- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01461824
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 150 mg DMPA
Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM
|
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Other Names:
|
Experimental: 104mg DMPA
Depot medroxyprogesterone acetate (DMPA) 104 mg every 12 weeks IM
|
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Other Names:
|
Experimental: 75mg DMPA
Depot medroxyprogesterone acetate (DMPA) 75 mg every 12 weeks IM
|
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks
Time Frame: 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.
|
Percent change from baseline to 48 Weeks
|
Proportion of Participants With >5% Weight Gain at 24 Weeks
Time Frame: Week 24
|
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
Time Frame: 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.
|
Percent change from baseline to 48 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrea Bonny, MD, Nationwide Children's Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Uterine Diseases
- Hemorrhage
- Body Weight
- Musculoskeletal Diseases
- Body Weight Changes
- Bone Diseases
- Weight Gain
- Uterine Hemorrhage
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Contraceptive Agents, Male
- Medroxyprogesterone Acetate
- Medroxyprogesterone
Other Study ID Numbers
- IRB11-00583
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Disorder of Bone Density and Structure, Unspecified
-
Oslo University HospitalNycomedCompletedUnspecified Disorder of Bone Density and Structure
-
Rijnstate HospitalCompletedDisorder of Bone Density and Structure, Unspecified | SatisfactionNetherlands
-
Hadassah Medical OrganizationHebrew University of JerusalemCompletedVitamin D Deficiency | Disorder of Bone Density and Structure, UnspecifiedIsrael
-
University of PittsburghCompletedLactation | Other Disorders of Bone Density and Structure | Endocrine; ComplicationsUnited States
-
Massachusetts General HospitalCompletedDisorder of Bone Density and Structure, UnspecifiedUnited States
-
Hellenic Breast Surgeons SocietyCompletedBreast Cancer | Other Disorders of Bone Density and StructureGreece
-
Federal University of Juiz de ForaFundação de Amparo à Pesquisa do estado de Minas GeraisUnknownFatigue | Muscle Weakness | Vitamin D Deficiency | Sarcopenia | Crohn Disease | Disorder of Bone Density and Structure, UnspecifiedBrazil
-
University of BergenHaukeland University HospitalCompletedNeurobehavioral Manifestations | Lung Diseases, Obstructive | Cognition Disorders | Infant, Extremely Low Birth Weight | Disorder of Bone Density and Structure, UnspecifiedNorway
-
University of Turin, ItalyMinistry of Health, ItalyCompletedInflammation | Type 2 Diabetes Mellitus | Insulin Resistance | Other Disorders of Bone Density and StructureItaly
-
GBR AcademyCompletedBone Loss | Soft Tissue Infections | Dental Implant | Surgical Procedure, Unspecified | Bone DensityItaly
Clinical Trials on Depot medroxyprogesterone acetate (DMPA)
-
University of PennsylvaniaCompleted
-
AbbVieCompleted
-
Beatrice ChenSociety of Family PlanningCompletedPostpartum Depression | Contraception | LactationUnited States
-
AIDS Clinical Trials GroupNational Institute of Allergy and Infectious Diseases (NIAID)CompletedTuberculosis | HIV-1 InfectionSouth Africa, Zimbabwe, Botswana, Kenya
-
Women and Infants Hospital of Rhode IslandUnknownGrade 1 Endometrial Endometrioid Adenocarcinoma | Grade 2 Endometrial Endometrioid Adenocarcinoma | Complex Atypical Endometrial HyperplasiaUnited States
-
Emory UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingHormonal ContraceptionUnited States
-
Columbia UniversityCompletedMetrorrhagiaUnited States
-
FHI 360University of Washington; University of North Carolina, Chapel Hill; World Health... and other collaboratorsCompletedHIV | ContraceptionKenya, South Africa, Swaziland, Zambia
-
University of PittsburghUniversity of ZimbabweCompletedHIV | Contraception | Microbiota | Immune Cells (Mucosal and Systemic)Zimbabwe