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

March 23, 2018 updated by: Andrea Bonny, Nationwide Children's Hospital

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 150 mg DMPA
Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Other Names:
  • Generic Depo Provera manufactured by Greenstone, LLC
Experimental: 104mg DMPA
Depot medroxyprogesterone acetate (DMPA) 104 mg every 12 weeks IM
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Other Names:
  • Generic Depo Provera manufactured by Greenstone, LLC
Experimental: 75mg DMPA
Depot medroxyprogesterone acetate (DMPA) 75 mg every 12 weeks IM
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Other Names:
  • Generic Depo Provera manufactured by Greenstone, LLC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Percent change from baseline to 48 Weeks
Proportion of Participants With >5% Weight Gain at 24 Weeks
Time Frame: Week 24
Individual subjects will be assessed after their Week 24 visit.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Percent change from baseline to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andrea Bonny, MD, Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 21, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

March 23, 2018

Last Verified

March 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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