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

Weight Gain Clinical Trial

Official title:

Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461824
• Other study ID #: IRB11-00583
• 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
• 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.

Related Conditions & MeSH terms

• Bone Diseases
• Disorder of Bone Density and Structure, Unspecified
• Uterine Bleeding
• Uterine Hemorrhage
• Weight Gain

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