Clinical trial NCT01461824: Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
Official title: Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Weight Gain
Disorder of Bone Density and Structure, Unspecified
Uterine Bleeding
Keywords: Birth Control
Contraceptive Methods
Female Contraception
Weight Gain
Bone Density
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2011-10-28
Enrollment: 34
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks
timeFrame: Percent change from baseline to 48 Weeks
measure: Proportion of Participants With >5% Weight Gain at 24 Weeks
timeFrame: Week 24
Secondary outcomes:
measure: Percent Change in Total Hip BMD From Baseline to 48 Weeks
timeFrame: Percent change from baseline to 48 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Andrea Bonny, MD
role: PRINCIPAL_INVESTIGATOR
References: