Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
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ClinicalTrials.gov Identifier: NCT01461824 |
Recruitment Status
:
Completed
First Posted
: October 28, 2011
Results First Posted
: April 23, 2018
Last Update Posted
: April 23, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Weight Gain Disorder of Bone Density and Structure, Unspecified Uterine Bleeding | Drug: Depot medroxyprogesterone acetate (DMPA) | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 150 mg DMPA
Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM
|
Drug: Depot medroxyprogesterone acetate (DMPA)
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Other Name: Generic Depo Provera manufactured by Greenstone, LLC
|
Experimental: 104mg DMPA
Depot medroxyprogesterone acetate (DMPA) 104 mg every 12 weeks IM
|
Drug: Depot medroxyprogesterone acetate (DMPA)
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Other Name: Generic Depo Provera manufactured by Greenstone, LLC
|
Experimental: 75mg DMPA
Depot medroxyprogesterone acetate (DMPA) 75 mg every 12 weeks IM
|
Drug: Depot medroxyprogesterone acetate (DMPA)
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Other Name: Generic Depo Provera manufactured by Greenstone, LLC
|
- 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.
- Proportion of Participants With >5% Weight Gain at 24 Weeks [ Time Frame: Week 24 ]Individual subjects will be assessed after their Week 24 visit.
- 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.

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Ages Eligible for Study: | 12 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461824
United States, Ohio | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43205 |
Principal Investigator: | Andrea Bonny, MD | Nationwide Children's Hospital |
Responsible Party: | Andrea Bonny, Assistant Professor, Department of Pediatrics, The Ohio State University, Nationwide Children's Hospital |
ClinicalTrials.gov Identifier: | NCT01461824 History of Changes |
Other Study ID Numbers: |
IRB11-00583 |
First Posted: | October 28, 2011 Key Record Dates |
Results First Posted: | April 23, 2018 |
Last Update Posted: | April 23, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Andrea Bonny, Nationwide Children's Hospital:
Birth Control Contraceptive Methods Female Contraception Weight Gain Bone Density |
Additional relevant MeSH terms:
Weight Gain Uterine Hemorrhage Bone Diseases Body Weight Changes Body Weight Signs and Symptoms Uterine Diseases Genital Diseases, Female Hemorrhage Pathologic Processes Musculoskeletal Diseases |
Medroxyprogesterone Medroxyprogesterone Acetate Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptive Agents, Male Antineoplastic Agents, Hormonal Antineoplastic Agents |