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

NCT01461824 | Completed Phase 3 Results DMC

• 1 other identifier: IRB11-00583
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Weight Gain; Disorder of Bone Density and Structure, Unspecified; Uterine Bleeding

Keywords

Birth Control; Contraceptive Methods; Female Contraception; Weight Gain; Bone Density

Outcome Measures

Primary Outcomes (2)

• 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

• Proportion of Participants With >5% Weight Gain at 24 Weeks

  Individual subjects will be assessed after their Week 24 visit.

  Week 24

Secondary Outcomes (1)

• Percent Change in Total Hip BMD From Baseline to 48 Weeks

  Percent change from baseline to 48 weeks

Study Arms (3)

150 mg DMPA

ACTIVE COMPARATOR

Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM

Drug: Depot medroxyprogesterone acetate (DMPA)

104mg DMPA

EXPERIMENTAL

Depot medroxyprogesterone acetate (DMPA) 104 mg every 12 weeks IM

Drug: Depot medroxyprogesterone acetate (DMPA)

75mg DMPA

EXPERIMENTAL

Depot medroxyprogesterone acetate (DMPA) 75 mg every 12 weeks IM

Drug: Depot medroxyprogesterone acetate (DMPA)

Interventions

Depot medroxyprogesterone acetate (DMPA) DRUG

75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months

Also known as: Generic Depo Provera manufactured by Greenstone, LLC

104mg DMPA; 150 mg DMPA; 75mg DMPA

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 30 days (OC, patch, vaginal ring)
• Weight exceeding 450 lbs
• Need for confidential contraceptive care for individuals \< 18 years of age.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Society of Family Planning: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Weight Gain; Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes

Results Point of Contact

• Title: Dr. Andrea Bonny
• Organization: The Research Institute at Nationwide Children's Hospital

andrea.bonny@nationwidechildrens.org

614-722-2450

Study Officials

• Andrea Bonny, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Pediatrics, The Ohio State University

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: October 28, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: July 1, 2016
• Last Updated: April 23, 2018
• Results First Posted: April 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)