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

Nationwide Children's Hospital34 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

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

Interventions

Depot medroxyprogesterone acetate (DMPA)DRUG

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

Eligibility

Sex: FEMALEMin age: 12 YearsMax age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Week 24

Secondary Outcomes

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.

Time frame: Percent change from baseline to 48 weeks

Data from ClinicalTrials.gov

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