Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01461824
Other study ID # IRB11-00583
Secondary ID
Status Completed
Phase Phase 3
First received October 21, 2011
Last updated March 23, 2018
Start date September 2011
Est. completion date July 2016

Study information

Verified date March 2018
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date July 2016
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 12 Years to 21 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Depot medroxyprogesterone acetate (DMPA)
75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Nationwide Children's Hospital Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change in Lumbar Spine Bone Mineral Density (BMD) 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
Primary Proportion of Participants With >5% Weight Gain at 24 Weeks Individual subjects will be assessed after their Week 24 visit. Week 24
Secondary Percent Change in Total Hip BMD 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03249896 - Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes N/A
Recruiting NCT04043520 - Bioenergetic Effects of Aging and Menopause (BEAM) Phase 4
Completed NCT05508750 - Growth and Safety Clinical Trial on a New Infant Formula N/A
Not yet recruiting NCT03225456 - Oxytocin and Eating Phase 2
Completed NCT02227043 - Study Of Weight Development Over Time N/A
Completed NCT01958307 - Healthy Living in Pregnancy N/A
Not yet recruiting NCT01916603 - Diet, Physical Activity and Breastfeeding Intervention on Maternal Nutrition, Offspring Growth and Development N/A
Completed NCT01693666 - Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study) N/A
Terminated NCT00759993 - Chromium Piccolinate in the Prevention of Weight Gain Induced by Serotonergic Medications Initiated on Psychiatric Inpatient Units. Phase 2
Completed NCT00634530 - Impact of a Nutritional Intervention Program for Weight Control During Pregnancy N/A
Completed NCT00995462 - Prevention of Weight Gain in University Students N/A
Completed NCT00122213 - A Physical Activity and Diet Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women Phase 2
Completed NCT00306449 - Prevention of Weight Gain in Young Adults N/A
Completed NCT03996551 - ExeRTiOn2- The Weight Gain Prevention Exercise in Renal Transplant Online Study N/A
Recruiting NCT03675464 - Study of Human Adipose Tissue (LOSHAT)
Completed NCT04282655 - Effect of Milk Warming on the Very Low Birth Weight Infant N/A
Recruiting NCT05992688 - The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time) N/A
Completed NCT04069351 - Body Composition Changes During Overfeeding Plus Resistance Training N/A
Completed NCT00687115 - Predicting Weight Gain and Weight Loss Associated With Overeating or Fasting Phase 2
Withdrawn NCT05556577 - Weight Cycle Post Intervention