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

Primary Purpose

Weight Gain, Disorder of Bone Density and Structure, Unspecified, Uterine Bleeding

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Depot medroxyprogesterone acetate (DMPA)
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Gain focused on measuring Birth Control, Contraceptive Methods, Female Contraception, Weight Gain, Bone Density

Eligibility Criteria

12 Years - 21 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

150 mg DMPA

104mg DMPA

75mg DMPA

Arm Description

Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM

Depot medroxyprogesterone acetate (DMPA) 104 mg every 12 weeks IM

Depot medroxyprogesterone acetate (DMPA) 75 mg every 12 weeks IM

Outcomes

Primary Outcome Measures

Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks
Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated.
Proportion of Participants With >5% Weight Gain at 24 Weeks
Individual subjects will be assessed after their Week 24 visit.

Secondary Outcome Measures

Percent Change in Total Hip BMD 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.

Full Information

First Posted
October 21, 2011
Last Updated
March 23, 2018
Sponsor
Nationwide Children's Hospital
Collaborators
Society of Family Planning
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1. Study Identification

Unique Protocol Identification Number
NCT01461824
Brief Title
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
Official Title
Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
Society of Family Planning

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain, Disorder of Bone Density and Structure, Unspecified, Uterine Bleeding
Keywords
Birth Control, Contraceptive Methods, Female Contraception, Weight Gain, Bone Density

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
150 mg DMPA
Arm Type
Active Comparator
Arm Description
Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM
Arm Title
104mg DMPA
Arm Type
Experimental
Arm Description
Depot medroxyprogesterone acetate (DMPA) 104 mg every 12 weeks IM
Arm Title
75mg DMPA
Arm Type
Experimental
Arm Description
Depot medroxyprogesterone acetate (DMPA) 75 mg every 12 weeks IM
Intervention Type
Drug
Intervention Name(s)
Depot medroxyprogesterone acetate (DMPA)
Other Intervention Name(s)
Generic Depo Provera manufactured by Greenstone, LLC
Intervention Description
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Primary Outcome Measure Information:
Title
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks
Description
Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated.
Time Frame
Percent change from baseline to 48 Weeks
Title
Proportion of Participants With >5% Weight Gain at 24 Weeks
Description
Individual subjects will be assessed after their Week 24 visit.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percent Change in Total Hip BMD From Baseline to 48 Weeks
Description
Total hip bone mineral density was assessed at baseline and 48 weeks. Percent change from baseline to 48 weeks was calculated.
Time Frame
Percent change from baseline to 48 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Bonny, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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