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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Depot medroxyprogesterone acetate (DMPA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 150 mg DMPA<br>Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM | Drug: Depot medroxyprogesterone acetate (DMPA)<br>* 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months<br>* Other names: Generic Depo Provera manufactured by Greenstone, LLC;|
| Experimental: 104mg DMPA<br>Depot medroxyprogesterone acetate (DMPA) 104 mg every 12 weeks IM | Drug: Depot medroxyprogesterone acetate (DMPA)<br>* 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months<br>* Other names: Generic Depo Provera manufactured by Greenstone, LLC;|
| Experimental: 75mg DMPA<br>Depot medroxyprogesterone acetate (DMPA) 75 mg every 12 weeks IM | Drug: Depot medroxyprogesterone acetate (DMPA)<br>* 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months<br>* Other names: Generic Depo Provera manufactured by Greenstone, LLC;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Birth Control, Contraceptive Methods, Female Contraception, Weight Gain, Bone Density