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

Phase 3

Completed

• Conditions: Weight Gain; Disorder of Bone Density and Structure, Unspecified; Uterine Bleeding
• Interventions: Drug: Depot medroxyprogesterone acetate (DMPA)

• Registration Number: NCT01461824
• Lead Sponsor: Nationwide Children's Hospital

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-21
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-28
• Primary Completion: 2015-04
• Study Completion: 2016-07
• Results First Submitted: 2017-10-11
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-23
• Last Update Submitted: 2018-03-23
• Results First Posted: 2018-04-23
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
104mg DMPA	Depot medroxyprogesterone acetate (DMPA)	Depot medroxyprogesterone acetate (DMPA) 104 mg every 12 weeks IM
150 mg DMPA	Depot medroxyprogesterone acetate (DMPA)	Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM
75mg DMPA	Depot medroxyprogesterone acetate (DMPA)	Depot medroxyprogesterone acetate (DMPA) 75 mg every 12 weeks IM

Primary Outcome Measures

Name	Time	Method
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks	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.
Proportion of Participants With >5% Weight Gain at 24 Weeks	Week 24	Individual subjects will be assessed after their Week 24 visit.

Secondary Outcome Measures

Name	Time	Method
Percent Change in Total Hip BMD From Baseline to 48 Weeks	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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States