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

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

• Status: Completed
• Conditions: Disorder of Bone Density and Structure, Unspecified; Weight Gain; Uterine Bleeding
• Intervention / Treatment: Drug: Depot medroxyprogesterone acetate (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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 150 mg DMPA; Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM	Drug: Depot medroxyprogesterone acetate (DMPA); 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	Drug: Depot medroxyprogesterone acetate (DMPA); 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	Drug: Depot medroxyprogesterone acetate (DMPA); 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	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	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	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

• Sponsor: Nationwide Children's Hospital
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Andrea Bonny, MD, Nationwide Children's Hospital

Study record dates

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

Terms related to this study

• Keywords: Weight Gain; Bone Density; Contraceptive Methods; Female Contraception; Birth Control
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Body Weight; Musculoskeletal Diseases; Body Weight Changes; Bone Diseases; Weight Gain; Uterine Hemorrhage; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Medroxyprogesterone Acetate; Medroxyprogesterone
• Other Study ID Numbers: IRB11-00583

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No