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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Weight Gain; Disorder of Bone Density and Structure, Unspecified; Uterine Bleeding	Drug: Depot medroxyprogesterone acetate (DMPA)	Phase 3

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	34 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents
Study Start Date :	September 2011
Actual Primary Completion Date :	April 2015
Actual Study Completion Date :	July 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 150 mg DMPA; Depot medroxyprogesterone acetate (DMPA) 150 mg every 12 weeks IM	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; Depot medroxyprogesterone acetate (DMPA) 104 mg every 12 weeks IM	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; Depot medroxyprogesterone acetate (DMPA) 75 mg every 12 weeks IM	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

Outcome Measures

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Primary Outcome Measures :

1. Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks [ Time Frame: Percent change from baseline to 48 Weeks ]
   Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated.
2. Proportion of Participants With >5% Weight Gain at 24 Weeks [ Time Frame: Week 24 ]
   Individual subjects will be assessed after their Week 24 visit.

Secondary Outcome Measures :

1. Percent Change in Total Hip BMD From Baseline to 48 Weeks [ Time Frame: Percent change 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	12 Years to 21 Years (Child, Adult)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	October 28, 2011
Results First Posted:	April 23, 2018
Last Update Posted:	April 23, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Andrea Bonny, Nationwide Children's Hospital:

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

Additional relevant MeSH terms:

Weight Gain; Uterine Hemorrhage; Bone Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Hemorrhage; Pathologic Processes; Musculoskeletal Diseases	Medroxyprogesterone; Medroxyprogesterone Acetate; Contraceptives, Oral, Synthetic; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptive Agents, Male; Antineoplastic Agents, Hormonal; Antineoplastic Agents