Overview

This trial is active, not recruiting.

Conditions weight gain, disorder of bone density and structure, unspecified, uterine bleeding
Treatment depot medroxyprogesterone acetate (dmpa)
Phase phase 3
Sponsor Nationwide Children's Hospital
Collaborator Society of Family Planning
Start date September 2011
End date April 2015
Trial size 45 participants
Trial identifier NCT01461824, IRB11-00583

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
depot medroxyprogesterone acetate (dmpa) Generic Depo Provera manufactured by Greenstone, LLC
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
(Experimental)
depot medroxyprogesterone acetate (dmpa) Generic Depo Provera manufactured by Greenstone, LLC
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
(Experimental)
depot medroxyprogesterone acetate (dmpa) Generic Depo Provera manufactured by Greenstone, LLC
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months

Primary Outcomes

Measure
Number of adolescents who enroll and proportion who return for scheduled follow up visits.
time frame: End of study
Change in lumbar spine bone mineral density (BMD) at 48 weeks
time frame: Week 48
Proportion of participants with >5% weight gain at 24 weeks
time frame: Week 24

Secondary Outcomes

Measure
Change in total hip and femoral neck BMD at 48 weeks
time frame: Week 48
Proportion of subjects with >10% weight gain at 48 weeks
time frame: Week 48

Eligibility Criteria

Female participants from 12 years up to 21 years old.

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.

Additional Information

Official title Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents
Principal investigator Andrea Bonny, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Nationwide Children's Hospital.