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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-07-31

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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150 mg DMPA

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

Group Type ACTIVE_COMPARATOR

Depot medroxyprogesterone acetate (DMPA)

Intervention Type DRUG

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

104mg DMPA

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

Group Type EXPERIMENTAL

Depot medroxyprogesterone acetate (DMPA)

Intervention Type DRUG

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

75mg DMPA

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

Group Type EXPERIMENTAL

Depot medroxyprogesterone acetate (DMPA)

Intervention Type DRUG

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

Interventions

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Depot medroxyprogesterone acetate (DMPA)

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

Intervention Type DRUG

Other Intervention Names

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Generic Depo Provera manufactured by Greenstone, LLC

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes