Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
This study is currently recruiting participants.
Verified June 2012 by Nationwide Children's Hospital
Sponsor:
Nationwide Children's Hospital
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Andrea Bonny, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01461824
First received: October 21, 2011
Last updated: June 26, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Weight Gain Disorder of Bone Density and Structure, Unspecified |
Drug: Depot medroxyprogesterone acetate (DMPA) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents |
Resource links provided by NLM:
Further study details as provided by Nationwide Children's Hospital:
Primary Outcome Measures:
- Number of adolescents who enroll and proportion who return for scheduled follow up visits. [ Time Frame: End of study ] [ Designated as safety issue: No ]Subject participation is 48 weeks, enrollment period is up to 12 months so the estimated time for analysis is after all study visits are complete, which may be up to 2 years.
- Change in lumbar spine bone mineral density (BMD) at 48 weeks [ Time Frame: Week 48 ] [ Designated as safety issue: No ]Individual subjects will be assessed after their Week 48 visit.
- Proportion of participants with >5% weight gain at 24 weeks [ Time Frame: Week 24 ] [ Designated as safety issue: No ]Individual subjects will be assessed after their Week 24 visit.
Secondary Outcome Measures:
- Change in total hip and femoral neck BMD at 48 weeks [ Time Frame: Week 48 ] [ Designated as safety issue: No ]Individual subjects will be assessed after their Week 48 visit.
- Proportion of subjects with >10% weight gain at 48 weeks [ Time Frame: Week 48 ] [ Designated as safety issue: No ]Individual subjects will be assessed after their Week 48 visit.
| Estimated Enrollment: | 45 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 150 mg DMPA |
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 |
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 |
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
|
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| Ages Eligible for Study: | 12 Years to 21 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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 3 months (OC, patch, vaginal ring)
- Weight exceeding 250 lbs
- Need for confidential contraceptive care for individuals < 18 years of age.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461824
Locations
| United States, Ohio | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Lauren Bird, RN 614-722-2650 Lauren.Bird@NationwideChildrens.org | |
| Contact: Hannah Lange, MPH 614-722-3465 Hannah.Lange@NationwideChildrens.org | |
| Principal Investigator: Andrea Bonny, MD | |
Sponsors and Collaborators
Nationwide Children's Hospital
Society of Family Planning
Investigators
| Principal Investigator: | Andrea Bonny, MD | Nationwide Children's Hospital |
More Information
No publications provided
| 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 |
| Study First Received: | October 21, 2011 |
| Last Updated: | June 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Nationwide Children's Hospital:
|
Birth Control Contraceptive Methods Female Contraception Weight Gain Bone Density |
Additional relevant MeSH terms:
|
Bone Diseases Weight Gain Musculoskeletal Diseases Body Weight Changes Body Weight Signs and Symptoms Medroxyprogesterone Medroxyprogesterone Acetate Contraceptives, Oral, Synthetic Contraceptives, Oral |
Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Male Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013