01461824

Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Depot medroxyprogesterone acetate (DMPA)

Drug

75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months

Other names: Generic Depo Provera manufactured by Greenstone, LLC

Primary outcomes

  1. Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks

    Time frame: 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.

  2. Proportion of Participants With >5% Weight Gain at 24 Weeks

    Time frame: Week 24

    Individual subjects will be assessed after their Week 24 visit.

Secondary outcomes

  1. Percent Change in Total Hip BMD From Baseline to 48 Weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Oct 28, 2011
Registry last updated
Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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