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

This study is ongoing, but not recruiting participants.
Sponsor:
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 18, 2014
Last verified: June 2014
  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: March 2015
Estimated Primary Completion Date: October 2014 (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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461824

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
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 18, 2014
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 July 22, 2014